Capital University of Physical Education and Sports, Beijing
Beijing, China
NCT Number: NCT07551206
This four-arm randomized pilot trial (N=48-60) compares four fragmentation patterns of a three-exercise resistance snack (sit-to-stand, squat, heel raise; 15 repetitions/exercise/day) in pre-frail older adults (Fried score 1-2, ≥70 years). Groups differ by repetitions/bout×bouts/day: G1=1×15, G2=3×5, G3=5×3, G4=15×1. Outcomes (lower limb strength, balance, executive function) are assessed at baseline, week 4, and week 8. The study will determine the optimal fragmentation pattern and provide effect sizes for a future definitive trial.
Trial opening soon.
Get Notified65 year and older
Male
Interventional
Not applicable
Beijing, China
This is a four-arm, parallel-group, randomized controlled pilot trial. Forty-eight to sixty community-dwelling pre-frail older adults (Fried frailty phenotype score 1-2, aged ≥70 years) will be randomly assigned to one of four groups (1:1:1:1 ratio). All groups perform a fixed total daily volume of 15 repetitions per exercise (sit-to-stand, squat, and heel raise), resulting in 45 total repetitions per day. The only difference between groups is the fragmentation pattern (i.e., repetitions per bout × bouts per day):
G1 (highly fragmented): 1 repetition of each exercise per bout, 15 bouts/day (~30 seconds per bout)
G2 (moderately fragmented): 3 repetitions of each exercise per bout, 5 bouts/day (~90 seconds per bout)
G3 (lowly fragmented): 5 repetitions of each exercise per bout, 3 bouts/day (~2.5 minutes per bout)
G4 (consecutive control): 15 repetitions of each exercise per bout, 1 bout/day (~7.5 minutes per bout)
The intervention period is 8 weeks. Outcomes are assessed at baseline, mid-intervention (week 4), and post-intervention (week 8). Primary outcomes include lower limb strength (30-second chair stand test) and dynamic balance (Timed Up and Go test). Secondary outcomes include comprehensive physical function (Short Physical Performance Battery), executive function (Stroop Color-Word Test and Trail Making Test), falls efficacy (modified Falls Efficacy Scale), adherence, acceptability, and adverse events.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in Arm 1 perform a resistance-based exercise snack consisting of three exercises: sit-to-stand, squat, and heel raise. Each bout contains 1 repetition of each exercise (1-1-1 structure). Participants complete 15 bouts per day, with each bout taking approximately 30 seconds. The total daily volume is 15 repetitions per exercise (45 total repetitions). The intervention period is 8 weeks. Participants are instructed to use event-based triggers (e.g., after each bathroom visit or after drinking water) to initiate each bout. A demonstration video and a daily exercise log are provided.
Other names: Arm 1
Participants in Arm 2 perform a resistance-based exercise snack consisting of three exercises: sit-to-stand, squat, and heel raise. Each bout contains 3 repetitions of each exercise (3-3-3 structure). Participants complete 5 bouts per day, with each bout taking approximately 90 seconds. The total daily volume is 15 repetitions per exercise (45 total repetitions). The intervention period is 8 weeks. Participants are instructed to perform bouts at fixed time points (e.g., morning, mid-morning, noon, afternoon, evening). A demonstration video and a daily exercise log are provided.
Other names: Arm 2
Participants in Arm 3 perform a resistance-based exercise snack consisting of three exercises: sit-to-stand, squat, and heel raise. Each bout contains 5 repetitions of each exercise (5-5-5 structure). Participants complete 3 bouts per day, with each bout taking approximately 2.5 minutes. The total daily volume is 15 repetitions per exercise (45 total repetitions). The intervention period is 8 weeks. Participants are instructed to perform bouts at three fixed time points (e.g., morning, noon, evening). A demonstration video and a daily exercise log are provided.
Other names: Arm 3
Participants in Arm 4 perform a resistance-based exercise session consisting of three exercises: sit-to-stand, squat, and heel raise. Each bout contains 15 repetitions of each exercise (15-15-15 structure). Participants complete 1 bout per day, with the bout taking approximately 7.5 minutes. The total daily volume is 15 repetitions per exercise (45 total repetitions). The intervention period is 8 weeks. Participants are instructed to perform the bout at a fixed time each day (e.g., 10:00 AM). A demonstration video and a daily exercise log are provided.
Other names: Arm 4
Time frame: Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8)
Measured by the 30-Second Chair Stand Test (30-CST). The number of times a participant can stand up from a sitting position and sit back down within 30 seconds. A higher score indicates better lower limb strength.
Time frame: Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8)
Measured by the Timed Up and Go (TUG) test. The time (in seconds) taken to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. A shorter time indicates better dynamic balance and mobility.
Contact information is provided by the study sponsor or research team.
Capital University of Physical Education and Sports, China
Other
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