FrailtyNCT05209685
Blood Flow Restriction on Functional Mobility in Pre-frail Older Adults
A study testing Resistance exercise on the lower extremities and Resistance exercise on the lower extremities with blood flow restriction in people with Frailty, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
This study investigates the effect of blood flow restriction with resistance exercise on functional mobility in pre-frail older adults. It is hypothesized that receiving resistance exercise with blood flow restriction will exhibit better improvement on functional mobility than only receiving resistance exercise in… Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Frailty
- What is being tested?
- Resistance exercise on the lower extremities and Resistance exercise on the lower extremities with blood flow restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Aug 2020to 31 Dec 2022
- 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 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged over 65 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 Exercise on Functional Mobility in Pre-Frail Older Adults
This study investigates the effect of blood flow restriction with resistance exercise on functional mobility in pre-frail older adults. It is hypothesized that receiving resistance exercise with blood flow restriction will exhibit better improvement on functional mobility than only receiving resistance exercise in pre-frail older adults.
Read the detailed description
Participants aged over 65 years old with less than two items positive of Fried frailty phenotype assessment result will be recruited. The participants will be randomly assigned to two training groups, blood flow restriction resistance exercise and traditional resistance exercise. Both groups will receive the training 30 minutes/session, two sessions/week for six weeks. Muscle strength of the lower extremities and functional mobility tests will be used to assess outcomes at pre-training, 3-week after training, post-training, and one-month and two-month follow-up.
- Conditions
- Frailty
- Being tested
- Resistance exercise on the lower extremities, Resistance exercise on the lower extremities with blood flow restriction
- Keywords
- pre-frail, blood flow restriction, functional mobility
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exercise on the lower extremitiesOther
Resistance exercise mainly on the lower extremities will be executed by carrying weight according to each participant's tolerance while performing certain movements, such as side step-up, sit-to-stand, and tip-toe-standing.
Resistance exercise on the lower extremities with blood flow restrictionOther
Blood flow restriction on the thigh of the dominant leg will be used in combination with resistance exercise.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Resistance exercise with blood flow restriction Receives: Other: Resistance exercise on the lower extremities with blood flow restriction |
| Control | Active comparator | Traditional resistance exercise Receives: Other: Resistance exercise on the lower extremities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Timed-Up and Go (TUG) test
Timed-Up and Go test
Measured: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
Change of 30 seconds sit to stand
30 seconds sit to stand test
Measured: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
Change of muscle strength of the lower extremities
Muscle strength of bilateral hip flexors, knee extensors, ankle dorsiflexors and plantarflexors
Measured: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
Secondary outcomes (3)
Change of one-repetition maximum
One-repetiton maximum of side step-ups
Measured: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
Change of muscle mass
Muscle mass of the upper and lower extremities and trunk
Measured: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
Change of hand grip strength
Bilateral grip strength
Measured: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start17 Aug 2020
- Primary completion31 Oct 2022
- Study completion31 Dec 2022
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
- 54 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
- NCT05209685
- Sponsor's protocol ID
- A-BR-110-075
- Status last verified
- Nov 2023
- First submitted
- 10 Jan 2022
- Last updated
- 27 Nov 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 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Blood Flow Restriction Resistance Exercise on Functional Mobility in Pre-Frail Older Adults
- ClinicalTrials.gov ID
- NCT05209685
- Acronym / sponsor ID
- A-BR-110-075
- Conditions
- Frailty
- Keywords
- pre-frail, blood flow restriction, functional mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Jan 2022 (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 study investigates the effect of blood flow restriction with resistance exercise on functional mobility in pre-frail older adults. It is hypothesized that receiving resistance exercise with blood flow restriction will exhibit better improvement on functional mobility than only receiving resistance exercise in pre-frail older adults.
Detailed description
Participants aged over 65 years old with less than two items positive of Fried frailty phenotype assessment result will be recruited. The participants will be randomly assigned to two training groups, blood flow restriction resistance exercise and traditional resistance exercise. Both groups will receive the training 30 minutes/session, two sessions/week for six weeks. Muscle strength of the lower extremities and functional mobility tests will be used to assess outcomes at pre-training, 3-week after training, post-training, and one-month and two-month 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 | Experimental | Other: Resistance exercise on the lower extremities with blood flow restrictionResistance exercise with blood flow restriction |
| Control | Active comparator | Other: Resistance exercise on the lower extremitiesTraditional resistance exercise |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged over 65 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 |
|---|---|---|
| Resistance exercise on the lower extremitiesResistance exercise mainly on the lower extremities will be executed by carrying weight according to each participant's tolerance while performing certain movements, such as side step-up, sit-to-stand, and tip-toe-standing. | Other | Control |
| Resistance exercise on the lower extremities with blood flow restrictionBlood flow restriction on the thigh of the dominant leg will be used in combination with resistance exercise. | Other | Experimental |
Primary outcome
Change of Timed-Up and Go (TUG) test
Time frame: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
Timed-Up and Go test
Change of 30 seconds sit to stand
Time frame: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
30 seconds sit to stand test
Change of muscle strength of the lower extremities
Time frame: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
Muscle strength of bilateral hip flexors, knee extensors, ankle dorsiflexors and plantarflexors
3 secondary outcomes
Change of one-repetition maximum
Time frame: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
Change of muscle mass
Time frame: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
Change of hand grip strength
Time frame: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention
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 27 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Frailty
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
Mobility Impairment, Frailty
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
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 Resistance exercise on the lower extremities and Resistance exercise on the lower extremities with blood flow restriction 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 27 Nov 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?
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 Timed-Up and Go (TUG) test (time frame: Before intervention, 3 and 6 weeks after intervention, and one- and two-month follow ups after intervention). 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 27 Nov 2023.