AgingNCT06718712
Resistance Exercise Volume and Hypertrophic Response Variability in Elderly
A study testing Lower body resistance training in people with Aging and Muscle Hypertrophy, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The study aimed to investigate the effects of resistance training volume manipulation on whole muscle hypertrophy among non-responders and responders to a low resistance training dose (single-set). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aging, Muscle Hypertrophy
- What is being tested?
- Lower body resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2018to 20 Dec 2018
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years and older
- not engaged in regular resistance and/or aerobic training for at least six months before the intervention
Who cannot join
- diagnosed type I diabetes mellitus
- arrhythmia
- noncontrolled hypertension
- any major orthopedic musculoskeletal condition
- use of any dietary supplement or drug with potential anabolic effects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Resistance Exercise Volume on the Variability of the Hypertrophic Response in Elderly
The study aimed to investigate the effects of resistance training volume manipulation on whole muscle hypertrophy among non-responders and responders to a low resistance training dose (single-set).
Read the detailed description
The magnitude of muscle hypertrophy in response to resistance training (RT) is highly variable between individuals (response heterogeneity). Manipulations in RT variables may modulate RT-related response heterogeneity; yet, this remains to be determined.
- Conditions
- Aging, Muscle Hypertrophy
- Being tested
- Lower body resistance training
- Keywords
- aging, muscle mass, muscle strength, resistance exercise, sets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower body resistance trainingOther
The RT protocol was performed using a unilateral knee-extension machine. To reduce potential sources of bias to exercise order, subjects alternated the starting leg for each training session.
| Study group | Role | What they receive |
|---|---|---|
| Single set | Experimental | One set of unilateral knee-extension exercise of 8-15 RM with a 60-90 s interval. Receives: Other: Lower body resistance training |
| Four sets | Experimental | Four sets of unilateral knee-extension exercise of 8-15 RM with a 60-90 s interval between sets. Receives: Other: Lower body resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps muscle cross-sectional area
Quadriceps muscle CSA was obtained through magnetic resonance imaging.
Measured: 10 weeks
Secondary outcomes (1)
Maximum dynamic strength
Unilateral quadriceps 1-RM of both legs were assessed on a knee-extension machine
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Apr 2018
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Lower body unilateral design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Hamilton Augusto Roschel da Silva, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718712
- Sponsor's protocol ID
- 62590416.0.0000.5391
- Status last verified
- Nov 2024
- First submitted
- 1 Dec 2024
- Last updated
- 11 Dec 2024
- 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 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Exercise Volume on the Variability of the Hypertrophic Response in Elderly
- ClinicalTrials.gov ID
- NCT06718712
- Acronym / sponsor ID
- 62590416.0.0000.5391
- Conditions
- Aging, Muscle Hypertrophy
- Keywords
- aging, muscle mass, muscle strength, resistance exercise, sets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 5 Dec 2024 (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.
The study aimed to investigate the effects of resistance training volume manipulation on whole muscle hypertrophy among non-responders and responders to a low resistance training dose (single-set).
Detailed description
The magnitude of muscle hypertrophy in response to resistance training (RT) is highly variable between individuals (response heterogeneity). Manipulations in RT variables may modulate RT-related response heterogeneity; yet, this remains to be determined.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Lower body unilateral design
| Arm | Type | Receives |
|---|---|---|
| Single set | Experimental | Other: Lower body resistance trainingOne set of unilateral knee-extension exercise of 8-15 RM with a 60-90 s interval. |
| Four sets | Experimental | Other: Lower body resistance trainingFour sets of unilateral knee-extension exercise of 8-15 RM with a 60-90 s interval between sets. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 60 years and older
- not engaged in regular resistance and/or aerobic training for at least six months before the intervention
Key exclusion criteria (5 listed)
- diagnosed type I diabetes mellitus
- arrhythmia
- noncontrolled hypertension
- any major orthopedic musculoskeletal condition
- use of any dietary supplement or drug with potential anabolic effects
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 |
|---|---|---|
| Lower body resistance trainingThe RT protocol was performed using a unilateral knee-extension machine. To reduce potential sources of bias to exercise order, subjects alternated the starting leg for each training session. | Other | Four sets, Single set |
Primary outcome
Quadriceps muscle cross-sectional area
Time frame: 10 weeks
Quadriceps muscle CSA was obtained through magnetic resonance imaging.
1 secondary outcome
Maximum dynamic strength
Time frame: 10 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 11 Dec 2024.
- 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 Lower body resistance training in people with Aging and Muscle Hypertrophy, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 2 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 11 Dec 2024. 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 Brazil. 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?
Quadriceps muscle cross-sectional area (time frame: 10 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 11 Dec 2024.