Regeneration Potential of Healthy Old Men in Terms of Satellite Cell ActivationNCT01905345
Influence of Consecutive Strength- and Endurance Regimes on the Myonuclear Domain and Satellite Cell in the M. Vastus Lateralis of Old Healthy Men
A study testing Training in people with Regeneration Potential of Healthy Old Men in Terms of Satellite Cell Activation, run by University of Zurich at 1 site in Switzerland.
Trial summary
Randomised training intervention. Influence of consecutive training regime on the impact of the myonuclear domain and satellite cell Sarcopenia Despite that the muscle mass can be positively influenced by training, the loading with high weights and/or to the total exhaustion is for many old persons not possible. 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
- Regeneration Potential of Healthy Old Men in Terms of Satellite Cell Activation
- What is being tested?
- Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2013to Aug 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
- no fever at the beginning and during the study
- between 60 years and 75 years
- non smokers
- no known cardiovascular and orthopaedic problems
- no cardiac pacemaker
- fulfilling the health criteria
Who cannot join
- fever or cold at the beginning or during the study
- non MRI compatible metal implants
- under 60 years or over 75 years
- smoker
- cardiovascular or orthopaedic problems
- cardiac pacemaker
- not fulfilling the health criteria
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Neurology
Zurich, Canton of Zurich, 8091
About this study
Randomised training intervention.
Influence of consecutive training regime on the impact of the myonuclear domain and satellite cell
Sarcopenia
Despite that the muscle mass can be positively influenced by training, the loading with high weights and/or to the total exhaustion is for many old persons not possible.
Therefore we aim to enhance the myonuclei in the muscle fiber of old male subjects in a first phase by endurance training, in order to promote a more effective muscle growth in a second phase by resistance exercise.
- Being tested
- Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Endurance and Resistance Training | Experimental | Endurance and resistance exercise Receives: Procedure: Training |
| Resistance Training | Experimental | resistance exercise (12wk) Receives: Procedure: Training |
| Resistance and resistance Training | Experimental | resistance exercise (24 wk) Receives: Procedure: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in % from baseline in fibre type specific number of satellite cells, fibre type specific myonuclear domain [um^2], myonuclear number [%] in response to consecutive training regimes
Difference in % from baseline in fibre type specific number of satellite cells, fibre type specific myonuclear domain [um^2], myonuclear number [%] in response to consecutive training regimes
Measured: participants will be followed for the duration of training period, an expected average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2015
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regeneration Potential of Healthy Old Men in Terms of Satellite Cell ActivationStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans H Jung, Prof MD, Principal investigator, University Hospital Zurich, Division of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905345
- Sponsor's protocol ID
- REGPOT
- Status last verified
- Aug 2017
- First submitted
- 16 Jul 2013
- Last updated
- 7 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Consecutive Strength- and Endurance Regimes on the Myonuclear Domain and Satellite Cell in the M. Vastus Lateralis of Old Healthy Men
- ClinicalTrials.gov ID
- NCT01905345
- Acronym / sponsor ID
- REGPOT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 23 Jul 2013 (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.
Randomised training intervention.
Influence of consecutive training regime on the impact of the myonuclear domain and satellite cell
Sarcopenia
Despite that the muscle mass can be positively influenced by training, the loading with high weights and/or to the total exhaustion is for many old persons not possible.
Therefore we aim to enhance the myonuclei in the muscle fiber of old male subjects in a first phase by endurance training, in order to promote a more effective muscle growth in a second phase by resistance exercise.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endurance and Resistance Training | Experimental | Procedure: TrainingEndurance and resistance exercise |
| Resistance Training | Experimental | Procedure: Trainingresistance exercise (12wk) |
| Resistance and resistance Training | Experimental | Procedure: Trainingresistance exercise (24 wk) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- no fever at the beginning and during the study
- between 60 years and 75 years
- non smokers
- no known cardiovascular and orthopaedic problems
- no cardiac pacemaker
Key exclusion criteria (7 listed)
- fever or cold at the beginning or during the study
- non MRI compatible metal implants
- under 60 years or over 75 years
- smoker
- cardiovascular or orthopaedic problems
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 |
|---|---|---|
| Training | Procedure or surgery | Endurance and Resistance Training, Resistance Training, Resistance and resistance Training |
Primary outcome
Difference in % from baseline in fibre type specific number of satellite cells, fibre type specific myonuclear domain [um^2], myonuclear number [%] in response to consecutive training regimes
Time frame: participants will be followed for the duration of training period, an expected average of 7 months
Difference in % from baseline in fibre type specific number of satellite cells, fibre type specific myonuclear domain [um^2], myonuclear number [%] in response to consecutive training regimes
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 7 Aug 2017.
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.
Hans H Jung, Prof MD principal investigator
University Hospital Zurich, Division of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Regeneration Potential of Healthy Old Men in Terms of Satellite Cell Activation, run by University of Zurich at 1 site in Switzerland.
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 6 inclusion and 7 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 7 Aug 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 Switzerland. 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?
Difference in % from baseline in fibre type specific number of satellite cells, fibre type specific myonuclear domain [um^2], myonuclear number [%] in response to consecutive training regimes (time frame: participants will be followed for the duration of training period, an expected average of 7 months). 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 7 Aug 2017.