Tailored Versus Traditional Resistance Exercise

Exercise Training Clinical Trial

Official title:

A Tailored Intervention to Prevent Age-Related Declines in Muscle Power and Functional Ability

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06449716
• Other study ID #: S68434
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: March 2025

Study information

• Verified date: June 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Christophe Delecluse
• Phone: +32 16 32 90 76
• Email: christophe.delecluse[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Exercise Training

Intervention

Other:
• 12-week progressive power-oriented resistance exercise program
2x/week, 35-45 min sessions, on leg press machine

Locations

Country	Name	City	State
Belgium	KU Leuven - Department of Movement Sciences	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Exercise adherence	Number of sessions attended as a percentage of total sessions planned	Total adherence over 12-week period
Secondary	Short Physical Performance Battery (SPPB) score	Total score on the SPPB (min 0, max 12, higher scores indicate better performance)	Change from baseline in SPPB test score at 12 weeks
Secondary	Gait speed	The average speed (m/s) to walk 10m as fast as possible	Change from baseline in gait speed at 12 weeks
Secondary	Countermovement jump height	The jump height (cm) in a countermovement jump	Change from baseline in countermovement jump height at 12 weeks
Secondary	Timed up and go	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
Secondary	5-repetition sit-to-stand time	The time (s) needed to perform 5 sit-to-stand transitions	Change from baseline in sit-to-stand performance at 12 weeks
Secondary	5-repetition sit-to-stand power	The power (watt) needed to perform 5 sit-to-stand transitions	Change from baseline in sit-to-stand performance at 12 weeks
Secondary	Stair ascent time	The time (s) needed to ascend a flight of stairs	Change from baseline in stair climbing performance at 12 weeks
Secondary	Stair ascent power	The power (Watt) needed to ascend a flight of stairs	Change from baseline in stair climbing performance at 12 weeks