- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06449716
Individualized Versus Non-Individualized Resistance Training
En skræddersyet intervention for at forhindre aldersrelaterede fald i muskelkraft og funktionsevne
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Belgien, 3000
- KU Leuven - Department of Movement Sciences
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Community-dwelling adults
- At least 65 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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Individualized resistance exercise program
Individualized exercise dose. All individuals perform resistance exercises at a load that targets their deficit. Individuals with a velocity deficit train at low loads while individuals with a force deficit train at high loads. |
2x/week, 35-45 min sessions, on leg press machine |
|
Aktiv komparator: Non-individualized resistance exercise program
Non-individualized exercise dose. All individuals perform resistance exercises at a load that does not target their deficit. Individuals with a velocity deficit train at high loads while individuals with a force deficit train at low loads. |
2x/week, 35-45 min sessions, on leg press machine |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximal power (Pmax)
Tidsramme: Change from baseline at 6 and 12 weeks
|
Participants performed explosive unilateral leg extensions with the dominant leg at five submaximal loads on a pneumatic leg press (Leg Press Air 400, Keiser, USA). Submaximal loads were scaled to the estimated maximal isometric force derived from the familiarization session. The three lighter loads were performed three times each and the two heavier loads twice, with the repetition yielding the highest mean concentric velocity retained for analysis. Participants subsequently performed single repetitions at incrementally increasing loads until 1-RM was reached. Rest intervals were adjusted according to the load of the preceding trial: 60 s after the three lightest loads, 90 s after the two heavier loads, and 120 s during the incremental trials leading to 1-RM. For each load, the mean concentric velocity of the best trial was used to establish the individual force-velocity (F-V) relationship using linear regression, from which the maximal power (Pmax; W) was estimated. |
Change from baseline at 6 and 12 weeks
|
|
Maximal isometric force (F0)
Tidsramme: Change from baseline at 6 and 12 weeks
|
Participants performed explosive unilateral leg extensions with the dominant leg at five submaximal loads on a pneumatic leg press (Leg Press Air 400, Keiser, USA). Submaximal loads were scaled to the estimated maximal isometric force derived from the familiarization session. The three lighter loads were performed three times each and the two heavier loads twice, with the repetition yielding the highest mean concentric velocity retained for analysis. Participants subsequently performed single repetitions at incrementally increasing loads until 1-RM was reached. Rest intervals were adjusted according to the load of the preceding trial: 60 s after the three lightest loads, 90 s after the two heavier loads, and 120 s during the incremental trials leading to 1-RM. For each load, the mean concentric velocity of the best trial was used to establish the individual force-velocity (F-V) relationship using linear regression, from which maximal isometric force (F0; N) was estimated. |
Change from baseline at 6 and 12 weeks
|
|
Maximal unloaded velocity (V0)
Tidsramme: Change from baseline at 6 and 12 weeks
|
Participants performed explosive unilateral leg extensions with the dominant leg at five submaximal loads on a pneumatic leg press (Leg Press Air 400, Keiser, USA). Submaximal loads were scaled to the estimated maximal isometric force derived from the familiarization session. The three lighter loads were performed three times each and the two heavier loads twice, with the repetition yielding the highest mean concentric velocity retained for analysis. Participants subsequently performed single repetitions at incrementally increasing loads until 1-RM was reached. Rest intervals were adjusted according to the load of the preceding trial: 60 s after the three lightest loads, 90 s after the two heavier loads, and 120 s during the incremental trials leading to 1-RM. For each load, the mean concentric velocity of the best trial was used to establish the individual force-velocity (F-V) relationship using linear regression, from which maximal unloaded velocity (V0; m/s) was estimated. |
Change from baseline at 6 and 12 weeks
|
|
Force-velocity slope
Tidsramme: Change from baseline at 6 and 12 weeks
|
Participants performed explosive unilateral leg extensions with the dominant leg at five submaximal loads on a pneumatic leg press (Leg Press Air 400, Keiser, USA). Submaximal loads were scaled to the estimated maximal isometric force derived from the familiarization session. The three lighter loads were performed three times each and the two heavier loads twice, with the repetition yielding the highest mean concentric velocity retained for analysis. Participants subsequently performed single repetitions at incrementally increasing loads until 1-RM was reached. Rest intervals were adjusted according to the load of the preceding trial: 60 s after the three lightest loads, 90 s after the two heavier loads, and 120 s during the incremental trials leading to 1-RM. For each load, the mean concentric velocity of the best trial was used to establish the individual force-velocity (F-V) relationship using linear regression, from which the F-V slope (Ns/m) was derived. |
Change from baseline at 6 and 12 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Short Physical Performance Battery (SPPB)
Tidsramme: Score at baseline
|
Total score on the SPPB (min 0, max 12, higher scores indicate better performance) |
Score at baseline
|
|
Hand grip strength
Tidsramme: Change from baseline at 6 and 12 weeks
|
Maximal grip strength (kg) of the dominant hand using an isometric dynamometer adjusted for hand size |
Change from baseline at 6 and 12 weeks
|
|
Maximal gait speed
Tidsramme: Change from baseline at 6 and 12 weeks
|
The average time (s) to walk 10m as fast as possible |
Change from baseline at 6 and 12 weeks
|
|
Countermovement jump
Tidsramme: Change from baseline at 6 and 12 weeks
|
The jump height (mm) in a countermovement jump |
Change from baseline at 6 and 12 weeks
|
|
Timed up-and-go
Tidsramme: Change from baseline at 6 and 12 weeks
|
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 at 6 and 12 weeks
|
|
5-repetition sit-to-stand time
Tidsramme: Change from baseline at 6 and 12 weeks
|
The time (s) needed to complete the 5-repetition sit-to-stand test |
Change from baseline at 6 and 12 weeks
|
|
5-repetition sit-to-stand power
Tidsramme: Change from baseline at 6 and 12 weeks
|
The average power (watt) produced during the 5-repetition sit-to-stand test |
Change from baseline at 6 and 12 weeks
|
|
30-second sit-to-stand repetitions
Tidsramme: Change from baseline at 6 and 12 weeks
|
The number of repetitions completed during the 30-second sit-to-stand test |
Change from baseline at 6 and 12 weeks
|
|
30-second sit-to-stand power
Tidsramme: Change from baseline at 6 and 12 weeks
|
The average power (watt) produced during the 30-second sit-to-stand test |
Change from baseline at 6 and 12 weeks
|
|
Stair ascent time
Tidsramme: Change from baseline at 6 and 12 weeks
|
The time (s) needed to ascend a flight of stairs |
Change from baseline at 6 and 12 weeks
|
|
Stair ascent power
Tidsramme: Change from baseline at 6 and 12 weeks
|
The average power (Watt) produced during the stair ascent test |
Change from baseline at 6 and 12 weeks
|
|
Exercise adherence
Tidsramme: Total adherence over 12-week period
|
Number of sessions attended as a percentage of total sessions planned |
Total adherence over 12-week period
|
|
Absolute training load
Tidsramme: Consistently recorded throughout the 12-week intervention
|
The absolute load (kg) used during training sessions |
Consistently recorded throughout the 12-week intervention
|
|
Relative training load
Tidsramme: Consistently recorded throughout the 12-week intervention
|
The relative load (%1RM) used during training sessions |
Consistently recorded throughout the 12-week intervention
|
|
Number of repetitions
Tidsramme: Consistently recorded throughout the 12-week intervention
|
The number of repetitions (n) completed per set |
Consistently recorded throughout the 12-week intervention
|
|
Highest movement velocity within a set
Tidsramme: Consistently recorded throughout the 12-week intervention
|
The velocity (m/s) of the fastest repetition in a set (Vmax) |
Consistently recorded throughout the 12-week intervention
|
|
Lowest movement velocity within a set
Tidsramme: Consistently recorded throughout the 12-week intervention
|
The velocity (m/s) of the slowest repetition in a set (Vmin) |
Consistently recorded throughout the 12-week intervention
|
|
Velocity loss
Tidsramme: Consistently recorded throughout the 12-week intervention
|
The percentage difference between the highest and lowest movement velocity in a set = ([Vmax - Vmin] / Vmax) × 100 |
Consistently recorded throughout the 12-week intervention
|
|
Set-volume index
Tidsramme: Consistently recorded throughout the 12-week intervention
|
The number of repetitions × relative load (%1-RM) per set |
Consistently recorded throughout the 12-week intervention
|
|
Session-volume index
Tidsramme: Consistently recorded throughout the 12-week intervention
|
The sum of set volumes per session |
Consistently recorded throughout the 12-week intervention
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- S68434
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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