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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05722899
Other study ID # S64926
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date July 15, 2021

Study information

Verified date January 2023
Source KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Ageing in humans is accompanied by a progressive decline in lower-limb muscle power production. In addition to a decline in musculoskeletal fitness, ageing is associated with a reduction in cardiovascular and metabolic fitness. Therefore, if exercise interventions aim for a high impact on the overall health status of middle-aged and older adults, they should combine endurance, high-intensity interval training and muscular strengthening activities. Recreational football training combines all these training components, which implies that it could constitute an adequate training modality for participants of all ages. What remains to be investigated in more detail, is whether recreational football training can improve muscle power production in middle-aged to older adults and whether this potential improvement is present across the full force-velocity (F-V) profile. Next to a detailed analysis of the leg-extensor F-V profile as primary outcome, simultaneous effects on functional capacity, body composition and endurance exercise capacity were investigated. In addition, feasibility and the physical demands (internal and external load indicators) of the training program were tracked throughout the intervention period.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 15, 2021
Est. primary completion date July 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 70 Years
Eligibility Exclusion Criteria: - Unstable cardiovascular disease - Neurological disorders - Cognitive malfunctioning - Acute infections or fever - Severe musculoskeletal problems - Systematic engagement in (resistance) exercise in the 12 months prior to participation

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Football training
10-week progressive football training with small-sided games, 2x/week, 45min-1h sessions

Locations

Country Name City State
Belgium Department of Movement Sciences Leuven

Sponsors (1)

Lead Sponsor Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximal power Force-velocity profiling is carried out unilaterally (dominant leg) on the pneumatic leg press device (Leg Press CC, HUR, Kokkola, Finland). The test protocol consists of a maximal isometric test (knee joint angle = 85°, hip angle = 55°; 3 attempts of 3s), followed by explosive concentric leg extensions at gradually increasing loads (unloaded, 15%, 30%, 45%, 60%, 75% of the maximal isometric force, 2-3 attempts per load, and additional single repetitions until one-repetition maximum is reached). 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 adaptations. Maximal power is used for the analyses. Time Frame: Change from baseline in maximal power (watt) at 12 weeks
Primary Maximal force Force-velocity profiling is carried out unilaterally (dominant leg) on the pneumatic leg press device (Leg Press CC, HUR, Kokkola, Finland). The test protocol consists of a maximal isometric test (knee joint angle = 85°, hip angle = 55°; 3 attempts of 3s), followed by explosive concentric leg extensions at gradually increasing loads (unloaded, 15%, 30%, 45%, 60%, 75% of the maximal isometric force, 2-3 attempts per load, and additional single repetitions until one-repetition maximum is reached). 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 adaptations. Maximal force is used for the analyses. Time Frame: Change from baseline in maximal force (N) at 12 weeks
Primary Maximal velocity Force-velocity profiling is carried out unilaterally (dominant leg) on the pneumatic leg press device (Leg Press CC, HUR, Kokkola, Finland). The test protocol consists of a maximal isometric test (knee joint angle = 85°, hip angle = 55°; 3 attempts of 3s), followed by explosive concentric leg extensions at gradually increasing loads (unloaded, 15%, 30%, 45%, 60%, 75% of the maximal isometric force, 2-3 attempts per load, and additional single repetitions until one-repetition maximum is reached). 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 adaptations. Maximal velocity is used for the analyses. Time Frame: Change from baseline in maximal velocity (m/s) at 12 weeks
Primary Slope of F-V profile Force-velocity profiling is carried out unilaterally (dominant leg) on the pneumatic leg press device (Leg Press CC, HUR, Kokkola, Finland). The test protocol consists of a maximal isometric test (knee joint angle = 85°, hip angle = 55°; 3 attempts of 3s), followed by explosive concentric leg extensions at gradually increasing loads (unloaded, 15%, 30%, 45%, 60%, 75% of the maximal isometric force, 2-3 attempts per load, and additional single repetitions until one-repetition maximum is reached). 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 adaptations. The equation's slope is used for the analyses. Time Frame: Change from baseline in the slope of F-V profile at 12 weeks
Secondary Exercise adherence Number of sessions attended as a percentage of total sessions planned Total adherence over 10-week period
Secondary Enjoyment Question: 'How much did you enjoy the training program?' Answer: 11-point Likert scale (0 = 'not at all...' to 10 = 'very...' within 1 week post-intervention
Secondary Score on feasibility questionnaire Question: 'How feasible was the training program for you?' Answer: 11-point Likert scale (0 = 'not at all...' to 10 = 'very...' within 1 week post-intervention
Secondary Future intention to participate Question: 'How high is the chance that you subscribe for a new sequence of training sessions?' Answer: 11-point Likert scale (0 = 'not at all...' to 10 = 'very...' within 1 week post-intervention
Secondary External load: total distance Total distance covered per training session, measured by means of GPS metrics Average calculated over 10-week period
Secondary External load: meters in speed zones Total meters in different speed zones per training session, measured by means of GPS metrics Average calculated over 10-week period
Secondary Internal load: time in speed zones Total time in different speed zones per training session, measured by means of GPS metrics Average calculated over 10-week period
Secondary External load: number of accelerations Number of accelerations (> 2m/s²), measured by means of GPS metrics Average calculated over 10-week period
Secondary External load: number of decelerations Number of decelerations (< -2m/s²), measured by means of GPS metrics Average calculated over 10-week period
Secondary Internal load: average heart rate Average heart rate (percent of heart rate max) during training session, measured by means of heart rate sensor Average calculated over 10-week period
Secondary Internal load: time in heart rate zone Total time in different heart rate zones per training session, measured by means of heart rate sensor Average calculated over 10-week period
Secondary Gait speed The average speed to walk 10m as fast as possible (in m/s) Change from baseline in gait speed at 10 weeks
Secondary Countermovement jump height Jump height (cm) in a countermovement jump Change from baseline in countermovement jump height at 10 weeks
Secondary Timed up and go Time (in 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 10 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 10 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 10 weeks
Secondary Stair ascent time The time (s) needed to ascend a flight of stairs. Change from baseline in stair climbing performance at 10 weeks
Secondary Stair ascent power The power (watt) needed to ascend a flight of stairs. Change from baseline in stair climbing performance at 10 weeks
Secondary Body fat percentage Percentage of body fat, measured with bio-electrical impedance analysis Change from baseline in body fat percentage at 10 weeks
Secondary Skeletal muscle mass Skeletal muscle mass, estimated with bio-electrical impedance analysis Change from baseline in skeletal muscle mass at 10 weeks
Secondary Running speed at 2mM lactate Endurance exercise capacity test on treadmill: running speed at 2mM lactate value Change from baseline in running speed at 10 weeks
Secondary Running speed at 4mM lactate Endurance exercise capacity test on treadmill: running speed at 4mM lactate value Change from baseline in running speed at 10 weeks
Secondary Rate of perceived exertion (RPE) RPE of the common highest intensity block, completed in the pre- as well as post-intervention test (i.e., values at the same speed level in both tests) Change from baseline in RPE at 10 weeks
Secondary Lactate value Lactate value of the common highest intensity block, completed in the pre- as well as post-intervention test (i.e., values at the same speed level in both tests) Change from baseline in lactate at 10 weeks
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