- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06449716
Individualized Versus Non-Individualized Resistance Training
A Tailored Intervention to Prevent Age-Related Declines in Muscle Power and Functional Ability
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.
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
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Community-dwelling adults
- At least 65 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. All individuals perform resistance exercises at a load that targets their deficit. Individuals with a velocity deficit train at low loads while individuals with a force deficit train at high loads. |
2x/week, 35-45 min sessions, on leg press machine |
|
Active Comparator: Non-individualized resistance exercise program
Non-individualized exercise dose. All individuals perform resistance exercises at a load that does not target their deficit. Individuals with a velocity deficit train at high loads while individuals with a force deficit train at low loads. |
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 power (Pmax)
Time Frame: Change from baseline at 6 and 12 weeks
|
Participants performed explosive unilateral leg extensions with the dominant leg at five submaximal loads on a pneumatic leg press (Leg Press Air 400, Keiser, USA). Submaximal loads were scaled to the estimated maximal isometric force derived from the familiarization session. The three lighter loads were performed three times each and the two heavier loads twice, with the repetition yielding the highest mean concentric velocity retained for analysis. Participants subsequently performed single repetitions at incrementally increasing loads until 1-RM was reached. Rest intervals were adjusted according to the load of the preceding trial: 60 s after the three lightest loads, 90 s after the two heavier loads, and 120 s during the incremental trials leading to 1-RM. For each load, the mean concentric velocity of the best trial was used to establish the individual force-velocity (F-V) relationship using linear regression, from which the maximal power (Pmax; W) was estimated. |
Change from baseline at 6 and 12 weeks
|
|
Maximal isometric force (F0)
Time Frame: Change from baseline at 6 and 12 weeks
|
Participants performed explosive unilateral leg extensions with the dominant leg at five submaximal loads on a pneumatic leg press (Leg Press Air 400, Keiser, USA). Submaximal loads were scaled to the estimated maximal isometric force derived from the familiarization session. The three lighter loads were performed three times each and the two heavier loads twice, with the repetition yielding the highest mean concentric velocity retained for analysis. Participants subsequently performed single repetitions at incrementally increasing loads until 1-RM was reached. Rest intervals were adjusted according to the load of the preceding trial: 60 s after the three lightest loads, 90 s after the two heavier loads, and 120 s during the incremental trials leading to 1-RM. For each load, the mean concentric velocity of the best trial was used to establish the individual force-velocity (F-V) relationship using linear regression, from which maximal isometric force (F0; N) was estimated. |
Change from baseline at 6 and 12 weeks
|
|
Maximal unloaded velocity (V0)
Time Frame: Change from baseline at 6 and 12 weeks
|
Participants performed explosive unilateral leg extensions with the dominant leg at five submaximal loads on a pneumatic leg press (Leg Press Air 400, Keiser, USA). Submaximal loads were scaled to the estimated maximal isometric force derived from the familiarization session. The three lighter loads were performed three times each and the two heavier loads twice, with the repetition yielding the highest mean concentric velocity retained for analysis. Participants subsequently performed single repetitions at incrementally increasing loads until 1-RM was reached. Rest intervals were adjusted according to the load of the preceding trial: 60 s after the three lightest loads, 90 s after the two heavier loads, and 120 s during the incremental trials leading to 1-RM. For each load, the mean concentric velocity of the best trial was used to establish the individual force-velocity (F-V) relationship using linear regression, from which maximal unloaded velocity (V0; m/s) was estimated. |
Change from baseline at 6 and 12 weeks
|
|
Force-velocity slope
Time Frame: Change from baseline at 6 and 12 weeks
|
Participants performed explosive unilateral leg extensions with the dominant leg at five submaximal loads on a pneumatic leg press (Leg Press Air 400, Keiser, USA). Submaximal loads were scaled to the estimated maximal isometric force derived from the familiarization session. The three lighter loads were performed three times each and the two heavier loads twice, with the repetition yielding the highest mean concentric velocity retained for analysis. Participants subsequently performed single repetitions at incrementally increasing loads until 1-RM was reached. Rest intervals were adjusted according to the load of the preceding trial: 60 s after the three lightest loads, 90 s after the two heavier loads, and 120 s during the incremental trials leading to 1-RM. For each load, the mean concentric velocity of the best trial was used to establish the individual force-velocity (F-V) relationship using linear regression, from which the F-V slope (Ns/m) was derived. |
Change from baseline at 6 and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Physical Performance Battery (SPPB)
Time Frame: Score at baseline
|
Total score on the SPPB (min 0, max 12, higher scores indicate better performance) |
Score at baseline
|
|
Hand grip strength
Time Frame: Change from baseline at 6 and 12 weeks
|
Maximal grip strength (kg) of the dominant hand using an isometric dynamometer adjusted for hand size |
Change from baseline at 6 and 12 weeks
|
|
Maximal gait speed
Time Frame: Change from baseline at 6 and 12 weeks
|
The average time (s) to walk 10m as fast as possible |
Change from baseline at 6 and 12 weeks
|
|
Countermovement jump
Time Frame: Change from baseline at 6 and 12 weeks
|
The jump height (mm) in a countermovement jump |
Change from baseline at 6 and 12 weeks
|
|
Timed up-and-go
Time Frame: Change from baseline at 6 and 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 at 6 and 12 weeks
|
|
5-repetition sit-to-stand time
Time Frame: Change from baseline at 6 and 12 weeks
|
The time (s) needed to complete the 5-repetition sit-to-stand test |
Change from baseline at 6 and 12 weeks
|
|
5-repetition sit-to-stand power
Time Frame: Change from baseline at 6 and 12 weeks
|
The average power (watt) produced during the 5-repetition sit-to-stand test |
Change from baseline at 6 and 12 weeks
|
|
30-second sit-to-stand repetitions
Time Frame: Change from baseline at 6 and 12 weeks
|
The number of repetitions completed during the 30-second sit-to-stand test |
Change from baseline at 6 and 12 weeks
|
|
30-second sit-to-stand power
Time Frame: Change from baseline at 6 and 12 weeks
|
The average power (watt) produced during the 30-second sit-to-stand test |
Change from baseline at 6 and 12 weeks
|
|
Stair ascent time
Time Frame: Change from baseline at 6 and 12 weeks
|
The time (s) needed to ascend a flight of stairs |
Change from baseline at 6 and 12 weeks
|
|
Stair ascent power
Time Frame: Change from baseline at 6 and 12 weeks
|
The average power (Watt) produced during the stair ascent test |
Change from baseline at 6 and 12 weeks
|
|
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
|
|
Absolute training load
Time Frame: Consistently recorded throughout the 12-week intervention
|
The absolute load (kg) used during training sessions |
Consistently recorded throughout the 12-week intervention
|
|
Relative training load
Time Frame: Consistently recorded throughout the 12-week intervention
|
The relative load (%1RM) used during training sessions |
Consistently recorded throughout the 12-week intervention
|
|
Number of repetitions
Time Frame: Consistently recorded throughout the 12-week intervention
|
The number of repetitions (n) completed per set |
Consistently recorded throughout the 12-week intervention
|
|
Highest movement velocity within a set
Time Frame: Consistently recorded throughout the 12-week intervention
|
The velocity (m/s) of the fastest repetition in a set (Vmax) |
Consistently recorded throughout the 12-week intervention
|
|
Lowest movement velocity within a set
Time Frame: Consistently recorded throughout the 12-week intervention
|
The velocity (m/s) of the slowest repetition in a set (Vmin) |
Consistently recorded throughout the 12-week intervention
|
|
Velocity loss
Time Frame: Consistently recorded throughout the 12-week intervention
|
The percentage difference between the highest and lowest movement velocity in a set = ([Vmax - Vmin] / Vmax) × 100 |
Consistently recorded throughout the 12-week intervention
|
|
Set-volume index
Time Frame: Consistently recorded throughout the 12-week intervention
|
The number of repetitions × relative load (%1-RM) per set |
Consistently recorded throughout the 12-week intervention
|
|
Session-volume index
Time Frame: Consistently recorded throughout the 12-week intervention
|
The sum of set volumes per session |
Consistently recorded throughout the 12-week intervention
|
Collaborators and Investigators
Publications and helpful links
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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