Muscular AtrophyNCT02495727
Two Weeks of Reduced Activity and Skeletal Muscle Health in Older Men
A study testing Step-reduction, Pre-training and Exercise snacking in people with Muscular Atrophy, run by University of Bath at 1 site in United Kingdom.
Trial summary
Muscle size declines at around 0.5-1% per year after 50 years of age, with muscle strength declining up to twice as fast as muscle size. This may eventually lead to loss of independence if tasks of daily living become too strenuous to be performed safely. Read more about this study
- Who is it for?
- Ages 65 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscular Atrophy
- What is being tested?
- Step-reduction, Pre-training and Exercise snacking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65 to 80 years
- Not underweight or obese (body mass index ≥20 and ≤ 30 kg/m2)
- Non-smoker (for >5 years)
- Healthy (see exclusion criteria)
Who cannot join
- Any chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, peripheral arterial disease, insulin- or non-insulin dependent diabetes or other metabolic disorders - all ascertained through medical screening.
- Individuals who consume on a daily basis any analgesic or anti-inflammatory drug(s), prescription or non-prescription will be excluded.
- Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).
- Individuals with a history of bone, joint or neuromuscular problems or a current musculoskeletal injury ascertained through medical screening.
- Individuals with a known bleeding disorder, on the anticoagulant drug Warfarin, or prone to keloid scarring.
- Individuals with a known negative reaction to lidocaine anaesthetic.
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- Individuals with any joint replacement surgical implants or other artefacts containing metal.
- Individuals who complete fewer than 3500 steps per day (as assessed by pedometer prior to the study).
- Individuals who score less than 8 on the short physical performance battery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 14-days of Reduced Physical Activity on Muscle Function and Size, Inflammatory Profile, and Exercise-induced Activation of Stress Responses in Skeletal Muscle in Healthy Older Males
Muscle size declines at around 0.5-1% per year after 50 years of age, with muscle strength declining up to twice as fast as muscle size. This may eventually lead to loss of independence if tasks of daily living become too strenuous to be performed safely. Short periods of bed rest cause very rapid loss of muscle size and strength, and studies using healthy older participants have shown that age increases vulnerability to this muscle loss. However, it is unlikely that healthy individuals would be faced with periods of bed rest unless suffering a severe illness. In light of this, recent evidence has shown that even just reducing walking to less than 1,500 steps per day for two weeks caused 4% loss of leg muscle in over 65 year olds. This amount of activity is roughly the equivalent of being housebound, something that may become more common into older age, for example due to prolonged bad weather, or minor injury or illness.
This study will investigate what causes such stark muscle loss during two weeks of reduced activity, and the impact on skeletal muscle function and size, as well as balance, body composition, and other indicators of general health such as how the body responds to food or exercise. Importantly, exercise strategies that could reduce muscle loss during a period of reduced activity will also be investigated.
In brief, three groups of 10 older men (aged 65-80 years) will undertake two weeks of reduced physical activity by limiting their daily steps to <1,500/day. All groups will then undertake a re-training exercise programme to ensure that any losses in muscle strength or size are regained. One of the groups will be a control, whereby they will undertake the step-reduction intervention and re-training, but no protective exercise before or during the step-reduction intervention. This group will allow us to achieve our primary objective of determining the influence of two weeks of reduced physical activity on muscle strength and size in healthy older males. The two other groups will undertake either four weeks of strength exercise training before the step-reduction intervention, or daily home based exercise 'snacking' during the step-reduction intervention. The potential protective benefits of the exercise interventions in reducing the impact of two weeks of reduced activity on muscle strength and size, and any effect on how muscle is re-gained afterwards, will be compared to the 'control' group.
Read the detailed description
Overall study design:
This study will be structured as a randomised control trial with two exercise treatment groups and one 'control' group. All three groups will undergo 14-days of reduced activity by restricting daily walking to less than 1,500 steps. One group will undertake four weeks of resistance exercise pre-training immediately prior to the 14-day step-reduction (PT group), and another group will undertake short bouts of home-based exercise (exercise snacking) every day during the 14-day step-reduction (ES group). The control group will undertake the 14-day step-reduction with neither exercise strategy. All three groups will then undertake two weeks of laboratory based resistance exercise training immediately after the step-reduction period, and will be offered a further six weeks of gym based personal training, and a six month gym and swimming pool membership at the Team Bath Sports Training Village.
Following advertisement of the study, interested potential participants will be asked to contact the chief investigator for further information via telephone or email correspondence. Further details including inclusion criteria will be provided verbally, and a full participant information sheet will be sent to potential participants that feel that they meet the inclusion criteria. If the potential participant chooses to be considered for inclusion in the trial, they must sign the consent form for initial screening and will be invited to a medical screening meeting with a member of the research team.
Preliminary assessment:
All potential participants will undergo screening to assess eligibility for inclusion before proceeding. This will include an objective assessment of physical function (Short Physical Performance Battery) in which simple tests of walking speed, ability to repeatedly rise from a chair, and simple standing balance are scored based on set criteria. Only participants scoring over 7 out of 12 will be eligible to participate. Participants will wear a step-counter (pedometer), and a physical activity monitor (BodyMedia armband) for one week, and be asked to record all food and drink consumed for three days (including one weekend day) using a provided diet record sheet. Only individuals who average 3,500 steps per day or above will be included in the study. At the end of this monitoring period, eligible participants will be asked to sign a consent form for the main study, and will be randomly assigned to an experimental group by minimisation.
Familiarisation with strength, power, and balance assessment:
Eligible participants will be invited to the laboratory for two familiarisation sessions with the muscle strength, balance, and neural drive testing tools. Participants will be asked to wear light clothes in which it is comfortable to perform exercise. These familiarisation sessions will be at least five but less 14 days apart, with the second session at least five days before the start of the pre-training for the PT group, and at least five but less than 14 days before the pre-step-reduction main trial.
Pre-training group:
Participants in the PT group will be asked to undergo baseline assessments of muscle function (including one-repetition maximum (1RM) strength tests to set the load for subsequent training sessions), body composition, muscle size, and muscle fibre pennation to monitor the effectiveness of the pre-training exercise intervention on the day of the second familiarisation session.
Participants in the PT group will attend ten resistance training sessions across four weeks prior to the 14-day step-reduction, with sessions separated by at least 48 hours. The last training session will take place three days before the first main trial pre-step-reduction. All exercise sessions will be fully supervised by a member of the research team. At the beginning of the fifth session, participants will repeat the 1RM and incremental power tests. Repetitions will be performed at a cadence of 1:1 for extension:flexion time, at a participant-selected pace less that should be less than five seconds per complete repetition. Rest intervals between sets will be 90 to 120 seconds at the participant's discretion.
Participants will complete the standardised warm-up on the Keiser leg press performed during the familiarisation session, using the most recent 1RM. All exercise sessions will include leg press and leg extension exercises, followed by either dumbbell calf raises, and dumbbell curl and press, or dumbbell lateral raises, and seated lateral pull down with resistance bands.
Main Trials taking place on the day before and day after the two-week step-reduction:
Participants will be asked to report to the laboratory after a 10-hour overnight fast wearing light clothing with no metal components. Measures of the participant's height, weight, and waist circumference will be determined. Body composition will be assessed using a whole body dual-energy X-ray absorptiometry scan (DEXA), and a peripheral quantitative computed tomography scan (pQCT) of the calf and thigh, and an ultrasound scan of the calf and thigh will be conducted. The pQCT and ultrasound will be taken from the dominant leg. Resting samples of subcutaneous adipose tissue via biopsy techniques and venous blood via cannula will then be obtained. Participants will ingest 200 ml of D20 and undertake a mixed meal tolerance test whilst remaining rested in a comfortable bed or armchair for three hours with blood samples drawn intermittently through the cannula. A short lunch break will then be taken. Thereafter a thigh muscle biopsy will be sampled, and then participants will undertake balance testing as performed in the familiarisation, whilst wearing Xsens 3D accelerometers on the foot, shin, and thigh with adhesive pads and being filmed with two video cameras to record footage for later kinematic analysis. The standard leg pressing warm-up using the previously obtained 1-RM, and the incremental power test described above as a measure of leg strength and power will then be performed. Following two minutes of recovery, participants will complete the assessment of neural drive of the calf muscle, followed by three sets of eight repetitions at 70% 1RM on the leg press and leg extension (total of 48 repetitions). This protocol is used to stimulate the stress response to exercise, so blood samples will be taken immediately after the exercise is complete with a muscle biopsy obtained from the contralateral leg after 90-minutes of seated rest post exercise. Whilst the participant rests, they will be asked to complete two questionnaires (The Pittsburgh Sleep Quality Index, and World Health Organization Quality of Life questionnaire (WHOQOL-BREF)). Participants in the ES group will then be given a demonstration of the exercise snacking regime, and be asked to complete a bout of the exercise, and shown how to use their exercise snacking log book.
Step-reduction:
For the next 14-days participants will be asked to restrict their daily step count to no more than 1500 steps per day. A portable pedometer will be worn by subjects at all times throughout the day (excluding sleep) to allow accurate monitoring and feedback of step count. Participants in the ES group will be asked to record number of steps before and after each bout of exercise snacking exercise thus steps taken during the exercise snack can be excluded from the daily 1,500 steps limit. Participants will also wear a physical activity monitor throughout the first week of the intervention. They will be asked to record their dietary intake on the 1st, 7th and 13th days of the step-reduction intervention using a dietary diary.
Other assessments:
Biopsy 1: On the third day of the 14-day step-reduction, a resting muscle biopsy and blood sample will be taken. Transport arrangements will be made to reduce ambulation for the purpose of the visit. Participants in the ES group will be asked to perform an exercise snack in the laboratory.
Biopsy 2: On the eighth day of the 14-day step-reduction, another muscle biopsy and blood sample will be taken, and 100 ml dose of D20 ingested.
Follow up biopsy: Three days after the 14-day step-reduction, a final muscle biopsy and blood sample will be taken.
Exercise Snacking regime:
The exercise snacking requires only a stable kitchen chair to perform, and no supervision is necessary though three bouts will be performed in the laboratory. Participants will be asked to perform five exercises, each for one minute followed by one minute of rest. In that minute of exercise, the participant will perform as many controlled repetitions of the exercise as they can. Participants will be asked to perform the exercise snacks three times daily, separated by at least two hours where possible. The exercises are: sit-to-stand from a chair, seated knee extension, standing knee bends, marching on the spot, and standing calf raises. A chair can be held for stability if needed. Participants will always perform the sit-to-stand exercise first, and record the number of repetitions completed in the minute, and thereafter participants may alternate the order of exercises, but will be asked to record the order in a log book provided.
Re-training:
After the step-reduction participants will attend six resistance training sessions over 14-days with sessions separated by at least 48 hours, with the first training session taking place on the day of the follow up biopsy once the sample has been taken. These sessions will take place in the laboratory, supervised by a member of the research team, and will follow the same training regime as the PT group undertook prior to commencing the step-reduction. Thereafter, participants will be offered six weeks of further re-training supervised by a qualified personal trainer, training two times per week in the University Sports Training Village.
Post re-training muscle size, strength, power, and balance assessments:
Follow-up assessments of muscle function, balance, and muscle size and architecture will be made two days after the final session of the two-week laboratory based re-training, and where applicable two-days after the optional six-week gym based re-training (optional). These assessments will be DEXA, pQCT and ultrasound scans, and the leg press incremental power test, test of neural drive, and balance and movement pattern assessments.
Qualitative assessment of well-being and quality of life:
Following or during the intervention each participant will be invited to take part in an interview to provide feedback on his experience during the trial. Participants will be provided with written information of the purpose of the interviews (i.e., to inform the feasibility of the protocols) and reassured that participation is optional. Interviews will take place via telephone or in person according to participant preference, will be digitally recorded, transcribed verbatim and anonymized on completion. The interview schedule will cover; (i) participants' perceptions of the impact of inactivity on mood, appetite, vitality, sleep and other participant-generated concerns (for comparison across conditions), (ii) adherence to the study protocol (i.e., if and how participants adapted the prescribed regimes, and factors they suggest would make the protocol easier to adopt), and (iii) participants in the exercise snacking condition will additionally be asked to discuss the perceived barriers and facilitators, and costs and benefits of exercise-snacking. Transcripts will be analysed systematically using framework analysis to highlight key themes within and across participants, and the results used to facilitate participant input into the feasibility analysis and protocol amendments.
- Conditions
- Muscular Atrophy
- Being tested
- Step-reduction, Pre-training, Exercise snacking
- Keywords
- Step-reduction model, Reduced activity, Atrophy, Skeletal Muscle, Sarcopenia, Dynapenia
- Medical subject headings
- Muscular Atrophy, Atrophy, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step-reductionBehavioural
Also called Reduced physical activity
Participants will reduce the number of steps they take each day to less than 1, 500 for two weeks, using a pedometer to monitor their daily step count.
Pre-trainingBehavioural
Participants will attend 10 strength training exercise sessions over a four week period prior to the step-reduction intervention. These exercise sessions will be focused on lower limb strength, fully supervised and will be progressive.
Exercise snackingBehavioural
Participants will perform three bouts of five minutes of exercise each day during the two week step-reduction intervention. These will consist of five discrete exercises, each performed continuously for one minute, with one minute of rest between each exercise. These exercises will be non-supervised, and require no specialist equipment.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | This group will undertake two-weeks of step-reduction to <1,500 steps per day, followed by two-weeks of strength training exercise (6 sessions). Receives: Behavioral: Step-reduction |
| Pre-Training Group | Experimental | This group will undertake four weeks of strength training exercise (10 sessions) before two-weeks of step-reduction to <1,500 steps per day, followed by two-weeks of strength training exercise (6 sessions). Receives: Behavioral: Step-reduction; Behavioral: Pre-training |
| Exercise Snacking Group | Experimental | This group will undertake home-based 'exercise snacks' of simple lower limb movement (5 minutes, 3 times a day) whilst undertaking two-weeks of step-reduction to <1,500 steps per day, followed by two-weeks of strength training exercise (6 sessions). Receives: Behavioral: Step-reduction; Behavioral: Exercise snacking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower limb muscle power
Measured during leg pressing
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Secondary outcomes (48)
Lower limb muscle power
Measured during leg pressing
Measured: Two weeks- Change from post-step-reduction intervention to post-re-training intervention
Lower limb muscle power
For the Pre-training group only: measured during leg pressing
Measured: Four weeks- Change from pre-pre-training intervention to 'baseline' pre-step-reduction intervention
Lower limb muscle force
Measured during leg pressing
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Lower limb muscle force
Measured during leg pressing
Measured: Two weeks- Change from post-step-reduction intervention to post-re-training intervention
Lower limb muscle force
For the Pre-training group only: measured during leg pressing
Measured: Four weeks- Change from pre-pre-training intervention to 'baseline' pre-step-reduction intervention
Lower limb muscle velocity
Measured during leg pressing
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Lower limb muscle velocity
Measured during leg pressing
Measured: Two weeks- Change from post-step-reduction intervention to post-re-training intervention
Lower limb muscle velocity
For the Pre-training group only: measured during leg pressing
Measured: Four weeks- Change from pre-pre-training intervention to 'baseline' pre-step-reduction intervention
Postural sway during standing balance with eyes open and closed
Measured using a force plate
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Postural sway during standing balance with eyes open and closed
Measured using a force plate
Measured: Two weeks- Change from post-step-reduction intervention to post-re-training intervention
Postural sway during standing balance with eyes open and closed
For the Pre-training group only: measured using a force plate
Measured: Four weeks- Change from pre-pre-training intervention to 'baseline' pre-step-reduction intervention
Single leg balance
Measured using the Y-balance test
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Single leg balance
Measured using the Y-balance test
Measured: Two weeks- Change from post-step-reduction intervention to post-re-training intervention
Single leg balance
For the Pre-training group only: measured using the Y-Balance test
Measured: Four weeks- Change from pre-pre-training intervention to 'baseline' pre-step-reduction intervention
Lower limb movement variability
Measured using X-Sens inertial measurement units placed on the lower limb during walking and the Y-balance test
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Lower limb movement variability
Measured using X-Sens inertial measurement units placed on the lower limb during walking and the Y-balance test
Measured: Two weeks- Change from post-step-reduction intervention to post-re-training intervention
Lower limb movement variability
For the Pre-training group only: measured using X-Sens inertial measurement units placed on the lower limb during walking and the Y-balance test
Measured: Four weeks- Change from pre-pre-training intervention to 'baseline' pre-step-reduction intervention
Body composition
Measured using Dual Energy X-ray Absorptiometry
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Body composition
Measured using Dual Energy X-ray Absorptiometry
Measured: Two weeks- Change from post-step-reduction intervention to post-re-training intervention
Body composition
For the Pre-training group only: measured using Dual Energy X-ray Absorptiometry
Measured: Four weeks- Change from pre-pre-training intervention to 'baseline' pre-step-reduction intervention
Lower limb muscle cross-sectional area and tissue density
Measured using peripheral quantitative computed tomography at 66% distal calf length and 25% and 50% distal thigh length
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Lower limb muscle cross-sectional area and tissue density
Measured using peripheral quantitative computed tomography at 66% distal calf length and 25% and 50% distal thigh length
Measured: Two weeks- Change from post-step-reduction intervention to post-re-training intervention
Lower limb muscle cross-sectional area and tissue density
For the Pre-training group only: measured using peripheral quantitative computed tomography at 66% distal calf length and 25% and 50% distal thigh length
Measured: Four weeks- Change from pre-pre-training intervention to 'baseline' pre-step-reduction intervention
Gastrocnemius and quadriceps muscle fibre pennation angle
Measured using ultrasonography at 66% distal length of calf length and 50% distal thigh length
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Gastrocnemius and quadriceps muscle fibre pennation angle
Measured using ultrasonography at 66% distal length of calf length and 50% distal thigh length
Measured: Two weeks- Change from post-step-reduction intervention to post-re-training intervention
Gastrocnemius and quadriceps muscle fibre pennation angle
For the Pre-training group only: measured using ultrasonography at 66% distal length of calf length and 50% distal thigh length
Measured: Four weeks- Change from pre-pre-training intervention to 'baseline' pre-step-reduction intervention
Rates of free-living muscle protein synthesis assessed by stable isotope tracer deuterium oxide (D2O) incorporation rate
Measured by pyrolysis gas chromatography-mass spectrometry
Measured: 3, 8, 15, and 18 days- Change in rate of incorporation from baseline to 3 days post-step-reduction intervention
Free-living adipose triglyceride incorporation assessed by D2O incorporation
Measured by gas chromatography-mass spectrometry
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Total and phosphorylated muscle protein synthesis and breakdown signalling proteins after exercise
Specific signalling proteins to be measured by Western Blotting: Protein kinase B (AKT), mammalian target of rapamycin (mTOR), p70S6 Kinases (p70S6K), 4EBP-1, Muscle RING-finger protein-1 (MuRF-1), muscle atrophy F-box (MAFbx), Forkhead box O (FOXO)
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Messenger Ribonucleic acid (mRMA) expression of muscle protein synthesis and breakdown signalling proteins
Specific signalling proteins to be measured by quantitative polymerase chain reaction: AKT, mTOR, p70S6K, 4EBP-1, MuRF-1, MAFbx, FOXO
Measured: Two weeks- Change from baseline to post-step-reduction intervention
nicotinamide adenine dinucleotide phosphate-oxidase (NAD(P)H oxidase) production in response to strenuous exercise
Measured by colourimetric assay
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Aconitase activity in response to strenuous exercise
Measured by Aconitase assay
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Hydrogen peroxide production in response to strenuous exercise
Measured by Amplex Red assay
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Heat Shock Protein 27 muscle content in response to strenuous exercise
Measured by enzyme linked immunosorbent assay
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Inflammation and oxidative stress response transcription factor activation in response to strenuous exercise
Measured by enzyme linked immunosorbent assay
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Subcutaneous adipose tissue cytokine secretion at rest
Specifically leptin, adiponectin, Interleukin (IL)-6, Tumour necrosis factor alpha (TNFa), IL-8, and IL-1ra will be measured using enzyme linked immunosorbent assay
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Systemic cytokines at rest
Specifically IL-6, TNFa, and C-reactive protein (CRP) will be measured using enzyme linked immunosorbent assay (ELISA)
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Cytotoxic "killer" T lymphocyte interferon-gamma production in response to proteins from common viruses
Measured by Enzyme-Linked ImmunoSpot (ELIspot) assay, specifically response to proteins from Epstein Barr Virus, Cytomegalovirus, Herpes Simplex Virus 1 and 2, Adenovirus, Varicella Zoster Virus and Influenza Virus will be measure
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Postprandial blood insulin concentration
Measured by mixed meal tolerance test of 2 g/kg body mass (BM) carbohydrate; 0.8 g/kg BM fat; 0.4 g/kg BM protein
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Postprandial blood glucose concentration
Measured by mixed meal tolerance test of 2 g/kg body mass (BM) carbohydrate; 0.8 g/kg BM fat; 0.4 g/kg BM protein
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Postprandial blood triglyceride concentration
Measured by mixed meal tolerance test of 2 g/kg body mass (BM) carbohydrate; 0.8 g/kg BM fat; 0.4 g/kg BM protein
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Postprandial blood high-density lipoprotein concentration
Measured by mixed meal tolerance test of 2 g/kg body mass (BM) carbohydrate; 0.8 g/kg BM fat; 0.4 g/kg BM protein
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Postprandial blood low-density lipoprotein concentration
Measured by mixed meal tolerance test of 2 g/kg body mass (BM) carbohydrate; 0.8 g/kg BM fat; 0.4 g/kg BM protein
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Postprandial blood non-esterified fatty acid concentration
Measured by mixed meal tolerance test of 2 g/kg body mass (BM) carbohydrate; 0.8 g/kg BM fat; 0.4 g/kg BM protein
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Dietary intake
Measured with 3-day food diary record sheets to obtain total daily calories consumed and macronutrient profile
Measured: Approximately 4 or 8 weeks- Change from preliminary screening period to during step-reduction intervention
Sleep quality
Measured with the Pittsburgh Sleep Quality Index questionnaire
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Quality of life
Measured with the WHOQOL-BREF questionnaire
Measured: Two weeks- Change from baseline to post-step-reduction intervention
Qualitative feedback of participant experience of the interventions
Measured with phone or face to face qualitative interview
Measured: Less than 6 weeks post-re-training intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscular AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr Oliver Perkin, University of Bath
- Investigators
- Keith Stokes, PhD, Principal investigator, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495727
- Sponsor's protocol ID
- UoB-SRS-01
- Status last verified
- May 2018
- First submitted
- 25 Jun 2015
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Breen L, Stokes KA, Churchward-Venne TA, Moore DR, Baker SK, Smith K, Atherton PJ, Phillips SM. Two weeks of reduced activity decreases leg lean mass and induces "anabolic resistance" of myofibrillar protein synthesis in healthy elderly. J Clin Endocrinol Metab. 2013 Jun;98(6):2604-12. doi: 10.1210/jc.2013-1502. Epub 2013 Apr 15.
PubMed 23589526Perkin OJ, Travers RL, Gonzalez JT, Turner JE, Gillison F, Wilson C, McGuigan PM, Thompson D, Stokes KA. Exercise strategies to protect against the impact of short-term reduced physical activity on muscle function and markers of health in older men: study protocol for a randomised controlled trial. Trials. 2016 Aug 2;17:381. doi: 10.1186/s13063-016-1440-z.
PubMed 27484001
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 14-days of Reduced Physical Activity on Muscle Function and Size, Inflammatory Profile, and Exercise-induced Activation of Stress Responses in Skeletal Muscle in Healthy Older Males
- ClinicalTrials.gov ID
- NCT02495727
- Acronym / sponsor ID
- UoB-SRS-01
- Conditions
- Muscular Atrophy
- Keywords
- Step-reduction model, Reduced activity, Atrophy, Skeletal Muscle, Sarcopenia, Dynapenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 13 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Muscle size declines at around 0.5-1% per year after 50 years of age, with muscle strength declining up to twice as fast as muscle size. This may eventually lead to loss of independence if tasks of daily living become too strenuous to be performed safely. Short periods of bed rest cause very rapid loss of muscle size and strength, and studies using healthy older participants have shown that age increases vulnerability to this muscle loss. However, it is unlikely that healthy individuals would be faced with periods of bed rest unless suffering a severe illness. In light of this, recent evidence has shown that even just reducing walking to less than 1,500 steps per day for two weeks caused 4% loss of leg muscle in over 65 year olds. This amount of activity is roughly the equivalent of being housebound, something that may become more common into older age, for example due to prolonged bad weather, or minor injury or illness.
This study will investigate what causes such stark muscle loss during two weeks of reduced activity, and the impact on skeletal muscle function and size, as well as balance, body composition, and other indicators of general health such as how the body responds to food or exercise. Importantly, exercise strategies that could reduce muscle loss during a period of reduced activity will also be investigated.
In brief, three groups of 10 older men (aged 65-80 years) will undertake two weeks of reduced physical activity by limiting their daily steps to <1,500/day. All groups will then undertake a re-training exercise programme to ensure that any losses in muscle strength or size are regained. One of the groups will be a control, whereby they will undertake the step-reduction intervention and re-training, but no protective exercise before or during the step-reduction intervention. This group will allow us to achieve our primary objective of determining the influence of two weeks of reduced physical activity on muscle strength and size in healthy older males. The two other groups will undertake either four weeks of strength exercise training before the step-reduction intervention, or daily home based exercise 'snacking' during the step-reduction intervention. The potential protective benefits of the exercise interventions in reducing the impact of two weeks of reduced activity on muscle strength and size, and any effect on how muscle is re-gained afterwards, will be compared to the 'control' group.
Detailed description
Overall study design:
This study will be structured as a randomised control trial with two exercise treatment groups and one 'control' group. All three groups will undergo 14-days of reduced activity by restricting daily walking to less than 1,500 steps. One group will undertake four weeks of resistance exercise pre-training immediately prior to the 14-day step-reduction (PT group), and another group will undertake short bouts of home-based exercise (exercise snacking) every day during the 14-day step-reduction (ES group). The control group will undertake the 14-day step-reduction with neither exercise strategy. All three groups will then undertake two weeks of laboratory based resistance exercise training immediately after the step-reduction period, and will be offered a further six weeks of gym based personal training, and a six month gym and swimming pool membership at the Team Bath Sports Training Village.
Following advertisement of the study, interested potential participants will be asked to contact the chief investigator for further information via telephone or email correspondence. Further details including inclusion criteria will be provided verbally, and a full participant information sheet will be sent to potential participants that feel that they meet the inclusion criteria. If the potential participant chooses to be considered for inclusion in the trial, they must sign the consent form for initial screening and will be invited to a medical screening meeting with a member of the research team.
Preliminary assessment:
All potential participants will undergo screening to assess eligibility for inclusion before proceeding. This will include an objective assessment of physical function (Short Physical Performance Battery) in which simple tests of walking speed, ability to repeatedly rise from a chair, and simple standing balance are scored based on set criteria. Only participants scoring over 7 out of 12 will be eligible to participate. Participants will wear a step-counter (pedometer), and a physical activity monitor (BodyMedia armband) for one week, and be asked to record all food and drink consumed for three days (including one weekend day) using a provided diet record sheet. Only individuals who average 3,500 steps per day or above will be included in the study. At the end of this monitoring period, eligible participants will be asked to sign a consent form for the main study, and will be randomly assigned to an experimental group by minimisation.
Familiarisation with strength, power, and balance assessment:
Eligible participants will be invited to the laboratory for two familiarisation sessions with the muscle strength, balance, and neural drive testing tools. Participants will be asked to wear light clothes in which it is comfortable to perform exercise. These familiarisation sessions will be at least five but less 14 days apart, with the second session at least five days before the start of the pre-training for the PT group, and at least five but less than 14 days before the pre-step-reduction main trial.
Pre-training group:
Participants in the PT group will be asked to undergo baseline assessments of muscle function (including one-repetition maximum (1RM) strength tests to set the load for subsequent training sessions), body composition, muscle size, and muscle fibre pennation to monitor the effectiveness of the pre-training exercise intervention on the day of the second familiarisation session.
Participants in the PT group will attend ten resistance training sessions across four weeks prior to the 14-day step-reduction, with sessions separated by at least 48 hours. The last training session will take place three days before the first main trial pre-step-reduction. All exercise sessions will be fully supervised by a member of the research team. At the beginning of the fifth session, participants will repeat the 1RM and incremental power tests. Repetitions will be performed at a cadence of 1:1 for extension:flexion time, at a participant-selected pace less that should be less than five seconds per complete repetition. Rest intervals between sets will be 90 to 120 seconds at the participant's discretion.
Participants will complete the standardised warm-up on the Keiser leg press performed during the familiarisation session, using the most recent 1RM. All exercise sessions will include leg press and leg extension exercises, followed by either dumbbell calf raises, and dumbbell curl and press, or dumbbell lateral raises, and seated lateral pull down with resistance bands.
Main Trials taking place on the day before and day after the two-week step-reduction:
Participants will be asked to report to the laboratory after a 10-hour overnight fast wearing light clothing with no metal components. Measures of the participant's height, weight, and waist circumference will be determined. Body composition will be assessed using a whole body dual-energy X-ray absorptiometry scan (DEXA), and a peripheral quantitative computed tomography scan (pQCT) of the calf and thigh, and an ultrasound scan of the calf and thigh will be conducted. The pQCT and ultrasound will be taken from the dominant leg. Resting samples of subcutaneous adipose tissue via biopsy techniques and venous blood via cannula will then be obtained. Participants will ingest 200 ml of D20 and undertake a mixed meal tolerance test whilst remaining rested in a comfortable bed or armchair for three hours with blood samples drawn intermittently through the cannula. A short lunch break will then be taken. Thereafter a thigh muscle biopsy will be sampled, and then participants will undertake balance testing as performed in the familiarisation, whilst wearing Xsens 3D accelerometers on the foot, shin, and thigh with adhesive pads and being filmed with two video cameras to record footage for later kinematic analysis. The standard leg pressing warm-up using the previously obtained 1-RM, and the incremental power test described above as a measure of leg strength and power will then be performed. Following two minutes of recovery, participants will complete the assessment of neural drive of the calf muscle, followed by three sets of eight repetitions at 70% 1RM on the leg press and leg extension (total of 48 repetitions). This protocol is used to stimulate the stress response to exercise, so blood samples will be taken immediately after the exercise is complete with a muscle biopsy obtained from the contralateral leg after 90-minutes of seated rest post exercise. Whilst the participant rests, they will be asked to complete two questionnaires (The Pittsburgh Sleep Quality Index, and World Health Organization Quality of Life questionnaire (WHOQOL-BREF)). Participants in the ES group will then be given a demonstration of the exercise snacking regime, and be asked to complete a bout of the exercise, and shown how to use their exercise snacking log book.
Step-reduction:
For the next 14-days participants will be asked to restrict their daily step count to no more than 1500 steps per day. A portable pedometer will be worn by subjects at all times throughout the day (excluding sleep) to allow accurate monitoring and feedback of step count. Participants in the ES group will be asked to record number of steps before and after each bout of exercise snacking exercise thus steps taken during the exercise snack can be excluded from the daily 1,500 steps limit. Participants will also wear a physical activity monitor throughout the first week of the intervention. They will be asked to record their dietary intake on the 1st, 7th and 13th days of the step-reduction intervention using a dietary diary.
Other assessments:
Biopsy 1: On the third day of the 14-day step-reduction, a resting muscle biopsy and blood sample will be taken. Transport arrangements will be made to reduce ambulation for the purpose of the visit. Participants in the ES group will be asked to perform an exercise snack in the laboratory.
Biopsy 2: On the eighth day of the 14-day step-reduction, another muscle biopsy and blood sample will be taken, and 100 ml dose of D20 ingested.
Follow up biopsy: Three days after the 14-day step-reduction, a final muscle biopsy and blood sample will be taken.
Exercise Snacking regime:
The exercise snacking requires only a stable kitchen chair to perform, and no supervision is necessary though three bouts will be performed in the laboratory. Participants will be asked to perform five exercises, each for one minute followed by one minute of rest. In that minute of exercise, the participant will perform as many controlled repetitions of the exercise as they can. Participants will be asked to perform the exercise snacks three times daily, separated by at least two hours where possible. The exercises are: sit-to-stand from a chair, seated knee extension, standing knee bends, marching on the spot, and standing calf raises. A chair can be held for stability if needed. Participants will always perform the sit-to-stand exercise first, and record the number of repetitions completed in the minute, and thereafter participants may alternate the order of exercises, but will be asked to record the order in a log book provided.
Re-training:
After the step-reduction participants will attend six resistance training sessions over 14-days with sessions separated by at least 48 hours, with the first training session taking place on the day of the follow up biopsy once the sample has been taken. These sessions will take place in the laboratory, supervised by a member of the research team, and will follow the same training regime as the PT group undertook prior to commencing the step-reduction. Thereafter, participants will be offered six weeks of further re-training supervised by a qualified personal trainer, training two times per week in the University Sports Training Village.
Post re-training muscle size, strength, power, and balance assessments:
Follow-up assessments of muscle function, balance, and muscle size and architecture will be made two days after the final session of the two-week laboratory based re-training, and where applicable two-days after the optional six-week gym based re-training (optional). These assessments will be DEXA, pQCT and ultrasound scans, and the leg press incremental power test, test of neural drive, and balance and movement pattern assessments.
Qualitative assessment of well-being and quality of life:
Following or during the intervention each participant will be invited to take part in an interview to provide feedback on his experience during the trial. Participants will be provided with written information of the purpose of the interviews (i.e., to inform the feasibility of the protocols) and reassured that participation is optional. Interviews will take place via telephone or in person according to participant preference, will be digitally recorded, transcribed verbatim and anonymized on completion. The interview schedule will cover; (i) participants' perceptions of the impact of inactivity on mood, appetite, vitality, sleep and other participant-generated concerns (for comparison across conditions), (ii) adherence to the study protocol (i.e., if and how participants adapted the prescribed regimes, and factors they suggest would make the protocol easier to adopt), and (iii) participants in the exercise snacking condition will additionally be asked to discuss the perceived barriers and facilitators, and costs and benefits of exercise-snacking. Transcripts will be analysed systematically using framework analysis to highlight key themes within and across participants, and the results used to facilitate participant input into the feasibility analysis and protocol amendments.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Behavioral: Step-reductionThis group will undertake two-weeks of step-reduction to <1,500 steps per day, followed by two-weeks of strength training exercise (6 sessions). |
| Pre-Training Group | Experimental | Behavioral: Step-reduction, Behavioral: Pre-trainingThis group will undertake four weeks of strength training exercise (10 sessions) before two-weeks of step-reduction to <1,500 steps per day, followed by two-weeks of strength training exercise (6 sessions). |
| Exercise Snacking Group | Experimental | Behavioral: Step-reduction, Behavioral: Exercise snackingThis group will undertake home-based 'exercise snacks' of simple lower limb movement (5 minutes, 3 times a day) whilst undertaking two-weeks of step-reduction to <1,500 steps per day, followed by two-weeks of strength training exercise (6 sessions). |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged 65 to 80 years
- Not underweight or obese (body mass index ≥20 and ≤ 30 kg/m2)
- Non-smoker (for >5 years)
- Healthy (see exclusion criteria)
Key exclusion criteria (9 listed)
- Any chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, peripheral arterial disease, insulin- or non-insulin dependent diabetes or other metabolic disorders - all ascertained through medical screening.
- Individuals who consume on a daily basis any analgesic or anti-inflammatory drug(s), prescription or non-prescription will be excluded.
- Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).
- Individuals with a history of bone, joint or neuromuscular problems or a current musculoskeletal injury ascertained through medical screening.
- Individuals with a known bleeding disorder, on the anticoagulant drug Warfarin, or prone to keloid scarring.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step-reductionAlso: Reduced physical activityParticipants will reduce the number of steps they take each day to less than 1, 500 for two weeks, using a pedometer to monitor their daily step count. | Behavioural | Control Group, Exercise Snacking Group, Pre-Training Group |
| Pre-trainingParticipants will attend 10 strength training exercise sessions over a four week period prior to the step-reduction intervention. These exercise sessions will be focused on lower limb strength, fully supervised and will be progressive. | Behavioural | Pre-Training Group |
| Exercise snackingParticipants will perform three bouts of five minutes of exercise each day during the two week step-reduction intervention. These will consist of five discrete exercises, each performed continuously for one minute, with one minute of rest between each exercise. These exercises will be non-supervised, and require no specialist equipment. | Behavioural | Exercise Snacking Group |
Primary outcome
Lower limb muscle power
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
Measured during leg pressing
48 secondary outcomes
Lower limb muscle power
Time frame: Two weeks- Change from post-step-reduction intervention to post-re-training intervention
Lower limb muscle power
Time frame: Four weeks- Change from pre-pre-training intervention to 'baseline' pre-step-reduction intervention
Lower limb muscle force
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
Lower limb muscle force
Time frame: Two weeks- Change from post-step-reduction intervention to post-re-training intervention
Lower limb muscle force
Time frame: Four weeks- Change from pre-pre-training intervention to 'baseline' pre-step-reduction intervention
Lower limb muscle velocity
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
Lower limb muscle velocity
Time frame: Two weeks- Change from post-step-reduction intervention to post-re-training intervention
Lower limb muscle velocity
Time frame: Four weeks- Change from pre-pre-training intervention to 'baseline' pre-step-reduction intervention
Postural sway during standing balance with eyes open and closed
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
Postural sway during standing balance with eyes open and closed
Time frame: Two weeks- Change from post-step-reduction intervention to post-re-training intervention
Postural sway during standing balance with eyes open and closed
Time frame: Four weeks- Change from pre-pre-training intervention to 'baseline' pre-step-reduction intervention
Single leg balance
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
Single leg balance
Time frame: Two weeks- Change from post-step-reduction intervention to post-re-training intervention
Single leg balance
Time frame: Four weeks- Change from pre-pre-training intervention to 'baseline' pre-step-reduction intervention
Lower limb movement variability
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
Lower limb movement variability
Time frame: Two weeks- Change from post-step-reduction intervention to post-re-training intervention
Lower limb movement variability
Time frame: Four weeks- Change from pre-pre-training intervention to 'baseline' pre-step-reduction intervention
Body composition
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
Body composition
Time frame: Two weeks- Change from post-step-reduction intervention to post-re-training intervention
Body composition
Time frame: Four weeks- Change from pre-pre-training intervention to 'baseline' pre-step-reduction intervention
Lower limb muscle cross-sectional area and tissue density
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
Lower limb muscle cross-sectional area and tissue density
Time frame: Two weeks- Change from post-step-reduction intervention to post-re-training intervention
Lower limb muscle cross-sectional area and tissue density
Time frame: Four weeks- Change from pre-pre-training intervention to 'baseline' pre-step-reduction intervention
Gastrocnemius and quadriceps muscle fibre pennation angle
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
Gastrocnemius and quadriceps muscle fibre pennation angle
Time frame: Two weeks- Change from post-step-reduction intervention to post-re-training intervention
Gastrocnemius and quadriceps muscle fibre pennation angle
Time frame: Four weeks- Change from pre-pre-training intervention to 'baseline' pre-step-reduction intervention
Rates of free-living muscle protein synthesis assessed by stable isotope tracer deuterium oxide (D2O) incorporation rate
Time frame: 3, 8, 15, and 18 days- Change in rate of incorporation from baseline to 3 days post-step-reduction intervention
Free-living adipose triglyceride incorporation assessed by D2O incorporation
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
Total and phosphorylated muscle protein synthesis and breakdown signalling proteins after exercise
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
Messenger Ribonucleic acid (mRMA) expression of muscle protein synthesis and breakdown signalling proteins
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
nicotinamide adenine dinucleotide phosphate-oxidase (NAD(P)H oxidase) production in response to strenuous exercise
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
Aconitase activity in response to strenuous exercise
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
Hydrogen peroxide production in response to strenuous exercise
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
Heat Shock Protein 27 muscle content in response to strenuous exercise
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
Inflammation and oxidative stress response transcription factor activation in response to strenuous exercise
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
Subcutaneous adipose tissue cytokine secretion at rest
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
Systemic cytokines at rest
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
Cytotoxic "killer" T lymphocyte interferon-gamma production in response to proteins from common viruses
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
Postprandial blood insulin concentration
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
Postprandial blood glucose concentration
Time frame: Two weeks- Change from baseline to post-step-reduction intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
- Background: PubMed 23589526Breen L, Stokes KA, Churchward-Venne TA, Moore DR, Baker SK, Smith K, Atherton PJ, Phillips SM. Two weeks of reduced activity decreases leg lean mass and induces "anabolic resistance" of myofibrillar protein synthesis in healthy elderly. J Clin Endocrinol Metab. 2013 Jun;98(6):2604-12. doi: 10.1210/jc.2013-1502. Epub 2013 Apr 15.
- Derived from this study: PubMed 27484001Perkin OJ, Travers RL, Gonzalez JT, Turner JE, Gillison F, Wilson C, McGuigan PM, Thompson D, Stokes KA. Exercise strategies to protect against the impact of short-term reduced physical activity on muscle function and markers of health in older men: study protocol for a randomised controlled trial. Trials. 2016 Aug 2;17:381. doi: 10.1186/s13063-016-1440-z.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Stokes, PhD principal investigator
University of Bath
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step-reduction, Pre-training and Exercise snacking in people with Muscular Atrophy, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower limb muscle power (time frame: Two weeks- Change from baseline to post-step-reduction intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02495727, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2018.