HealthyNCT02142855
Structural and Metabolic Determinants of Sarcopenia and the Efficacy of Concentric vs. Eccentric Exercise Training
A study testing Concentric Exercise Training and Eccentric Exercise Training in people with Healthy, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The first goal of this study is the follow young and older people over a period of 8 weeks to define the processes responsible for loss of muscle length and width in age-related muscle wasting (sarcopenia) and allow us to look at age-related differences in tendon. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Concentric Exercise Training and Eccentric Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to May 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 18 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male volunteers
- Body mass index 18-30 kg/m2
- Aged 18-35 and 65-75 years
Who cannot join
- Participation in a formal exercise regime,
- A BMI < 18 or > 30 kg/m2,
- Active cardiovascular disease,
- Taking beta-adrenergic blocking agents, statins or non-steroidal anti-inflammatory drugs,
- Cerebrovascular disease,
- Respiratory disease,
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- Metabolic disease,
- Active inflammatory bowel or renal disease,
- Malignancy,
- Recent steroid treatment (within 6 months) or hormone replacement therapy,
- Clotting dysfunction,
- Musculoskeletal or neurological disorders,
- Family history of early (<55y) death from cardiovascular disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Derby, Derbyshire, DE22 3DT
About this study
Official title: Structural and Metabolic Determinants of Sarcopenia and the Efficacy of Concentric vs. Eccentric Exercise Training: a Novel Temporospatial Approach
The first goal of this study is the follow young and older people over a period of 8 weeks to define the processes responsible for loss of muscle length and width in age-related muscle wasting (sarcopenia) and allow us to look at age-related differences in tendon. Secondly, we will assess two different exercise interventions for reversing human sarcopenia; one which involves shortening of the muscle and the other which involves lengthening, whilst also studying why these exercises work the way they do. This project will have significant implications for our understanding of the control of skeletal muscle and tendon size in humans, particularly in relation to sarcopenia and the surrounding health issues.
- Conditions
- Healthy
- Being tested
- Concentric Exercise Training, Eccentric Exercise Training
- Keywords
- volunteers, young (18-30 y), older (65-75 y), age groups
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concentric Exercise TrainingBehavioural
8 weeks concentric exercise training, 3 x per week, 60% 1-RM; 4 x 12-15 repetitions, 2 min rest between sets
Eccentric Exercise TrainingBehavioural
8 weeks eccentric exercise training, 3 x per week, 60% 1-RM; 4 x 12-15 repetitions, 2 min rest between sets
| Study group | Role | What they receive |
|---|---|---|
| Old Control | No intervention | Older individuals (65-75 y) with no exercise intervention |
| Old Concentric | Experimental | Older individuals (65-75 y) studied before and after 8 weeks concentric exercise training Receives: Behavioral: Concentric Exercise Training |
| Old Eccentric | Experimental | Older individuals (65-75 y) studied before and after 8 weeks eccentric exercise training Receives: Behavioral: Eccentric Exercise Training |
| Young Control | No intervention | Young individuals (18-30 y) with no exercise intervention |
| Young Concentric | Experimental | Young individuals (18-30 y) studied before and after 8 weeks concentric exercise training Receives: Behavioral: Concentric Exercise Training |
| Young Eccentric | Experimental | Young individuals (18-30 y) studied before and after 8 weeks eccentric exercise training Receives: Behavioral: Eccentric Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis
Comparison of muscle protein synthesis using D2O in young and older individuals and in response to 8 weeks concentric or eccentric exercise training
Measured: 0 - 8 weeks
Secondary outcomes (1)
Tendon protein synthesis
Comparison of tendon protein synthesis in young and older individuals and in response to 8 weeks concentric or eccentric exercise training
Measured: 0 - 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council
- Responsible party
- Sponsor
- Investigators
- Marco V Narici, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142855
- Sponsor's protocol ID
- B13032014 SoMSGEM BBSRC3
- Status last verified
- Oct 2017
- First submitted
- 16 May 2014
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Metabolic Determinants of Sarcopenia and the Efficacy of Concentric vs. Eccentric Exercise Training: a Novel Temporospatial Approach
- ClinicalTrials.gov ID
- NCT02142855
- Acronym / sponsor ID
- B13032014 SoMSGEM BBSRC3
- Conditions
- Healthy
- Keywords
- volunteers, young (18-30 y), older (65-75 y), age groups
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council
- Study start
- May 2014
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 20 May 2014 (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.
The first goal of this study is the follow young and older people over a period of 8 weeks to define the processes responsible for loss of muscle length and width in age-related muscle wasting (sarcopenia) and allow us to look at age-related differences in tendon. Secondly, we will assess two different exercise interventions for reversing human sarcopenia; one which involves shortening of the muscle and the other which involves lengthening, whilst also studying why these exercises work the way they do. This project will have significant implications for our understanding of the control of skeletal muscle and tendon size in humans, particularly in relation to sarcopenia and the surrounding health issues.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Old Control | No intervention | –Older individuals (65-75 y) with no exercise intervention |
| Old Concentric | Experimental | Behavioral: Concentric Exercise TrainingOlder individuals (65-75 y) studied before and after 8 weeks concentric exercise training |
| Old Eccentric | Experimental | Behavioral: Eccentric Exercise TrainingOlder individuals (65-75 y) studied before and after 8 weeks eccentric exercise training |
| Young Control | No intervention | –Young individuals (18-30 y) with no exercise intervention |
| Young Concentric | Experimental | Behavioral: Concentric Exercise TrainingYoung individuals (18-30 y) studied before and after 8 weeks concentric exercise training |
| Young Eccentric | Experimental | Behavioral: Eccentric Exercise TrainingYoung individuals (18-30 y) studied before and after 8 weeks eccentric exercise training |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male volunteers
- Body mass index 18-30 kg/m2
- Aged 18-35 and 65-75 years
Key exclusion criteria (13 listed)
- Participation in a formal exercise regime,
- A BMI < 18 or > 30 kg/m2,
- Active cardiovascular disease,
- Taking beta-adrenergic blocking agents, statins or non-steroidal anti-inflammatory drugs,
- Cerebrovascular disease,
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 |
|---|---|---|
| Concentric Exercise Training8 weeks concentric exercise training, 3 x per week, 60% 1-RM; 4 x 12-15 repetitions, 2 min rest between sets | Behavioural | Old Concentric, Young Concentric |
| Eccentric Exercise Training8 weeks eccentric exercise training, 3 x per week, 60% 1-RM; 4 x 12-15 repetitions, 2 min rest between sets | Behavioural | Old Eccentric, Young Eccentric |
Primary outcome
Muscle protein synthesis
Time frame: 0 - 8 weeks
Comparison of muscle protein synthesis using D2O in young and older individuals and in response to 8 weeks concentric or eccentric exercise training
1 secondary outcome
Tendon protein synthesis
Time frame: 0 - 8 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 30 Oct 2017.
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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.
Marco V Narici, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concentric Exercise Training and Eccentric Exercise Training in people with Healthy, run by University of Nottingham 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 3 inclusion and 13 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 30 Oct 2017. 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?
Muscle protein synthesis (time frame: 0 - 8 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 30 Oct 2017.