HealthyNCT00559806
The Effect of Aging and Immobilisation on Muscle
A study testing 2 weeks of unilateral immobilisation and 4 weeks of resistance training in people with Healthy, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The debilitating effects of immobilisation on muscle strength and size in young individuals are well documented. Moreover, sarcopenia has long been recognized as a major cause of muscle strength loss in old age, however, changes in muscle mass and architecture with immobilisation in the elderly has not previously been… Read more about this study
- Who is it for?
- Ages 20 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 2 weeks of unilateral immobilisation and 4 weeks of resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2007to May 2007
- 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 20 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Young healthy males (age 20-30 yrs)or old healthy males (age 60-80 yrs)
Who cannot join
- Musculoskeletal disorder
- Diabetes
- Cardiovascular disease
- Neurological diseases; or
- Cognitive disorders
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Sports Medicine, Bispebjerg Hospital
Copenhagen, 2400-NV
About this study
The debilitating effects of immobilisation on muscle strength and size in young individuals are well documented. Moreover, sarcopenia has long been recognized as a major cause of muscle strength loss in old age, however, changes in muscle mass and architecture with immobilisation in the elderly has not previously been investigated. This is contrasted by the fact that the elderly population more often undergoes periods of immobilization and disuse not only due to joint pain but also due to a higher degree of co morbidity and hospitalisation.The purpose of the present study was to compare the effect of a 2 week period of unilateral immobilisation on the physiological muscle cross sectional area, maximal isometric muscle strength, specific force, muscle fascicle length and muscle fibre pennation angle in young and old healthy men.
- Conditions
- Healthy
- Being tested
- 2 weeks of unilateral immobilisation and 4 weeks of resistance training
- Keywords
- immobilisation, aging, resistance training, atrophy, The effect of immobilisation in elderly compared to young individuals
- Medical subject headings
- Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 weeks of unilateral immobilisation and 4 weeks of resistance trainingOther
2 weeks of whole leg casting (side randomized)followed by 4 weeks of unilateral resistance training. The non-imm side served as a within-subject control
2 weeks of unilateral immobilisation and 4 weeks of resistance trainingOther
2 weeks of unilateral whole leg casting (side randomized)followed by 4 weeks of unilateral resistance training. The non-imm side served as a within-subject control
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 9 healthy elderly males Receives: Other: 2 weeks of unilateral immobilisation and 4 weeks of resistance training |
| 2 | Experimental | 11 healthy young males Receives: Other: 2 weeks of unilateral immobilisation and 4 weeks of resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle cross sectional area, maximal isometric muscle strength, specific force, muscle fascicle length and muscle fibre pennation
Measured: 2 weeks of immobilisation and 4 weeks of resistance training
Secondary outcomes (1)
single muscle fiber area, expression of myostatin and IGF-1 (RNA), changes in satellite activation and number
Measured: 2 weeks of imm and 4 weeks of resistance training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startJan 2007
- Study completionMay 2007
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Charlotte Suetta, MD, PhD, Principal investigator, Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559806
- Sponsor's protocol ID
- KF01-322606
- Status last verified
- Nov 2007
- First submitted
- 15 Nov 2007
- Last updated
- 16 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aging and Immobilisation on Muscle
- ClinicalTrials.gov ID
- NCT00559806
- Acronym / sponsor ID
- KF01-322606
- Conditions
- Healthy
- Keywords
- immobilisation, aging, resistance training, atrophy, The effect of immobilisation in elderly compared to young individuals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- May 2007 (actual)
- First posted
- 16 Nov 2007 (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 debilitating effects of immobilisation on muscle strength and size in young individuals are well documented. Moreover, sarcopenia has long been recognized as a major cause of muscle strength loss in old age, however, changes in muscle mass and architecture with immobilisation in the elderly has not previously been investigated. This is contrasted by the fact that the elderly population more often undergoes periods of immobilization and disuse not only due to joint pain but also due to a higher degree of co morbidity and hospitalisation.The purpose of the present study was to compare the effect of a 2 week period of unilateral immobilisation on the physiological muscle cross sectional area, maximal isometric muscle strength, specific force, muscle fascicle length and muscle fibre pennation angle in young and old healthy men.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: 2 weeks of unilateral immobilisation and 4 weeks of resistance training9 healthy elderly males |
| 2 | Experimental | Other: 2 weeks of unilateral immobilisation and 4 weeks of resistance training11 healthy young males |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Young healthy males (age 20-30 yrs)or old healthy males (age 60-80 yrs)
Key exclusion criteria (5 listed)
- Musculoskeletal disorder
- Diabetes
- Cardiovascular disease
- Neurological diseases; or
- Cognitive disorders
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 |
|---|---|---|
| 2 weeks of unilateral immobilisation and 4 weeks of resistance training2 weeks of whole leg casting (side randomized)followed by 4 weeks of unilateral resistance training. The non-imm side served as a within-subject control | Other | 1 |
| 2 weeks of unilateral immobilisation and 4 weeks of resistance training2 weeks of unilateral whole leg casting (side randomized)followed by 4 weeks of unilateral resistance training. The non-imm side served as a within-subject control | Other | 2 |
Primary outcome
muscle cross sectional area, maximal isometric muscle strength, specific force, muscle fascicle length and muscle fibre pennation
Time frame: 2 weeks of immobilisation and 4 weeks of resistance training
1 secondary outcome
single muscle fiber area, expression of myostatin and IGF-1 (RNA), changes in satellite activation and number
Time frame: 2 weeks of imm and 4 weeks of resistance training
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 16 Nov 2007.
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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.
Charlotte Suetta, MD, PhD principal investigator
Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 weeks of unilateral immobilisation and 4 weeks of resistance training in people with Healthy, run by Bispebjerg Hospital at 1 site in Denmark.
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 1 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 16 Nov 2007. 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 Denmark. 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 cross sectional area, maximal isometric muscle strength, specific force, muscle fascicle length and muscle fibre pennation (time frame: 2 weeks of immobilisation and 4 weeks of resistance training). 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 16 Nov 2007.