RehabilitationNCT06155227
Blood Flow Restriction With Aerobic Exercise in Frail Older Adults
A study testing aerobic exercise combined with blood flow restriction and aerobic exercise in people with Rehabilitation, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
Background:Frailty is most often defined as a syndrome of physiological decline in late life, characterized by marked vulnerability to adverse health outcomes. Exercise intervention including aerobic exercise training has been proven to be effective in improving aerobic capacity and frail condition in elderly. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Rehabilitation
- What is being tested?
- aerobic exercise combined with blood flow restriction and aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Dec 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- more than one positive item of Fried frailty phenotype assessment
- able to walk more than 8 meters independently
- can understand and follow more than three-step order
Who cannot join
- severe hypertension (>160/100 mmHg)
- cardiovascular disease, such as myocardial infarction, New York Heart Association class III or IV heart failure, pulmonary hypertension
- deep vein thrombosis or peripheral vascular disease
- peripheral neuropathy due to diabetes
- neuromuscular diseases, such as stroke, Parkinson's disease, etc.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Physical Therapy
Tainan, 701
Pei-Yun Lee, PhD, 886-6-235353 ext. 5936, peiyunlee@mail.ncku.edu.tw
About this study
Official title: Effect of Aerobic Exercise Combined With Blood Flow Restriction on Cardiopulmonary Function and Functional Activities in Frail Older Adults
Background:Frailty is most often defined as a syndrome of physiological decline in late life, characterized by marked vulnerability to adverse health outcomes. Exercise intervention including aerobic exercise training has been proven to be effective in improving aerobic capacity and frail condition in elderly. Recently a novel training method using blood flow restriction (BFR) combined with aerobic exercise has shown positive effects on muscles strength and physical function in healthy elderly. This training method only required lower exercise intensity compared with traditional aerobic exercise to observe improvement. However, it is still unclear whether aerobic exercise training combined with BFR could also improve aerobic capacity and physical function in frail older adults. Therefore, the aim of this study will be to investigate the effect of aerobic exercise combined with BFR on cardiopulmonary function and functional activities in frail older adults.
Method: This study will be an assessor-blind randomized controlled trial.Participants aged over 65 years old with more than one item positive of Fried frailty phenotype assessment results will be recruited from the hospital and nearby communities. The participants will be randomly assigned to one of two training groups, aerobic exercise with BFR and only aerobic exercise. The exercise will be executed 30 minutes/session, three sessions/week for six weeks. Cardiopulmonary function and performance of functional activities will be assessed at pre-training, 3 weeks after training, post-training, and 3- and 6-week follow-up.
- Conditions
- Rehabilitation
- Being tested
- aerobic exercise combined with blood flow restriction, aerobic exercise
- Keywords
- Blood flow restriction, Aerobic exercise, Frailty, Elderly
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise combined with blood flow restrictionOther
aerobic exercise combined with blood flow restriction for 18 sessions
aerobic exerciseOther
aerobic exercise for 18 sessions
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Other: aerobic exercise combined with blood flow restriction |
| Control Group | Active comparator | Not described Receives: Other: aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity muscle strength
Use an hand-held dynamometer to measure bilateral lower limb muscle strength
Measured: Before training
Lower extremity muscle strength
Use an hand-held dynamometer to measure bilateral lower limb muscle strength
Measured: After completing three-week training
Lower extremity muscle strength
Use an hand-held dynamometer to measure bilateral lower limb muscle strength
Measured: After completing six-week training
Lower extremity muscle strength
Use an hand-held dynamometer to measure bilateral lower limb muscle strength
Measured: At three weeks after completing the training
Lower extremity muscle strength
Use an hand-held dynamometer to measure bilateral lower limb muscle strength
Measured: At six weeks after completing the training
Pulmonary function
Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second
Measured: Before training
Pulmonary function
Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second
Measured: After completing three-week training
Pulmonary function
Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second
Measured: After completing six-week training
Pulmonary function
Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second
Measured: At three weeks after completing the training
Pulmonary function
Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second
Measured: At six weeks after completing the training
Timed up and go test
This test measure the time taken by an individual to stand up from a chair , walk 3 meters, turn, walk back to the chair, and sit down
Measured: Before training
Timed up and go test
This test measures the time taken by an individual to stand up from a chair , walk 3 meters, turn, walk back to the chair, and sit down
Measured: After completing three-week training
Timed up and go test
This test measures the time taken by an individual to stand up from a chair , walk 3 meters, turn, walk back to the chair, and sit down
Measured: After completing six-week training
Timed up and go test
This test measure the time taken by an individual to stand up from a chair , walk 3 meters, turn, walk back to the chair, and sit down
Measured: At three weeks after completing the training
Timed up and go test
This test measure the time taken by an individual to stand up from a chair , walk 3 meters, turn, walk back to the chair, and sit down
Measured: At six weeks after completing the training
2 minutes step test
Number of steps completed in 2 min
Measured: Before training
2 minutes step test
Number of steps completed in 2 min
Measured: After completing three-week training
2 minutes step test
Number of steps completed in 2 min
Measured: After completing six-week training
2 minutes step test
Number of steps completed in 2 min
Measured: At three weeks after completing the training
2 minutes step test
Number of steps completed in 2 min
Measured: At six weeks after completing the training
6 minutes walking test
Record the distance walked in 6 minutes
Measured: Before training
6 minutes walking test
Record the distance walked in 6 minutes
Measured: After completing three-week training
6 minutes walking test
Record the distance walked in 6 minutes
Measured: After completing six-week training
6 minutes walking test
Record the distance walked in 6 minutes
Measured: At three weeks after completing the training
6 minutes walking test
Record the distance walked in 6 minutes
Measured: At six weeks after completing the training
Walking speed
Test the gait speed under preferred and maximum speed walking
Measured: Before training
Walking speed
Test the gait speed under preferred and maximum speed walking
Measured: After completing three-week training
Walking speed
Test the gait speed under preferred and maximum speed walking
Measured: After completing six-week training
Walking speed
Test the gait speed under preferred and maximum speed walking
Measured: At three weeks after completing the training
Walking speed
Test the gait speed under preferred and maximum speed walking
Measured: At six weeks after completing the training
Secondary outcomes (4)
Body composition
Use Inbody 270 to measure skeletal muscle mass of the whole body and the four extremities
Measured: Before training
Body composition
Use Inbody 270 to measure skeletal muscle mass of the whole body and the four extremities
Measured: After completing six-week training
Body composition
Use Inbody 270 to measure skeletal muscle mass of the whole body and the four extremities
Measured: At three weeks after completing the training
Body composition
Use Inbody 270 to measure skeletal muscle mass of the whole body and the four extremities
Measured: At six weeks after completing the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start20 Dec 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pei-Yun Lee, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155227
- Sponsor's protocol ID
- B-ER-112-370
- Status last verified
- Dec 2023
- First submitted
- 23 Nov 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercise Combined With Blood Flow Restriction on Cardiopulmonary Function and Functional Activities in Frail Older Adults
- ClinicalTrials.gov ID
- NCT06155227
- Acronym / sponsor ID
- B-ER-112-370
- Conditions
- Rehabilitation
- Keywords
- Blood flow restriction, Aerobic exercise, Frailty, Elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Dec 2023 (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.
Background:Frailty is most often defined as a syndrome of physiological decline in late life, characterized by marked vulnerability to adverse health outcomes. Exercise intervention including aerobic exercise training has been proven to be effective in improving aerobic capacity and frail condition in elderly. Recently a novel training method using blood flow restriction (BFR) combined with aerobic exercise has shown positive effects on muscles strength and physical function in healthy elderly. This training method only required lower exercise intensity compared with traditional aerobic exercise to observe improvement. However, it is still unclear whether aerobic exercise training combined with BFR could also improve aerobic capacity and physical function in frail older adults. Therefore, the aim of this study will be to investigate the effect of aerobic exercise combined with BFR on cardiopulmonary function and functional activities in frail older adults.
Method: This study will be an assessor-blind randomized controlled trial.Participants aged over 65 years old with more than one item positive of Fried frailty phenotype assessment results will be recruited from the hospital and nearby communities. The participants will be randomly assigned to one of two training groups, aerobic exercise with BFR and only aerobic exercise. The exercise will be executed 30 minutes/session, three sessions/week for six weeks. Cardiopulmonary function and performance of functional activities will be assessed at pre-training, 3 weeks after training, post-training, and 3- and 6-week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: aerobic exercise combined with blood flow restriction |
| Control Group | Active comparator | Other: aerobic exercise |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- more than one positive item of Fried frailty phenotype assessment
- able to walk more than 8 meters independently
- can understand and follow more than three-step order
Key exclusion criteria (5 listed)
- severe hypertension (>160/100 mmHg)
- cardiovascular disease, such as myocardial infarction, New York Heart Association class III or IV heart failure, pulmonary hypertension
- deep vein thrombosis or peripheral vascular disease
- peripheral neuropathy due to diabetes
- neuromuscular diseases, such as stroke, Parkinson's disease, etc.
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 |
|---|---|---|
| aerobic exercise combined with blood flow restrictionaerobic exercise combined with blood flow restriction for 18 sessions | Other | Experimental Group |
| aerobic exerciseaerobic exercise for 18 sessions | Other | Control Group |
Primary outcome
Lower extremity muscle strength
Time frame: Before training
Use an hand-held dynamometer to measure bilateral lower limb muscle strength
Lower extremity muscle strength
Time frame: After completing three-week training
Use an hand-held dynamometer to measure bilateral lower limb muscle strength
Lower extremity muscle strength
Time frame: After completing six-week training
Use an hand-held dynamometer to measure bilateral lower limb muscle strength
Lower extremity muscle strength
Time frame: At three weeks after completing the training
Use an hand-held dynamometer to measure bilateral lower limb muscle strength
Lower extremity muscle strength
Time frame: At six weeks after completing the training
Use an hand-held dynamometer to measure bilateral lower limb muscle strength
Pulmonary function
Time frame: Before training
Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second
Pulmonary function
Time frame: After completing three-week training
Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second
Pulmonary function
Time frame: After completing six-week training
Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second
Pulmonary function
Time frame: At three weeks after completing the training
Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second
Pulmonary function
Time frame: At six weeks after completing the training
Pulmonary function includes tidal volume, vital capacity, forced vital capacity, and forced expiratory volume in one second
Timed up and go test
Time frame: Before training
This test measure the time taken by an individual to stand up from a chair , walk 3 meters, turn, walk back to the chair, and sit down
Timed up and go test
Time frame: After completing three-week training
This test measures the time taken by an individual to stand up from a chair , walk 3 meters, turn, walk back to the chair, and sit down
Timed up and go test
Time frame: After completing six-week training
This test measures the time taken by an individual to stand up from a chair , walk 3 meters, turn, walk back to the chair, and sit down
Timed up and go test
Time frame: At three weeks after completing the training
This test measure the time taken by an individual to stand up from a chair , walk 3 meters, turn, walk back to the chair, and sit down
Timed up and go test
Time frame: At six weeks after completing the training
This test measure the time taken by an individual to stand up from a chair , walk 3 meters, turn, walk back to the chair, and sit down
2 minutes step test
Time frame: Before training
Number of steps completed in 2 min
2 minutes step test
Time frame: After completing three-week training
Number of steps completed in 2 min
2 minutes step test
Time frame: After completing six-week training
Number of steps completed in 2 min
2 minutes step test
Time frame: At three weeks after completing the training
Number of steps completed in 2 min
2 minutes step test
Time frame: At six weeks after completing the training
Number of steps completed in 2 min
6 minutes walking test
Time frame: Before training
Record the distance walked in 6 minutes
6 minutes walking test
Time frame: After completing three-week training
Record the distance walked in 6 minutes
6 minutes walking test
Time frame: After completing six-week training
Record the distance walked in 6 minutes
6 minutes walking test
Time frame: At three weeks after completing the training
Record the distance walked in 6 minutes
6 minutes walking test
Time frame: At six weeks after completing the training
Record the distance walked in 6 minutes
Walking speed
Time frame: Before training
Test the gait speed under preferred and maximum speed walking
Walking speed
Time frame: After completing three-week training
Test the gait speed under preferred and maximum speed walking
Walking speed
Time frame: After completing six-week training
Test the gait speed under preferred and maximum speed walking
Walking speed
Time frame: At three weeks after completing the training
Test the gait speed under preferred and maximum speed walking
Walking speed
Time frame: At six weeks after completing the training
Test the gait speed under preferred and maximum speed walking
4 secondary outcomes
Body composition
Time frame: Before training
Body composition
Time frame: After completing six-week training
Body composition
Time frame: At three weeks after completing the training
Body composition
Time frame: At six weeks after completing the training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise combined with blood flow restriction and aerobic exercise in people with Rehabilitation, run by National Cheng Kung University at 1 site in Taiwan.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Dec 2023. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pei-Yun Lee, PhD (886-6-2353535 ext. 5936, peiyunlee@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower extremity muscle strength (time frame: Before training). The study lists 30 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 26 Dec 2023.