Exercise TrainingNCT05722899
Football 4 Health in Middle-aged to Older Adults
A study testing Football training in people with Exercise Training, run by KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Training
- What is being tested?
- Football training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2021to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Exercise Training
- Being tested
- Football training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Football trainingOther
10-week progressive football training with small-sided games, 2x/week, 45min-1h sessions
| Study group | Role | What they receive |
|---|---|---|
| Football training | Experimental | 10-week football training program with small-sided games, 2x/week, 45min-1h Receives: Other: Football training |
| Control | No intervention | No intervention, no changes in lifestyle and diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time Frame: Change from baseline in maximal power (watt) at 12 weeks
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.
Measured: Time Frame: Change from baseline in maximal force (N) at 12 weeks
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.
Measured: Time Frame: Change from baseline in maximal velocity (m/s) at 12 weeks
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.
Measured: Time Frame: Change from baseline in the slope of F-V profile at 12 weeks
Secondary outcomes (24)
Exercise adherence
Number of sessions attended as a percentage of total sessions planned
Measured: Total adherence over 10-week period
Enjoyment
Question: 'How much did you enjoy the training program?' Answer: 11-point Likert scale (0 = 'not at all...' to 10 = 'very...'
Measured: within 1 week post-intervention
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...'
Measured: within 1 week post-intervention
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...'
Measured: within 1 week post-intervention
External load: total distance
Total distance covered per training session, measured by means of GPS metrics
Measured: Average calculated over 10-week period
External load: meters in speed zones
Total meters in different speed zones per training session, measured by means of GPS metrics
Measured: Average calculated over 10-week period
Internal load: time in speed zones
Total time in different speed zones per training session, measured by means of GPS metrics
Measured: Average calculated over 10-week period
External load: number of accelerations
Number of accelerations (> 2m/s²), measured by means of GPS metrics
Measured: Average calculated over 10-week period
External load: number of decelerations
Number of decelerations (< -2m/s²), measured by means of GPS metrics
Measured: Average calculated over 10-week period
Internal load: average heart rate
Average heart rate (percent of heart rate max) during training session, measured by means of heart rate sensor
Measured: Average calculated over 10-week period
Internal load: time in heart rate zone
Total time in different heart rate zones per training session, measured by means of heart rate sensor
Measured: Average calculated over 10-week period
Gait speed
The average speed to walk 10m as fast as possible (in m/s)
Measured: Change from baseline in gait speed at 10 weeks
Countermovement jump height
Jump height (cm) in a countermovement jump
Measured: Change from baseline in countermovement jump height at 10 weeks
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)
Measured: Change from baseline in timed up and go time at 10 weeks
5-repetition sit-to-stand time
The time (s) needed to perform 5 sit-to-stand transitions.
Measured: Change from baseline in sit-to-stand performance at 10 weeks
5-repetition sit-to-stand power
The power (watt) needed to perform 5 sit-to-stand transitions.
Measured: Change from baseline in sit-to-stand performance at 10 weeks
Stair ascent time
The time (s) needed to ascend a flight of stairs.
Measured: Change from baseline in stair climbing performance at 10 weeks
Stair ascent power
The power (watt) needed to ascend a flight of stairs.
Measured: Change from baseline in stair climbing performance at 10 weeks
Body fat percentage
Percentage of body fat, measured with bio-electrical impedance analysis
Measured: Change from baseline in body fat percentage at 10 weeks
Skeletal muscle mass
Skeletal muscle mass, estimated with bio-electrical impedance analysis
Measured: Change from baseline in skeletal muscle mass at 10 weeks
Running speed at 2mM lactate
Endurance exercise capacity test on treadmill: running speed at 2mM lactate value
Measured: Change from baseline in running speed at 10 weeks
Running speed at 4mM lactate
Endurance exercise capacity test on treadmill: running speed at 4mM lactate value
Measured: Change from baseline in running speed at 10 weeks
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)
Measured: Change from baseline in RPE at 10 weeks
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)
Measured: Change from baseline in lactate at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Feb 2021
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TrainingStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evelien Van Roie, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722899
- Sponsor's protocol ID
- S64926
- Status last verified
- Jan 2023
- First submitted
- 20 Jan 2023
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05722899
- Acronym / sponsor ID
- S64926
- Conditions
- Exercise Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Football training | Experimental | Other: Football training10-week football training program with small-sided games, 2x/week, 45min-1h |
| Control | No intervention | –No intervention, no changes in lifestyle and diet |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Unstable cardiovascular disease
- Neurological disorders
- Cognitive malfunctioning
- Acute infections or fever
- Severe musculoskeletal problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Football training10-week progressive football training with small-sided games, 2x/week, 45min-1h sessions | Other | Football training |
Primary outcome
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.
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.
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.
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.
24 secondary outcomes
Exercise adherence
Time frame: Total adherence over 10-week period
Enjoyment
Time frame: within 1 week post-intervention
Score on feasibility questionnaire
Time frame: within 1 week post-intervention
Future intention to participate
Time frame: within 1 week post-intervention
External load: total distance
Time frame: Average calculated over 10-week period
External load: meters in speed zones
Time frame: Average calculated over 10-week period
Internal load: time in speed zones
Time frame: Average calculated over 10-week period
External load: number of accelerations
Time frame: Average calculated over 10-week period
External load: number of decelerations
Time frame: Average calculated over 10-week period
Internal load: average heart rate
Time frame: Average calculated over 10-week period
Internal load: time in heart rate zone
Time frame: Average calculated over 10-week period
Gait speed
Time frame: Change from baseline in gait speed at 10 weeks
Countermovement jump height
Time frame: Change from baseline in countermovement jump height at 10 weeks
Timed up and go
Time frame: Change from baseline in timed up and go time at 10 weeks
5-repetition sit-to-stand time
Time frame: 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
Stair ascent time
Time frame: Change from baseline in stair climbing performance at 10 weeks
Stair ascent power
Time frame: Change from baseline in stair climbing performance at 10 weeks
Body fat percentage
Time frame: Change from baseline in body fat percentage at 10 weeks
Skeletal muscle mass
Time frame: 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
Running speed at 4mM lactate
Time frame: Change from baseline in running speed at 10 weeks
Rate of perceived exertion (RPE)
Time frame: Change from baseline in RPE at 10 weeks
Lactate value
Time frame: Change from baseline in lactate at 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Football training in people with Exercise Training, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal power (time frame: Time Frame: Change from baseline in maximal power (watt) at 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.