- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06449716
Tailored Versus Traditional Resistance Exercise
A Tailored Intervention to Prevent Age-Related Declines in Muscle Power and Functional Ability
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Belgium, 3000
- KU Leuven - Department of Movement Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Community-dwelling adults
- 65-80 years old
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Individualized resistance exercise program
Individualized exercise dose.
Individuals with a velocity deficit only perform low-load exercises.
Individuals with a force deficit only perform high-load exercises.
|
2x/week, 35-45 min sessions, on leg press machine
|
|
Active Comparator: Non-individualized resistance exercise program
Non-individualized exercise dose.
All individuals perform a combination of low-load and high-load resistance exercises, regardless of their deficit.
|
2x/week, 35-45 min sessions, on leg press machine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximal force (F0)
Time Frame: Change from baseline in maximal force at 12 weeks
|
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)
Time Frame: Change from baseline in maximal velocity at 12 weeks
|
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
Time Frame: Change from baseline in F-v slope at 12 weeks
|
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)
Time Frame: Change from baseline in maximal power at 12 weeks
|
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
Time Frame: Change from baseline in force at maximal power at 12 weeks
|
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
Time Frame: Change from baseline in velocity at maximal power at 12 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise adherence
Time Frame: Total adherence over 12-week period
|
Number of sessions attended as a percentage of total sessions planned
|
Total adherence over 12-week period
|
|
Short Physical Performance Battery (SPPB) score
Time Frame: Change from baseline in SPPB test score at 12 weeks
|
Total score on the SPPB (min 0, max 12, higher scores indicate better performance)
|
Change from baseline in SPPB test score at 12 weeks
|
|
Gait speed
Time Frame: Change from baseline in gait speed at 12 weeks
|
The average speed (m/s) to walk 10m as fast as possible
|
Change from baseline in gait speed at 12 weeks
|
|
Countermovement jump height
Time Frame: Change from baseline in countermovement jump height at 12 weeks
|
The jump height (cm) in a countermovement jump
|
Change from baseline in countermovement jump height at 12 weeks
|
|
Timed up and go
Time Frame: Change from baseline in timed up and go time at 12 weeks
|
The time (s) needed to stand up from a chair, walk 3 m, turn, walk back and sit down again (as fast as possible)
|
Change from baseline in timed up and go time at 12 weeks
|
|
5-repetition sit-to-stand time
Time Frame: Change from baseline in sit-to-stand performance at 12 weeks
|
The time (s) needed to perform 5 sit-to-stand transitions
|
Change from baseline in sit-to-stand performance at 12 weeks
|
|
5-repetition sit-to-stand power
Time Frame: Change from baseline in sit-to-stand performance at 12 weeks
|
The power (watt) needed to perform 5 sit-to-stand transitions
|
Change from baseline in sit-to-stand performance at 12 weeks
|
|
Stair ascent time
Time Frame: Change from baseline in stair climbing performance at 12 weeks
|
The time (s) needed to ascend a flight of stairs
|
Change from baseline in stair climbing performance at 12 weeks
|
|
Stair ascent power
Time Frame: Change from baseline in stair climbing performance at 12 weeks
|
The power (Watt) needed to ascend a flight of stairs
|
Change from baseline in stair climbing performance at 12 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- S68434
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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