Muscle Disuse AtrophyNCT03559452
Muscle Damage and Disuse Atrophy
A study testing Eccentric exercise in people with Muscle Disuse Atrophy, run by University of Exeter at 1 site in United Kingdom.
Trial summary
Limb injury generally requires a period of recovery during which time the limb is often immobilised (e.g. with a cast or brace) resulting in a rapid loss of skeletal muscle. Despite the importance of muscle loss during injury, our understanding of how it occurs is incomplete. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Disuse Atrophy
- What is being tested?
- Eccentric exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2018to 31 Oct 2019
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 - 40
- BMI between 18 and 27
- Healthy, recreationally active, non smoker
Who cannot join
- Non-removable metallic implants (including heart pacemaker, cochlear implants, medication pumps, surgical clips, plates or screws) or claustrophobia
- Use of nutritional supplements
- Chronic use of over the counter medication
- Any diagnosed metabolic disease (e.g. type 1 or 2 Diabetes).
- Any diagnosed cardiovascular disease or hypertension.
- Anyone with previous motor disorders. Anyone with a current musculoskeletal injury that may impair their use of crutches.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Young Healthy Males and Females, What is the Effect of Prior Eccentric Exercise on Thigh Muscle Atrophy During One Week of Leg Disuse Compared to no Prior Exercise?
Limb injury generally requires a period of recovery during which time the limb is often immobilised (e.g. with a cast or brace) resulting in a rapid loss of skeletal muscle. Despite the importance of muscle loss during injury, our understanding of how it occurs is incomplete. Several factors are likely to contribute, including a lack of muscle contraction and injury induced inflammation. In this study, the investigators will recruit healthy volunteers who will spend 7 days in a knee brace to replicate leg immobilisation. Prior to immobilisation, half of the participants will perform a single session of strenuous resistance exercise which is known to cause muscle damage and initiate an inflammatory response. This is designed to replicate the muscle damage and inflammation that occurs with injury. The remaining half of participants will not perform this exercise, allowing us to look at the additive effect of muscle damage and inflammation on muscle loss with immobilisation.
- Conditions
- Muscle Disuse Atrophy
- Being tested
- Eccentric exercise
- Keywords
- Muscle damage, Inflammation, Immobilisation
- Medical subject headings
- Muscular Disorders, Atrophic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric exerciseProcedure or surgery
300 eccentric contractions of the knee extensors
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Immobilisation without prior exercise |
| Muscle damage | Experimental | 300 bilateral knee extensor eccentric contraction performed immediately prior to immobilisation Receives: Procedure: Eccentric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in thigh muscle volume from pre-immobilisation
The volume of the muscles comprising the thigh after 2 days of immobilisation will be compared to pre-immobilisation values. This will be measured using MRI.
Measured: After 2 days of immobilisation
Change in thigh muscle volume from pre-immobilisation
The volume of the muscles comprising the thigh after 7 days of immobilisation will be compared to pre-immobilisation values, and values obtained after 2 days of immobilisation. This will be measured using MRI.
Measured: After 7 days of immobilisation
Secondary outcomes (7)
Change in unilateral knee extensor 1 repetition maximum
Unilateral knee extensor 1 repetition maximum will be measured before and after 7 days of single leg immobilisation using a weight stack leg extension machine
Measured: After 7 days of immobilisation
Change in unilateral knee extensor maximal voluntary torque production
Unilateral knee extensor maximal voluntary torque production will be measured before and after 7 days of single leg immobilisation using an isokinetic dynamometer.
Measured: After 7 days of immobilisation
Change in unilateral knee extensor isokinetic total work
Unilateral knee extensor total isokinetic work after 30 consecutive contractions will be measured before and after 7 days of single leg immobilisation using an isokinetic dynamometer.
Measured: After 7 days of immobilisation
Muscle protein synthesis assessed using the stable isotope Deuterium Oxide
The enrichment of deuterated alanine (from the deuterium oxide heavy water stable isotope tracer) in vastus lateralis biopsy samples will be measured relative to the non-deuterated alanine. The change between pre-immobilisation and 2 days of immobilisation will be used to calculated a fractional synthetic rate (% day).
Measured: After 2 days of immobilisation
Muscle protein synthesis assessed using the stable isotope Deuterium Oxide
The enrichment of deuterated alanine (from the deuterium oxide heavy water stable isotope tracer) in vastus lateralis biopsy samples will be measured relative to the non-deuterated alanine. The change between pre-immobilisation and 7 days of immobilisation will be used to calculated a fractional synthetic rate (% day).
Measured: After 7 days of immobilisation
Change in skeletal muscle gene expression
Skeletal muscle gene expression will be measured before and after 2 days of single leg immobilisation.
Measured: After 2 days of immobilisation
Change in skeletal muscle gene expression
Skeletal muscle gene expression will be measured before and after 7 days of single leg immobilisation.
Measured: After 7 days of immobilisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start1 May 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Disuse 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559452
- Sponsor's protocol ID
- 171206/B/08
- Status last verified
- Sep 2021
- First submitted
- 31 May 2018
- Last updated
- 27 Sep 2021
- 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 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Young Healthy Males and Females, What is the Effect of Prior Eccentric Exercise on Thigh Muscle Atrophy During One Week of Leg Disuse Compared to no Prior Exercise?
- ClinicalTrials.gov ID
- NCT03559452
- Acronym / sponsor ID
- 171206/B/08
- Conditions
- Muscle Disuse Atrophy
- Keywords
- Muscle damage, Inflammation, Immobilisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 18 Jun 2018 (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.
Limb injury generally requires a period of recovery during which time the limb is often immobilised (e.g. with a cast or brace) resulting in a rapid loss of skeletal muscle. Despite the importance of muscle loss during injury, our understanding of how it occurs is incomplete. Several factors are likely to contribute, including a lack of muscle contraction and injury induced inflammation. In this study, the investigators will recruit healthy volunteers who will spend 7 days in a knee brace to replicate leg immobilisation. Prior to immobilisation, half of the participants will perform a single session of strenuous resistance exercise which is known to cause muscle damage and initiate an inflammatory response. This is designed to replicate the muscle damage and inflammation that occurs with injury. The remaining half of participants will not perform this exercise, allowing us to look at the additive effect of muscle damage and inflammation on muscle loss with immobilisation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Immobilisation without prior exercise |
| Muscle damage | Experimental | Procedure: Eccentric exercise300 bilateral knee extensor eccentric contraction performed immediately prior to immobilisation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18 - 40
- BMI between 18 and 27
- Healthy, recreationally active, non smoker
Key exclusion criteria (6 listed)
- Non-removable metallic implants (including heart pacemaker, cochlear implants, medication pumps, surgical clips, plates or screws) or claustrophobia
- Use of nutritional supplements
- Chronic use of over the counter medication
- Any diagnosed metabolic disease (e.g. type 1 or 2 Diabetes).
- Any diagnosed cardiovascular disease or hypertension.
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 |
|---|---|---|
| Eccentric exercise300 eccentric contractions of the knee extensors | Procedure or surgery | Muscle damage |
Primary outcome
Change in thigh muscle volume from pre-immobilisation
Time frame: After 2 days of immobilisation
The volume of the muscles comprising the thigh after 2 days of immobilisation will be compared to pre-immobilisation values. This will be measured using MRI.
Change in thigh muscle volume from pre-immobilisation
Time frame: After 7 days of immobilisation
The volume of the muscles comprising the thigh after 7 days of immobilisation will be compared to pre-immobilisation values, and values obtained after 2 days of immobilisation. This will be measured using MRI.
7 secondary outcomes
Change in unilateral knee extensor 1 repetition maximum
Time frame: After 7 days of immobilisation
Change in unilateral knee extensor maximal voluntary torque production
Time frame: After 7 days of immobilisation
Change in unilateral knee extensor isokinetic total work
Time frame: After 7 days of immobilisation
Muscle protein synthesis assessed using the stable isotope Deuterium Oxide
Time frame: After 2 days of immobilisation
Muscle protein synthesis assessed using the stable isotope Deuterium Oxide
Time frame: After 7 days of immobilisation
Change in skeletal muscle gene expression
Time frame: After 2 days of immobilisation
Change in skeletal muscle gene expression
Time frame: After 7 days of immobilisation
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 27 Sep 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric exercise in people with Muscle Disuse Atrophy, run by University of Exeter 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 6 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 27 Sep 2021. 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?
Change in thigh muscle volume from pre-immobilisation (time frame: After 2 days of immobilisation). The study lists 2 primary outcomes in all. 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 27 Sep 2021.