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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1:Highly Fragmented Exercise Snack Group | Experimental | Arm 1:Participants perform 1 repetition of each exercise (sit-to-stand, squat, and heel raise) per bout, 15 bouts per day, for 8 weeks. Each bout takes approximately 30 seconds. |
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| Arm 2:Moderately Fragmented Exercise Snack Group | Experimental | Arm 2:Participants perform 3 repetitions of each exercise (sit-to-stand, squat, and heel raise) per bout, 5 bouts per day, for 8 weeks. Each bout takes approximately 90 seconds. |
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| Arm 3:Lowly Fragmented Exercise Snack Group | Experimental | Arm 3:Participants perform 5 repetitions of each exercise (sit-to-stand, squat, and heel raise) per bout, 3 bouts per day, for 8 weeks. Each bout takes approximately 2.5 minutes. |
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| Arm 4:Consecutive Control Group | Experimental | Arm 4:Participants perform 15 repetitions of each exercise (sit-to-stand, squat, and heel raise) per bout, 1 bout per day, for 8 weeks. Each bout takes approximately 7.5 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Highly Fragmented Exercise Snack | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Lower Limb Muscle Strength | 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. | Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8) |
| Dynamic Balance and Mobility | 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. | Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yongzhao fan, PHD | Contact | China:13051065318 | fanyongzhao@cupes.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| yongzhao fan | Capital University of Physical Education And Sports | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital University of Physical Education and Sports, Beijing | Beijing | China |
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| Label | URL |
|---|---|
| Related Info | View source |
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The individual participant data (IPD) from this study, including anonymized performance metrics, physiological responses, and metabolic data, will be shared with other researchers upon reasonable request. Data will be provided in accordance with applicable ethical and regulatory guidelines to ensure the privacy and confidentiality of study participants. Requests for data access can be made by contacting the principal investigator,Fanyongzhao, at fanyongzhao@cupes.edu.cn.
The IPD and supporting information will be made available starting from 6 months after the publication of the study results and will remain available for 5 years.
The IPD and supporting information will be available to qualified researchers upon request. Access will be granted after a data-sharing agreement is signed to ensure the data will be used responsibly and in accordance with ethical guidelines. Researchers can request access by contacting the Principal Investigator at fanyongzhao@cupes.edu.cn.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 10, 2026 | Apr 19, 2026 |
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This is a four-arm, parallel-group, randomized controlled pilot trial. 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.
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This is a four-arm, parallel-group, randomized controlled pilot trial. 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.
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| Moderately Fragmented Exercise Snack | Behavioral | 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. |
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| Lowly Fragmented Exercise Snack | Behavioral | 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. |
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| Consecutive Exercise (Active Control) | Behavioral | 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. |
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| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 10, 2026 | Apr 19, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| C000608097 | DMAC2L protein, human |
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