NCT06449716

Brief Summary

Preserving functional ability is crucial for healthy aging. Unfortunately, age-related decreases in muscle power often lead to declines in functional ability. As power is the product of force and velocity, decreases in power can originate from changes in muscle force, contraction velocity, or both, varying between individuals. The primary method to prevent functional disability is power-based resistance training. Although training interventions are effective for most older adults, they do not induce substantial improvements in a subset of the population. These inconsistent outcomes may arise from neglecting the observed differences in the force-velocity (F-v) profiles between individuals. Therefore, this study provides a novel approach to resistance exercise, in which exercise dose is tailored according to the individual's F-v profile. The effectiveness of the tailored method will be assessed in a randomized control trial, comparing the effects of an individualized and a non-individualized 12-week training intervention on muscle power parameters and functional ability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 5, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

May 20, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 10, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2025

Completed
Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

March 5, 2024

Last Update Submit

December 8, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Maximal force (F0)

    Unilateral (dominant leg) maximal force production (N) on the pneumatic leg press device (Leg Press Air 400, Keiser, USA). The test protocol consists of 2 sets of 1 repetition with increasing loads (5-10 kg increments), starting at 20% of body mass. When the participants fail to lift a certain load, the load will be decreased by 2.5-5 kg until their one repetition maximum (1-RM) is reached. The duration of the recovery time between sets will be based on the mean velocity in the preceding repetition, with longer rest periods after high-load, low-velocity attempts. Mean velocity of the best trial per load is used to estimate the individual F-v relationship through a linear equation. This F-v relationship will be used to examine the exercise-induced changes in maximal force.

    Change from baseline in maximal force at 12 weeks

  • Maximal velocity (V0)

    Unilateral (dominant leg) maximal velocity production (m/s) on the pneumatic leg press device (Leg Press Air 400, Keiser, USA). The test protocol consists of 2 sets of 1 repetition with increasing loads (5-10 kg increments), starting at 20% of body mass. When the participants fail to lift a certain load, the load will be decreased by 2.5-5 kg until their one repetition maximum (1-RM) is reached. The duration of the recovery time between sets will be based on the mean velocity in the preceding repetition, with longer rest periods after high-load, low-velocity attempts. Mean velocity of the best trial per load is used to estimate the individual F-v relationship through a linear equation. This F-v relationship will be used to examine the exercise-induced changes in maximal velocity.

    Change from baseline in maximal velocity at 12 weeks

  • Force-velocity slope

    Unilateral (dominant leg) force-velocity (F-v) slope on the pneumatic leg press device (Leg Press Air 400, Keiser, USA). F-v slope = force (N) as a function of velocity (m/s). The test protocol consists of 2 sets of 1 repetition with increasing loads (5-10 kg increments), starting at 20% of body mass. When the participants fail to lift a certain load, the load will be decreased by 2.5-5 kg until their one repetition maximum (1-RM) is reached. The duration of the recovery time between sets will be based on the mean velocity in the preceding repetition, with longer rest periods after high-load, low-velocity attempts. Mean velocity of the best trial per load is used to estimate the individual F-v relationship through a linear equation. This F-v relationship will be used to examine the exercise-induced changes in slope.

    Change from baseline in F-v slope at 12 weeks

  • Maximal power (P0)

    Unilateral (dominant leg) maximal power production (Watt) on the pneumatic leg press device (Leg Press Air 400, Keiser, USA). The test protocol consists of 2 sets of 1 repetition with increasing loads (5-10 kg increments), starting at 20% of body mass. When the participants fail to lift a certain load, the load will be decreased by 2.5-5 kg until their one repetition maximum (1-RM) is reached. The duration of the recovery time between sets will be based on the mean velocity in the preceding repetition, with longer rest periods after high-load, low-velocity attempts. Mean velocity of the best trial per load is used to estimate the individual F-v relationship through a linear equation. This F-v relationship will be used to examine the exercise-induced changes in maximal power.

    Change from baseline in maximal power at 12 weeks

  • Force at maximal power

    Unilateral (dominant leg) force at maximal power production (N) on the pneumatic leg press device (Leg Press Air 400, Keiser, USA). The test protocol consists of 2 sets of 1 repetition with increasing loads (5-10 kg increments), starting at 20% of body mass. When the participants fail to lift a certain load, the load will be decreased by 2.5-5 kg until their one repetition maximum (1-RM) is reached. The duration of the recovery time between sets will be based on the mean velocity in the preceding repetition, with longer rest periods after high-load, low-velocity attempts. Mean velocity of the best trial per load is used to estimate the individual F-v relationship through a linear equation. This F-v relationship will be used to examine the exercise-induced changes in force at maximal power.

    Change from baseline in force at maximal power at 12 weeks

  • Velocity at maximal power

    Unilateral (dominant leg) velocity at maximal power production (m/s) on the pneumatic leg press device (Leg Press Air 400, Keiser, USA). The test protocol consists of 2 sets of 1 repetition with increasing loads (5-10 kg increments), starting at 20% of body mass. When the participants fail to lift a certain load, the load will be decreased by 2.5-5 kg until their one repetition maximum (1-RM) is reached. The duration of the recovery time between sets will be based on the mean velocity in the preceding repetition, with longer rest periods after high-load, low-velocity attempts. Mean velocity of the best trial per load is used to estimate the individual F-v relationship through a linear equation. This F-v relationship will be used to examine the exercise-induced changes in velocity at maximal power.

    Change from baseline in velocity at maximal power at 12 weeks

Secondary Outcomes (9)

  • Exercise adherence

    Total adherence over 12-week period

  • Short Physical Performance Battery (SPPB) score

    Change from baseline in SPPB test score at 12 weeks

  • Gait speed

    Change from baseline in gait speed at 12 weeks

  • Countermovement jump height

    Change from baseline in countermovement jump height at 12 weeks

  • Timed up and go

    Change from baseline in timed up and go time at 12 weeks

  • +4 more secondary outcomes

Study Arms (2)

Individualized resistance exercise program

EXPERIMENTAL

Individualized exercise dose. Individuals with a velocity deficit only perform low-load exercises. Individuals with a force deficit only perform high-load exercises.

Other: 12-week progressive power-oriented resistance exercise program

Non-individualized resistance exercise program

ACTIVE COMPARATOR

Non-individualized exercise dose. All individuals perform a combination of low-load and high-load resistance exercises, regardless of their deficit.

Other: 12-week progressive power-oriented resistance exercise program

Interventions

2x/week, 35-45 min sessions, on leg press machine

Individualized resistance exercise programNon-individualized resistance exercise program

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Community-dwelling adults
  • years old

You may not qualify if:

  • Systematic engagement in resistance exercise during the past year
  • Unstable cardiovascular disease, neuromuscular disease, acute infection or fever
  • Recent surgery
  • Lower-extremity injuries
  • Low levels of functional ability (i.e., SPPB score ≤ 9)
  • Cognitive malfunctioning (i.e., Mini-Mental State Examination \< 24)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KU Leuven - Department of Movement Sciences

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 5, 2024

First Posted

June 10, 2024

Study Start

May 20, 2024

Primary Completion

December 4, 2025

Study Completion

December 4, 2025

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations