Muscle DegenerationENDURENCT04997447
Enforced Reduction in Physical Activity and Recovery in Older Adults
A study testing Step-reduction/Exercise Rehab in people with Muscle Degeneration and Body Weight Changes, run by University of Jyvaskyla at 1 site in Finland.
Trial summary
Apparently healthy and well-functioning community dwelling 70-80 year-olds will be recruited to the study. All subjects undergo pre-screening for suitability and a physicians examination, as well as 7-day habitual daily steps are measured to ascertain baseline physical activity. Read more about this study
- Who is it for?
- Ages 70 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Degeneration, Body Weight Changes, Walking, Difficulty
- What is being tested?
- Step-reduction/Exercise Rehab
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFinland
- Study dates
- 15 Sep 2021to 22 Nov 2022
- 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 70 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- aged 70-80 years,
- community-dwelling,
- able to walk 500 m without assistance or use of walking aid and regularly walking >5000 steps per day,
- MMSE >24,
- BMI 20-35 kg·m2 (i.e. not underweight or severely obese),
- no serious cardiovascular or musculoskeletal disease,
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- no risk factors for deep-vein thrombosis (e.g. blood clotting disorder, obesity, bowel diseases, personal or family history of DVT etc.),
- non-smoker,
- provision of informed consent.
Who cannot join
- Underlying diseases likely to limit lifespan and/or intervention safety. Contraindication for physical exercise or physical tests identified during physician's examination,
- unwilling/unable to track daily step counts using accelerometer,
- excessive and regular use of alcohol (more than 7 units per week for women and 14 for men)
- difficulty in communication due to severe vision or hearing problems
- unwilling to provide consent or accept randomization into either study group
Trial locations and contacts
1 site in 1 country.
About this study
Apparently healthy and well-functioning community dwelling 70-80 year-olds will be recruited to the study. All subjects undergo pre-screening for suitability and a physicians examination, as well as 7-day habitual daily steps are measured to ascertain baseline physical activity. Half of the recruited subjects (n=40) will be randomized into the intervention group and half (n=40) randomized into the control group. The intervention group is then required to reduce their daily steps to <2000 for a 2-week period. Thereafter, the intervention group participates to a 4-week strength+endurance training rehabilitation program and no longer has restricted daily step count. The control group continues their normal habitual physical activity level throughout the 6-week study period.
- Being tested
- Step-reduction/Exercise Rehab
- Medical subject headings
- Body Weight Changes, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step-reduction/Exercise RehabBehavioural
2-week limited daily steps (<2000), and then 4 weeks of typical strength+endurance exercise for older adults
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Two weeks of daily step reduction (limited to 2000 steps per day) followed by four weeks of supervised gym-based exercise rehabilitation (twice per week strength training and twice per week cycle endurance training) Receives: Behavioral: Step-reduction/Exercise Rehab |
| Control group | No intervention | Continued monitoring of habitual daily step count without structured intervention. Classic control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean leg mass
DXA-measured total lean mass of the legs
Measured: 6 weeks
Secondary outcomes (7)
Whole-body fat mass
DXA-measured total body fat mass
Measured: 6 weeks
Maximum isometric leg extension force
Maximum strength of legs
Measured: 6 weeks
Walking economy
Oxygen uptake while walking at 3 and 5 km.h-1
Measured: 6 weeks
Short Physical Performance Battery (SPPB)
Walking, balance and chair-rise tests
Measured: 6 weeks
Blood pressure
Systolic and diastolic blood pressure during rest (sitting)
Measured: 6 weeks
HOMA indices
Blood glucose and insulin concentration based calculations related to insulin resistance and beta-cell function
Measured: 6 weeks
White blood cell respiration
Isolated white blood cell respiration as a marker for mitochondrial function
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start15 Sep 2021
- Primary completion22 Dec 2021
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DegenerationStudies 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
- Model description
- Randomized Controlled Trial, with 2 parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jyvaskyla
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland
- Responsible party
- Sponsor
- Investigators
- Simon Walker, PhD, Principal investigator, University of Jyväskylä, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997447
- Sponsor's protocol ID
- SKR:271901-36456
- Acronym
- ENDURE
- Status last verified
- Aug 2023
- First submitted
- 1 Jul 2021
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enforced Reduction in Physical Activity and Recovery in Older Adults
- ClinicalTrials.gov ID
- NCT04997447
- Acronym / sponsor ID
- ENDURE / SKR:271901-36456
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of JyvaskylaUniversity, hospital or other
- Collaborators
- University of Eastern Finland
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 9 Aug 2021 (actual)
- 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.
Apparently healthy and well-functioning community dwelling 70-80 year-olds will be recruited to the study. All subjects undergo pre-screening for suitability and a physicians examination, as well as 7-day habitual daily steps are measured to ascertain baseline physical activity. Half of the recruited subjects (n=40) will be randomized into the intervention group and half (n=40) randomized into the control group. The intervention group is then required to reduce their daily steps to <2000 for a 2-week period. Thereafter, the intervention group participates to a 4-week strength+endurance training rehabilitation program and no longer has restricted daily step count. The control group continues their normal habitual physical activity level throughout the 6-week study period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial, with 2 parallel groups
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Step-reduction/Exercise RehabTwo weeks of daily step reduction (limited to 2000 steps per day) followed by four weeks of supervised gym-based exercise rehabilitation (twice per week strength training and twice per week cycle endurance training) |
| Control group | No intervention | –Continued monitoring of habitual daily step count without structured intervention. Classic control. |
Who may qualify
- Ages
- 70 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- aged 70-80 years,
- community-dwelling,
- able to walk 500 m without assistance or use of walking aid and regularly walking >5000 steps per day,
- MMSE >24,
- BMI 20-35 kg·m2 (i.e. not underweight or severely obese),
Key exclusion criteria (5 listed)
- Underlying diseases likely to limit lifespan and/or intervention safety. Contraindication for physical exercise or physical tests identified during physician's examination,
- unwilling/unable to track daily step counts using accelerometer,
- excessive and regular use of alcohol (more than 7 units per week for women and 14 for men)
- difficulty in communication due to severe vision or hearing problems
- unwilling to provide consent or accept randomization into either study group
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-reduction/Exercise Rehab2-week limited daily steps (<2000), and then 4 weeks of typical strength+endurance exercise for older adults | Behavioural | Intervention group |
Primary outcome
Lean leg mass
Time frame: 6 weeks
DXA-measured total lean mass of the legs
7 secondary outcomes
Whole-body fat mass
Time frame: 6 weeks
Maximum isometric leg extension force
Time frame: 6 weeks
Walking economy
Time frame: 6 weeks
Short Physical Performance Battery (SPPB)
Time frame: 6 weeks
Blood pressure
Time frame: 6 weeks
HOMA indices
Time frame: 6 weeks
White blood cell respiration
Time frame: 6 weeks
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 21 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Simon Walker, PhD principal investigator
University of Jyväskylä, Finland
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/Exercise Rehab in people with Muscle Degeneration and Body Weight Changes, run by University of Jyvaskyla at 1 site in Finland.
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 9 inclusion and 5 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 21 Aug 2023. 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 Finland. 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?
Lean leg mass (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2023.