FrailtyNCT04507152
Blood Flow Restriction Training in Pre-frail and Frail Older Adults
A study testing Blood flow restriction resistance training and Resistance training in people with Frailty, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
Frailty is most often defined as a syndrome of physiological decline in late life, characterized by marked vulnerability to adverse health outcomes. Intervention such as exercise, especially resistance exercise, has proven to be effective to improve frail condition in the elderly in the previous literature. Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Frailty
- What is being tested?
- Blood flow restriction resistance training and Resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Aug 2020to 26 Nov 2021
- 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 60 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged over 60 years old
- Fried frailty index fulfill 1-2 criteria
- Able to walk 6 meters independently
- Able to understand and follow ≥ 3 instructions
Who cannot join
- Severe hypertension (>180/110mmHg)
- Peripheral neuropathy
- History of deep-vein thrombosis (DVT)
- Cardiovascular diseases (i.e. Heart failure NYHA Classification III or IV, myocardial infarction, pulmonary hypertension, coronary artery stenosis)
- Neuromuscular diseases (i.e. Stroke, Parkinsons' disease)
- History of resisted exercise training program within the last 6 months before screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Blood Flow Restriction Resistance Training on Muscle Strength and Functional Performance in Frail Older Adults
Frailty is most often defined as a syndrome of physiological decline in late life, characterized by marked vulnerability to adverse health outcomes. Intervention such as exercise, especially resistance exercise, has proven to be effective to improve frail condition in the elderly in the previous literature. However, blood flow restriction (BFR) training, a new resistance exercise training method, need merely lower resistance power and shorter training duration compared with traditional resistance exercise. Previous researches also demonstrated BFR can increase muscle mass and muscle strength in the healthy elderly but the effect of BFR training on the pre-frail or frail elderly is unknown. The aim of this study will test the effect of BFR training on muscle strength and functional performance in pre-frail or frail elderly. Participants aged over 60 years old with clinical frailty score between 3 to 5 will be recruited. Participants will be assigned to two groups using randomized block design with BFR training and control group. Structured questionnaire and physical function measurement will be used to assess the pre-intervention condition and outcome of different interventions. The participants will be assessed before training (pre-test), 3 weeks after training, and 6 weeks after training (post-test), and followed up at one and three months after training. Physical function measurement will include hand grip, muscle mass over trunk and extremity, muscle strength of lower extremity, gait speed and timed up and go test. Two-way repeated measures analysis of variance will be used to test the pre-test, 3-week, post-test and follow-ups difference between the two groups.
- Conditions
- Frailty
- Being tested
- Blood flow restriction resistance training, Resistance training
- Keywords
- Blood flow restriction, Resistance exercise, Frailty
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction resistance trainingOther
The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The experimental group will execute the training with blood flow restriction.
Resistance trainingOther
The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The control group will execute the training without blood flow restriction.
| Study group | Role | What they receive |
|---|---|---|
| Blood flow restriction resistance training | Experimental | Not described Receives: Other: Blood flow restriction resistance training |
| Resistance training | Active comparator | Not described Receives: Other: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of muscle strength of the lower extremities
Bilateral hip flexors, knee extensors, ankle dorsiflexors and ankle plantarflexors
Measured: Before training, 3 and 6 weeks after training, and one and two months follow-ups
Change of 30 seconds sit to stand
30 seconds sit to stand
Measured: Before training, 3 and 6 weeks after training, and one and two months follow-ups
Change of timed-up-and-go test
Timed-up-and-go test
Measured: Before training, 3 and 6 weeks after training, and one and two months follow-ups
Secondary outcomes (4)
Change of one-repetition maximum
One-repetition maximum of step-ups
Measured: Before training, 3 and 6 weeks after training, and one and two months follow-ups
Change of muscle mass
Muscle mass of the upper and lower extremities and trunk
Measured: Before training, 3 and 6 weeks after training, and one and two months follow-ups
Change of hand grip
Bilateral hand grip strength
Measured: Before training, 3 and 6 weeks after training, and one and two months follow-ups
Change of physical activity level
The International Physical Activity Questionnaire (IPAQ)
Measured: Before training, 3 and 6 weeks after training, and one and two months follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start5 Aug 2020
- Primary completion26 Nov 2021
- Study completion26 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies 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
- 26 participants (actual)
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
- NCT04507152
- Sponsor's protocol ID
- A-BR-108-111-T
- Status last verified
- Jan 2022
- First submitted
- 4 Aug 2020
- Last updated
- 11 Jan 2022
- 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 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Blood Flow Restriction Resistance Training on Muscle Strength and Functional Performance in Frail Older Adults
- ClinicalTrials.gov ID
- NCT04507152
- Acronym / sponsor ID
- A-BR-108-111-T
- Conditions
- Frailty
- Keywords
- Blood flow restriction, Resistance exercise, Frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 26 Nov 2021 (actual)
- Study completion
- 26 Nov 2021 (actual)
- First posted
- 11 Aug 2020 (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.
Frailty is most often defined as a syndrome of physiological decline in late life, characterized by marked vulnerability to adverse health outcomes. Intervention such as exercise, especially resistance exercise, has proven to be effective to improve frail condition in the elderly in the previous literature. However, blood flow restriction (BFR) training, a new resistance exercise training method, need merely lower resistance power and shorter training duration compared with traditional resistance exercise. Previous researches also demonstrated BFR can increase muscle mass and muscle strength in the healthy elderly but the effect of BFR training on the pre-frail or frail elderly is unknown. The aim of this study will test the effect of BFR training on muscle strength and functional performance in pre-frail or frail elderly. Participants aged over 60 years old with clinical frailty score between 3 to 5 will be recruited. Participants will be assigned to two groups using randomized block design with BFR training and control group. Structured questionnaire and physical function measurement will be used to assess the pre-intervention condition and outcome of different interventions. The participants will be assessed before training (pre-test), 3 weeks after training, and 6 weeks after training (post-test), and followed up at one and three months after training. Physical function measurement will include hand grip, muscle mass over trunk and extremity, muscle strength of lower extremity, gait speed and timed up and go test. Two-way repeated measures analysis of variance will be used to test the pre-test, 3-week, post-test and follow-ups difference between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction resistance training | Experimental | Other: Blood flow restriction resistance training |
| Resistance training | Active comparator | Other: Resistance training |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged over 60 years old
- Fried frailty index fulfill 1-2 criteria
- Able to walk 6 meters independently
- Able to understand and follow ≥ 3 instructions
Key exclusion criteria (6 listed)
- Severe hypertension (>180/110mmHg)
- Peripheral neuropathy
- History of deep-vein thrombosis (DVT)
- Cardiovascular diseases (i.e. Heart failure NYHA Classification III or IV, myocardial infarction, pulmonary hypertension, coronary artery stenosis)
- Neuromuscular diseases (i.e. Stroke, Parkinsons' disease)
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 |
|---|---|---|
| Blood flow restriction resistance trainingThe participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The experimental group will execute the training with blood flow restriction. | Other | Blood flow restriction resistance training |
| Resistance trainingThe participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The control group will execute the training without blood flow restriction. | Other | Resistance training |
Primary outcome
Change of muscle strength of the lower extremities
Time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups
Bilateral hip flexors, knee extensors, ankle dorsiflexors and ankle plantarflexors
Change of 30 seconds sit to stand
Time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups
30 seconds sit to stand
Change of timed-up-and-go test
Time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups
Timed-up-and-go test
4 secondary outcomes
Change of one-repetition maximum
Time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups
Change of muscle mass
Time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups
Change of hand grip
Time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups
Change of physical activity level
Time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction resistance training and Resistance training in people with Frailty, 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 11 Jan 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of muscle strength of the lower extremities (time frame: Before training, 3 and 6 weeks after training, and one and two months follow-ups). The study lists 3 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 11 Jan 2022.