Sarcopenia in ElderlyNCT07046130
Reduction in Resistance Training Volume and Neuromuscular Adaptations in Older Adults
A study testing Resistance Training in people with Sarcopenia in Elderly and Dynapenia, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to evaluate how reducing resistance training volume affects neuromuscular adaptations in older adults aged 60 to 70 years. The main questions it aims to answer are: Can strength and muscle adaptations be maintained with lower training volume? Does reducing training volume influence… Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia in Elderly, Dynapenia
- What is being tested?
- Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 29 May 2025to 18 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged between 60 and 70 years
- No participation in a regular resistance training program in the past six months
- Cleared for physical activity according to the Physical Activity Readiness Questionnaire (PAR-Q)
Who cannot join
- Musculoskeletal limitations that prevent participation in the training program
- Uncontrolled systemic arterial hypertension (resting systolic blood pressure >160 mmHg and/or diastolic >90 mmHg)
- Uncontrolled chronic diseases (e.g., heart failure, kidney disease, type 2 diabetes mellitus)
- Current diagnosis of cancer
- Unintentional weight loss of more than 3 kg in the past three months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
School of Physical Education and Sports of Ribeirão Preto
Ribeirão Preto, São Paulo, 14050-230
About this study
Official title: Effect of Reducing Resistance Training Volume on the inter-and Intra-individual Response of Neuromuscular Parameters in Older Adults
The goal of this clinical trial is to evaluate how reducing resistance training volume affects neuromuscular adaptations in older adults aged 60 to 70 years. The main questions it aims to answer are:
Can strength and muscle adaptations be maintained with lower training volume?
Read more
Does reducing training volume influence muscle power and hypertrophy in older adults?
Researchers will compare two groups:
A group that reduces training volume in one or both legs
A group that maintains the same training volume in both legs to see if reducing volume leads to different neuromuscular outcomes.
Participants will:
Complete an initial 10-week strength training program (2x/week) using unilateral leg press and knee extension machines, performing 3 sets per exercise
Undergo tests for muscle strength (1-RM), muscle thickness (ultrasound), and power (isokinetic dynamometry) at weeks 0, 5, and 10
After 10 weeks, be randomly assigned to:
A reduced-volume group: one leg does 2 sets and the other 1 set per exercise
Or a control group: both legs continue doing 3 sets
Continue training for another 10 weeks under the assigned protocol
Repeat strength, muscle thickness, and power assessments at weeks 5 and 10 of phase 2
Attend a dietary intake interview with a registered dietitian
This study will help determine the minimum effective training volume needed to maintain strength and muscle health in older adults, potentially improving long-term adherence to exercise programs.
Read the detailed description
Aging is associated with a progressive decline in muscle strength, muscle mass, and power, which can negatively affect functional capacity and quality of life in older adults. Resistance training (RT) is widely recognized as an effective intervention to mitigate these neuromuscular declines; however, adherence and long-term sustainability of high-volume RT programs can be challenging in this population due to reduced recovery capacity and potential lifestyle constraints. In this context, identifying the minimum effective training volume necessary to maintain neuromuscular adaptations is essential, as lower volumes may increase adherence among older adults. Therefore, this randomized, controlled clinical trial aims to investigate the effect of reducing RT volume on neuromuscular outcomes in older adults aged 60 to 70 years. The study will be conducted in two phases. In Phase 1, all participants will complete a 10-week RT program (2 sessions/week), performing three sets of unilateral leg press and knee extension exercises, with assessments of strength (1RM), muscle thickness (via ultrasound), power (via isokinetic dynamometry), body composition (via DXA), and dietary intake (via 24-hour recall) conducted at baseline, week 5, and week 10. Participants will be familiarized with the training procedures, and reliability in strength testing will be confirmed prior to the intervention. In Phase 2, participants will be randomized according to the delta (%) change in knee extension 1RM and assigned to one of two groups: a reduced-volume group, in which one leg performs two sets and the other one set (intra-subject design), or a control group maintaining three sets per leg. This second phase will also last 10 weeks, with follow-up assessments at weeks 5 and 10. The unilateral training design allows for within-subject comparisons to assess the impact of reduced volume, and the control group allows for between-group analysis, facilitating the identification of individual responses and determining whether neuromuscular adaptations can be maintained with lower training volumes after a standard RT protocol.
- Conditions
- Sarcopenia in Elderly, Dynapenia
- Being tested
- Resistance Training
- Keywords
- Sarcopenia, Strength exercise, Muscle health
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingBehavioural
The mininum resistance training volume (12 sets/week) will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Reduced Volume - 2 Sets and 1 Set (RV2SETS/RV1SET) | Experimental | This group will follow a reduced-volume training protocol in both legs, allowing for an intra-subject comparison. One leg will perform two sets per exercise (RV2SETS), and the other leg will perform only one set per exercise (RV1SET). This design will help assess whether neuromuscular adaptations can be maintained with lower training volume in older adults.
These participants will train twice per week for 10 weeks, performing unilateral leg press and unilateral knee extension exercises with two different set volumes (1 vs. 2 sets), one for each leg. Receives: Behavioral: Resistance Training |
| Maintained Volume - 3 Sets (MV3SETS) | Active comparator | This group will continue training with the same volume used during the initial phase of the study, which is three sets per exercise for both legs. This protocol aligns with standard resistance training guidelines for older adults aiming to promote strength and muscle maintenance.
These participants will perform three sets of unilateral leg press and unilateral knee extension exercises, twice per week, for 10 weeks. Receives: Behavioral: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Dynamic Strength (1-RM) in Knee Extension and Leg Press (kg)
This measurement will be assessed in both stages of the study.
In Phase 1 (initial training), 1-RM testing will be performed for unilateral knee extension and unilateral leg press exercises. After a familiarization session, participants will complete up to three testing sessions, 72 hours apart, until consistent values (≤5% variation) are reached. Assessments will be conducted at baseline (week 0), mid-intervention (week 5), and post-intervention (week 10).
In Phase 2 (volume manipulation), 1-RM measurements will be repeated at weeks 5 and 10, following the same standardized testing procedures. All evaluations will be performed at least 72 hours after the last training session to minimize the influence of acute fatigue on strength performance.
Measured: Up to end of study data collection (both stages), i.e., assessed up to 1 year
Secondary outcomes (3)
Muscle Thickness (cm) - Quadriceps Muscle Group (Ultrasound)
This measurement will be assessed in both stages of the study.
In Phase 1, muscle thickness of the quadriceps will be measured by B-mode ultrasound imaging at baseline (week 0), mid-intervention (week 5), and post-intervention (week 10). Measurements will be performed on both legs following a standardized protocol, with the participant in a rested state.
In Phase 2, the same procedure will be followed to reassess muscle thickness at weeks 5 and 10, with all evaluations occurring at least 72 hours after the last training session to reduce the influence of acute changes in muscle size.
Measured: Up to end of study data collection (both stages), i.e., assessed up to 1 year
Thigh Fat-Free Mass (kg) - Dual-Energy X-ray Absorptiometry (DXA)
This measurement will be assessed in both stages of the study.
Thigh fat-free mass will be evaluated by DXA scan at five time points: baseline (week 0), mid-intervention (week 5), and post-intervention (week 10) of Phase 1, as well as at week 5 and week 10 of Phase 2. Scans will be performed using a standardized protocol by trained technicians. Participants will be instructed to avoid vigorous physical activity and follow pre-assessment guidelines for 24 hours prior to each scan to ensure consistent and reliable measurements.
Measured: Up to end of study data collection (both stages), i.e., assessed up to 1 year
Average Power (Watts) - Isokinetic Knee Extension Test
This measurement will be assessed in both stages of the study.
Power of the knee extensors will be measured using an isokinetic dynamometer during concentric unilateral knee extension at standardized angular velocities. Assessments will be performed at baseline (week 0), mid-intervention (week 5), and post-intervention (week 10) in both phases.
All power assessments will be conducted at least 72 hours after the last training session to minimize the effects of fatigue and ensure valid measures of peak performance.
Measured: Up to end of study data collection (both stages), i.e., assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start29 May 2025
- Primary completion18 Dec 2025 (estimated)
- Study completion18 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenia in ElderlyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Santos Lopes da Silva, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046130
- Sponsor's protocol ID
- VRSETS6070
- Status last verified
- Jun 2025
- First submitted
- 22 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- 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 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Reducing Resistance Training Volume on the inter-and Intra-individual Response of Neuromuscular Parameters in Older Adults
- ClinicalTrials.gov ID
- NCT07046130
- Acronym / sponsor ID
- VRSETS6070
- Conditions
- Sarcopenia in Elderly, Dynapenia
- Keywords
- Sarcopenia, Strength exercise, Muscle health
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 29 May 2025 (actual)
- Primary completion
- 18 Dec 2025 (estimated)
- Study completion
- 18 Dec 2026 (estimated)
- First posted
- 1 Jul 2025 (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 goal of this clinical trial is to evaluate how reducing resistance training volume affects neuromuscular adaptations in older adults aged 60 to 70 years. The main questions it aims to answer are:
Can strength and muscle adaptations be maintained with lower training volume?
Does reducing training volume influence muscle power and hypertrophy in older adults?
Researchers will compare two groups:
A group that reduces training volume in one or both legs
A group that maintains the same training volume in both legs to see if reducing volume leads to different neuromuscular outcomes.
Participants will:
Complete an initial 10-week strength training program (2x/week) using unilateral leg press and knee extension machines, performing 3 sets per exercise
Undergo tests for muscle strength (1-RM), muscle thickness (ultrasound), and power (isokinetic dynamometry) at weeks 0, 5, and 10
After 10 weeks, be randomly assigned to:
A reduced-volume group: one leg does 2 sets and the other 1 set per exercise
Or a control group: both legs continue doing 3 sets
Continue training for another 10 weeks under the assigned protocol
Repeat strength, muscle thickness, and power assessments at weeks 5 and 10 of phase 2
Attend a dietary intake interview with a registered dietitian
This study will help determine the minimum effective training volume needed to maintain strength and muscle health in older adults, potentially improving long-term adherence to exercise programs.
Detailed description
Aging is associated with a progressive decline in muscle strength, muscle mass, and power, which can negatively affect functional capacity and quality of life in older adults. Resistance training (RT) is widely recognized as an effective intervention to mitigate these neuromuscular declines; however, adherence and long-term sustainability of high-volume RT programs can be challenging in this population due to reduced recovery capacity and potential lifestyle constraints. In this context, identifying the minimum effective training volume necessary to maintain neuromuscular adaptations is essential, as lower volumes may increase adherence among older adults. Therefore, this randomized, controlled clinical trial aims to investigate the effect of reducing RT volume on neuromuscular outcomes in older adults aged 60 to 70 years. The study will be conducted in two phases. In Phase 1, all participants will complete a 10-week RT program (2 sessions/week), performing three sets of unilateral leg press and knee extension exercises, with assessments of strength (1RM), muscle thickness (via ultrasound), power (via isokinetic dynamometry), body composition (via DXA), and dietary intake (via 24-hour recall) conducted at baseline, week 5, and week 10. Participants will be familiarized with the training procedures, and reliability in strength testing will be confirmed prior to the intervention. In Phase 2, participants will be randomized according to the delta (%) change in knee extension 1RM and assigned to one of two groups: a reduced-volume group, in which one leg performs two sets and the other one set (intra-subject design), or a control group maintaining three sets per leg. This second phase will also last 10 weeks, with follow-up assessments at weeks 5 and 10. The unilateral training design allows for within-subject comparisons to assess the impact of reduced volume, and the control group allows for between-group analysis, facilitating the identification of individual responses and determining whether neuromuscular adaptations can be maintained with lower training volumes after a standard RT protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced Volume - 2 Sets and 1 Set (RV2SETS/RV1SET) | Experimental | Behavioral: Resistance TrainingThis group will follow a reduced-volume training protocol in both legs, allowing for an intra-subject comparison. One leg will perform two sets per exercise (RV2SETS), and the other leg will perform only one set per exercise (RV1SET). This design will help assess whether neuromuscular adaptations can be maintained with lower training volume in older adults. These participants will train twice per week for 10 weeks, performing unilateral leg press and unilateral knee extension exercises with two different set volumes (1 vs. 2 sets), one for each leg. |
| Maintained Volume - 3 Sets (MV3SETS) | Active comparator | Behavioral: Resistance TrainingThis group will continue training with the same volume used during the initial phase of the study, which is three sets per exercise for both legs. This protocol aligns with standard resistance training guidelines for older adults aiming to promote strength and muscle maintenance. These participants will perform three sets of unilateral leg press and unilateral knee extension exercises, twice per week, for 10 weeks. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women aged between 60 and 70 years
- No participation in a regular resistance training program in the past six months
- Cleared for physical activity according to the Physical Activity Readiness Questionnaire (PAR-Q)
Key exclusion criteria (5 listed)
- Musculoskeletal limitations that prevent participation in the training program
- Uncontrolled systemic arterial hypertension (resting systolic blood pressure >160 mmHg and/or diastolic >90 mmHg)
- Uncontrolled chronic diseases (e.g., heart failure, kidney disease, type 2 diabetes mellitus)
- Current diagnosis of cancer
- Unintentional weight loss of more than 3 kg in the past three months
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 |
|---|---|---|
| Resistance TrainingThe mininum resistance training volume (12 sets/week) will be applied. | Behavioural | Maintained Volume - 3 Sets (MV3SETS), Reduced Volume - 2 Sets and 1 Set (RV2SETS/RV1SET) |
Primary outcome
Maximum Dynamic Strength (1-RM) in Knee Extension and Leg Press (kg)
Time frame: Up to end of study data collection (both stages), i.e., assessed up to 1 year
This measurement will be assessed in both stages of the study. In Phase 1 (initial training), 1-RM testing will be performed for unilateral knee extension and unilateral leg press exercises. After a familiarization session, participants will complete up to three testing sessions, 72 hours apart, until consistent values (≤5% variation) are reached. Assessments will be conducted at baseline (week 0), mid-intervention (week 5), and post-intervention (week 10). In Phase 2 (volume manipulation), 1-RM measurements will be repeated at weeks 5 and 10, following the same standardized testing procedures. All evaluations will be performed at least 72 hours after the last training session to minimize the influence of acute fatigue on strength performance.
3 secondary outcomes
Muscle Thickness (cm) - Quadriceps Muscle Group (Ultrasound)
Time frame: Up to end of study data collection (both stages), i.e., assessed up to 1 year
Thigh Fat-Free Mass (kg) - Dual-Energy X-ray Absorptiometry (DXA)
Time frame: Up to end of study data collection (both stages), i.e., assessed up to 1 year
Average Power (Watts) - Isokinetic Knee Extension Test
Time frame: Up to end of study data collection (both stages), i.e., assessed up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- 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.
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 Resistance Training in people with Sarcopenia in Elderly and Dynapenia, run by University of Sao Paulo 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 3 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: enrolling by invitation, as of the sponsor's last update on 1 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Maximum Dynamic Strength (1-RM) in Knee Extension and Leg Press (kg) (time frame: Up to end of study data collection (both stages), i.e., assessed up to 1 year). 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 1 Jul 2025.