- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07551206
Effects of Resistance-based Exercise Snacks With Varying Fragmentation Patterns on Lower Limb Function and Executive Cognition in Pre-frail Older Adults
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: yongzhao fan, PHD
- Phone Number: China:13051065318
- Email: fanyongzhao@cupes.edu.cn
Study Locations
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Beijing, China
- Capital University of Physical Education and Sports, Beijing
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Contact:
- yongzhao fan, PHD
- Phone Number: China:13051065318
- Email: fanyongzhao@cupes.edu.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1. Age 65 years or older 2. Community-dwelling (living independently, not in a nursing home or long-term care facility) 3. Pre-frail status confirmed by Fried Frailty Phenotype score of 1-2 4. Mini-Mental State Examination (MMSE) score ≥24 5. Able to walk independently with or without a cane 6. No regular lower limb strength training (less than 2 times per week) in the past 3 months 7. Willing to adhere to the 8-week exercise intervention and complete all assessments 8. Provide written informed consent before any study-related procedures
Exclusion Criteria:
- 1. Lower limb fracture or joint replacement surgery within the past 6 months 2. Unstable angina or uncontrolled hypertension (resting systolic blood pressure ≥160 mmHg) 3. Severe osteoporosis (T-score <-2.5 with history of fragility fracture) 4. Neurological disorders affecting motor function (e.g., Parkinson's disease, post-stroke hemiplegia) 5. Severe cognitive impairment (MMSE score <24) 6. Unstable cardiac or pulmonary disease (e.g., recent myocardial infarction, severe COPD exacerbation) 7. Severe visual or hearing impairment that limits ability to follow instructions or perform exercises safely 8. Participation in another interventional clinical trial within the past 30 days 9. Any other medical or psychological condition that, in the opinion of the principal investigator, would compromise participant safety or study adherence
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1:Highly Fragmented Exercise Snack Group
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.
|
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:
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|
Experimental: Arm 2:Moderately Fragmented Exercise Snack Group
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.
|
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:
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Experimental: Arm 3:Lowly Fragmented Exercise Snack Group
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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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:
|
|
Experimental: Arm 4:Consecutive Control Group
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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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Lower Limb Muscle Strength
Time Frame: Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8)
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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.
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Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8)
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Dynamic Balance and Mobility
Time Frame: Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8)
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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.
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Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8)
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Collaborators and Investigators
Investigators
- Study Director: yongzhao fan, Capital University of Physical Education And Sports
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CUPES-PY-2026420
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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