- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05722899
Football 4 Health in Middle-aged to Older Adults
January 31, 2023 updated by: Evelien Van Roie, KU Leuven
Ten Weeks of Recreational Football Training in 55- to 70-year-old Adults: Effects on Muscle Power, Functional Capacity, Body Composition and Endurance Exercise Capacity
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Leuven, Belgium, 3001
- Department of Movement Sciences
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Football training
10-week football training program with small-sided games, 2x/week, 45min-1h
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10-week progressive football training with small-sided games, 2x/week, 45min-1h sessions
|
|
NO_INTERVENTION: Control
No intervention, no changes in lifestyle and diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximal power
Time Frame: Time Frame: Change from baseline in maximal power (watt) at 12 weeks
|
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
|
|
Maximal force
Time Frame: Time Frame: Change from baseline in maximal force (N) at 12 weeks
|
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
|
|
Maximal velocity
Time Frame: Time Frame: Change from baseline in maximal velocity (m/s) at 12 weeks
|
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
|
|
Slope of F-V profile
Time Frame: Time Frame: Change from baseline in the slope of F-V profile at 12 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise adherence
Time Frame: Total adherence over 10-week period
|
Number of sessions attended as a percentage of total sessions planned
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Total adherence over 10-week period
|
|
Enjoyment
Time Frame: within 1 week post-intervention
|
Question: 'How much did you enjoy the training program?' Answer: 11-point Likert scale (0 = 'not at all...' to 10 = 'very...'
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within 1 week post-intervention
|
|
Score on feasibility questionnaire
Time Frame: within 1 week post-intervention
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Question: 'How feasible was the training program for you?' Answer: 11-point Likert scale (0 = 'not at all...' to 10 = 'very...'
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within 1 week post-intervention
|
|
Future intention to participate
Time Frame: within 1 week post-intervention
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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
|
|
External load: total distance
Time Frame: Average calculated over 10-week period
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Total distance covered per training session, measured by means of GPS metrics
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Average calculated over 10-week period
|
|
External load: meters in speed zones
Time Frame: Average calculated over 10-week period
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Total meters in different speed zones per training session, measured by means of GPS metrics
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Average calculated over 10-week period
|
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Internal load: time in speed zones
Time Frame: Average calculated over 10-week period
|
Total time in different speed zones per training session, measured by means of GPS metrics
|
Average calculated over 10-week period
|
|
External load: number of accelerations
Time Frame: Average calculated over 10-week period
|
Number of accelerations (> 2m/s²), measured by means of GPS metrics
|
Average calculated over 10-week period
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External load: number of decelerations
Time Frame: Average calculated over 10-week period
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Number of decelerations (< -2m/s²), measured by means of GPS metrics
|
Average calculated over 10-week period
|
|
Internal load: average heart rate
Time Frame: Average calculated over 10-week period
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Average heart rate (percent of heart rate max) during training session, measured by means of heart rate sensor
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Average calculated over 10-week period
|
|
Internal load: time in heart rate zone
Time Frame: Average calculated over 10-week period
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Total time in different heart rate zones per training session, measured by means of heart rate sensor
|
Average calculated over 10-week period
|
|
Gait speed
Time Frame: Change from baseline in gait speed at 10 weeks
|
The average speed to walk 10m as fast as possible (in m/s)
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Change from baseline in gait speed at 10 weeks
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Countermovement jump height
Time Frame: Change from baseline in countermovement jump height at 10 weeks
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Jump height (cm) in a countermovement jump
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Change from baseline in countermovement jump height at 10 weeks
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|
Timed up and go
Time Frame: Change from baseline in timed up and go time at 10 weeks
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Time (in s) needed to stand up from a chair, walk 3 m, turn, walk back and sit down again (as fast as possible)
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Change from baseline in timed up and go time at 10 weeks
|
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5-repetition sit-to-stand time
Time Frame: Change from baseline in sit-to-stand performance at 10 weeks
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The time (s) needed to perform 5 sit-to-stand transitions.
|
Change from baseline in sit-to-stand performance at 10 weeks
|
|
5-repetition sit-to-stand power
Time Frame: Change from baseline in sit-to-stand performance at 10 weeks
|
The power (watt) needed to perform 5 sit-to-stand transitions.
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Change from baseline in sit-to-stand performance at 10 weeks
|
|
Stair ascent time
Time Frame: Change from baseline in stair climbing performance at 10 weeks
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The time (s) needed to ascend a flight of stairs.
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Change from baseline in stair climbing performance at 10 weeks
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Stair ascent power
Time Frame: Change from baseline in stair climbing performance at 10 weeks
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The power (watt) needed to ascend a flight of stairs.
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Change from baseline in stair climbing performance at 10 weeks
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Body fat percentage
Time Frame: Change from baseline in body fat percentage at 10 weeks
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Percentage of body fat, measured with bio-electrical impedance analysis
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Change from baseline in body fat percentage at 10 weeks
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Skeletal muscle mass
Time Frame: Change from baseline in skeletal muscle mass at 10 weeks
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Skeletal muscle mass, estimated with bio-electrical impedance analysis
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Change from baseline in skeletal muscle mass at 10 weeks
|
|
Running speed at 2mM lactate
Time Frame: Change from baseline in running speed at 10 weeks
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Endurance exercise capacity test on treadmill: running speed at 2mM lactate value
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Change from baseline in running speed at 10 weeks
|
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Running speed at 4mM lactate
Time Frame: Change from baseline in running speed at 10 weeks
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Endurance exercise capacity test on treadmill: running speed at 4mM lactate value
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Change from baseline in running speed at 10 weeks
|
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Rate of perceived exertion (RPE)
Time Frame: Change from baseline in RPE at 10 weeks
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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)
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Change from baseline in RPE at 10 weeks
|
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Lactate value
Time Frame: Change from baseline in lactate at 10 weeks
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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)
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Change from baseline in lactate at 10 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 1, 2021
Primary Completion (ACTUAL)
July 15, 2021
Study Completion (ACTUAL)
July 15, 2021
Study Registration Dates
First Submitted
January 20, 2023
First Submitted That Met QC Criteria
January 31, 2023
First Posted (ACTUAL)
February 10, 2023
Study Record Updates
Last Update Posted (ACTUAL)
February 10, 2023
Last Update Submitted That Met QC Criteria
January 31, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- S64926
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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