Effects of Exercise on Older AdultsNCT07551206
Effects of Resistance-based Exercise Snacks With Varying Fragmentation Patterns on Lower Limb Function and Executive Cognition in Pre-frail Older Adults
A study testing Highly Fragmented Exercise Snack, Moderately Fragmented Exercise Snack and Lowly Fragmented Exercise Snack in people with Effects of Exercise on Older Adults, run by Capital University of Physical Education and Sports, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Effects of Exercise on Older Adults
- What is being tested?
- Highly Fragmented Exercise Snack, Moderately Fragmented Exercise Snack and Lowly Fragmented Exercise Snack
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Capital University of Physical Education and Sports, Beijing
Beijing
yongzhao fan, PHD, China：13051065318, fanyongzhao@cupes.edu.cn
About this study
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.
Read the 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.
- Conditions
- Effects of Exercise on Older Adults
- Being tested
- Highly Fragmented Exercise Snack, Moderately Fragmented Exercise Snack, Lowly Fragmented Exercise Snack, Consecutive Exercise (Active Control)
- Keywords
- Exercise snacks, Resistance training, Pre-frail older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Highly Fragmented Exercise SnackBehavioural
Also called Arm 1
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.
Moderately Fragmented Exercise SnackBehavioural
Also called Arm 2
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.
Lowly Fragmented Exercise SnackBehavioural
Also called Arm 3
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.
Consecutive Exercise (Active Control)Behavioural
Also called Arm 4
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Consecutive Exercise (Active Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion5 Aug 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of Exercise on Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital University of Physical Education and Sports, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongzhao Fan, Capital University of Physical Education and Sports, China
- Investigators
- yongzhao fan, Study director, Capital University of Physical Education And Sports
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551206
- Sponsor's protocol ID
- CUPES-PY-2026420
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance-based Exercise Snacks With Varying Fragmentation Patterns on Lower Limb Function and Executive Cognition in Pre-frail Older Adults
- ClinicalTrials.gov ID
- NCT07551206
- Acronym / sponsor ID
- CUPES-PY-2026420
- Conditions
- Effects of Exercise on Older Adults
- Keywords
- Exercise snacks, Resistance training, Pre-frail older adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Capital University of Physical Education and Sports, ChinaUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 5 Aug 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1：Highly Fragmented Exercise Snack Group | Experimental | Behavioral: Highly Fragmented Exercise SnackArm 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 | Experimental | Behavioral: Moderately Fragmented Exercise SnackArm 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 | Experimental | Behavioral: Lowly Fragmented Exercise SnackArm 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 | Experimental | Behavioral: Consecutive Exercise (Active Control)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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Highly Fragmented Exercise SnackAlso: Arm 1Participants 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. | Behavioural | Arm 1：Highly Fragmented Exercise Snack Group |
| Moderately Fragmented Exercise SnackAlso: Arm 2Participants 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. | Behavioural | Arm 2：Moderately Fragmented Exercise Snack Group |
| Lowly Fragmented Exercise SnackAlso: Arm 3Participants 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. | Behavioural | Arm 3：Lowly Fragmented Exercise Snack Group |
| Consecutive Exercise (Active Control)Also: Arm 4Participants 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. | Behavioural | Arm 4：Consecutive Control Group |
Primary outcome
Lower Limb Muscle Strength
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.
Dynamic Balance and Mobility
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
yongzhao fan study director
Capital University of Physical Education And Sports
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Highly Fragmented Exercise Snack, Moderately Fragmented Exercise Snack and Lowly Fragmented Exercise Snack in people with Effects of Exercise on Older Adults, run by Capital University of Physical Education and Sports, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yongzhao fan, PHD (China：13051065318, fanyongzhao@cupes.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Limb Muscle Strength (time frame: Baseline (Week 0), Mid-intervention (Week 4), Post-intervention (Week 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.