Effects of Resistance-based Exercise Snacks With Varying Fragmentation Patterns on Lower Limb Function and Executive Cognition in Pre-frail Older Adults
1 other identifier
interventional
60
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2026
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
April 19, 2026
CompletedFirst Posted
Study publicly available on registry
April 24, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 15, 2026
April 24, 2026
April 1, 2026
3 months
April 19, 2026
April 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
Study Arms (4)
Arm 1:Highly Fragmented Exercise Snack Group
EXPERIMENTALArm 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.
Arm 2:Moderately Fragmented Exercise Snack Group
EXPERIMENTALArm 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.
Arm 3:Lowly Fragmented Exercise Snack Group
EXPERIMENTALArm 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.
Arm 4:Consecutive Control Group
EXPERIMENTALArm 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.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- \. 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
You may not qualify if:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Capital University of Physical Education and Sports, Beijing
Beijing, China
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
yongzhao fan
Capital University of Physical Education And Sports
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 19, 2026
First Posted
April 24, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
August 5, 2026
Study Completion (Estimated)
August 15, 2026
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP
- Time Frame
- 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.
- Access Criteria
- 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.
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.