NCT07046130

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
May 2025Dec 2026

Study Start

First participant enrolled

May 29, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2026

Expected
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

7 months

First QC Date

June 22, 2025

Last Update Submit

June 22, 2025

Conditions

Keywords

SarcopeniaStrength exerciseMuscle health

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    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)

    Up to end of study data collection (both stages), i.e., assessed up to 1 year

  • Average Power (Watts) - Isokinetic Knee Extension Test

    Up to end of study data collection (both stages), i.e., assessed up to 1 year

Study Arms (2)

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.

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.

Behavioral: Resistance Training

Interventions

The mininum resistance training volume (12 sets/week) will be applied.

Maintained Volume - 3 Sets (MV3SETS)Reduced Volume - 2 Sets and 1 Set (RV2SETS/RV1SET)

Eligibility Criteria

Age60 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Physical Education and Sports of Ribeirão Preto

Ribeirão Preto, São Paulo, 14050-230, Brazil

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

June 22, 2025

First Posted

July 1, 2025

Study Start

May 29, 2025

Primary Completion

December 18, 2025

Study Completion (Estimated)

December 18, 2026

Last Updated

July 1, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations