NCT07551206

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

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress43%
May 2026Aug 2026

First Submitted

Initial submission to the registry

April 19, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2026

Expected
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 19, 2026

Last Update Submit

April 19, 2026

Conditions

Keywords

Exercise snacksResistance trainingPre-frail older adults

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

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.

Behavioral: Highly Fragmented Exercise Snack

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.

Behavioral: Moderately Fragmented Exercise Snack

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.

Behavioral: Lowly Fragmented Exercise Snack

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.

Behavioral: Consecutive Exercise (Active Control)

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.

Also known as: Arm 1
Arm 1:Highly Fragmented Exercise Snack Group

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.

Also known as: Arm 2
Arm 2:Moderately Fragmented Exercise Snack Group

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.

Also known as: Arm 3
Arm 3:Lowly Fragmented Exercise Snack Group

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.

Also known as: Arm 4
Arm 4:Consecutive Control Group

Eligibility Criteria

Age65 Years+
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

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

Location

Related Links

MeSH Terms

Interventions

DMAC2L protein, human

Study Officials

  • yongzhao fan

    Capital University of Physical Education And Sports

    STUDY DIRECTOR

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
Model 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.
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

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.

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.
More information

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