NCT05722899

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
Last Updated

February 10, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

January 20, 2023

Last Update Submit

January 31, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (24)

  • Exercise adherence

    Total adherence over 10-week period

  • Enjoyment

    within 1 week post-intervention

  • Score on feasibility questionnaire

    within 1 week post-intervention

  • Future intention to participate

    within 1 week post-intervention

  • External load: total distance

    Average calculated over 10-week period

  • +19 more secondary outcomes

Study Arms (2)

Football training

EXPERIMENTAL

10-week football training program with small-sided games, 2x/week, 45min-1h

Other: Football training

Control

NO INTERVENTION

No intervention, no changes in lifestyle and diet

Interventions

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

Football training

Eligibility Criteria

Age55 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Movement Sciences

Leuven, 3001, Belgium

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 20, 2023

First Posted

February 10, 2023

Study Start

February 1, 2021

Primary Completion

July 15, 2021

Study Completion

July 15, 2021

Last Updated

February 10, 2023

Record last verified: 2023-01

Locations