Older PatientsNCT06906523
Blood Flow Restriction in Older Adults
A study testing Blood flow restriction training in people with Older Patients, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Introduction. From the age of 80 onwards, more than 50% of people suffer from sarcopenia. The loss of muscle strength leads to a loss of muscle power, impairing functionality and preventing the correct performance of activities of daily living. Objective. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Patients
- What is being tested?
- Blood flow restriction training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- 12 Mar 2025to 15 Apr 2025
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Older adults aged 65 to 80 years
- Independent for standing and walking with the help of assistive devices such as cane and walker
- Both genders
- Normotensive or hypertensive with controlled BP (systolic blood pressure <140 mmHg)
- Sign the informed consent form.
Who cannot join
- People dependent for the performance of activities of daily living.
- People with cognitive impairments that limit the performance of the intervention or assessments.
- Persons undergoing total hip or knee arthroplasty
- Persons receiving physiotherapy treatment at the time of the study
- History of deep vein thrombosis (DVT) or pulmonary embolism
- History of myocardial infarction or stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Flow Restriction in Older Adults. A Randomised Single-blind Clinical Trial
Introduction. From the age of 80 onwards, more than 50% of people suffer from sarcopenia. The loss of muscle strength leads to a loss of muscle power, impairing functionality and preventing the correct performance of activities of daily living.
Objective. To analyse the efficacy of blood flow restriction in older adult patients by evaluating changes in the variables muscle power and strength, physical condition and functionality of the lower limbs.
Material and method. Randomised single-blind clinical study. Thirty-six older adults will be recruited and randomised to the experimental and control groups. The intervention will have a duration of 4 weeks, with 2 weekly sessions. The intervention will consist of an intervention by performing 3 quadriceps strength exercises, with a 40% restriction. The primary variable of the study will be muscle power (Sit To Stand 5 times) and the secondary variables will be muscle strength (dynamometry), physical condition (Timed Up and Go) and functionality and autonomy (Barthel index)
- Conditions
- Older Patients
- Being tested
- Blood flow restriction training
- Keywords
- Blood flow restriction, Older adults, Muscle power, Muscle strength, Functionality, Physical fitness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction trainingOther
The intensity of the work will be set at around 40% of the maximum intensity that can be executed in a single repetition (1RM). To reach the established intensity, weights, weighted ankle supports and rubber bands of different resistances will be used. Three sets of 8-10 repetitions will be performed with breaks of 1-2 seconds between repetitions and 2-3 minutes between sets. The intensity of the work will be established by applying the rate of perceived exertion. A blood flow restriction device will be used (Akrafit, Valencia, Spain model).
| Study group | Role | What they receive |
|---|---|---|
| Blood flow restriction | Experimental | An exercise protocol will be applied to work on lower limb strength in extension, with the application of BFR, with two 30-minute sessions per week for four weeks. The exercise protocol, based on previous studies in older adults, will consist of three exercises: climbing on a step, knee extension from a seated position and sitting down and getting up from a chair. Receives: Other: Blood flow restriction training |
| No intervention | No intervention | Patients included in the control group will not receive any intervention, maintaining their activities of daily living in the same way as before the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline muscle power after treatment and at four weeks
Muscle power will be assessed with the Sit To Stand 5 times. This tool consists of getting up and sitting down from a chair five times. This instrument has shown high reliability (CCI= 0.95). The unit of measurement is time in seconds, where the shorter the time the greater the muscle power
Measured: Screening visit, within the first seven days after treatment and four weeks follow-up visit
Secondary outcomes (3)
Change from baseline muscle strength after treatment and at four weeks
Muscle strength shall be measured with a pressure dynamometer (Lafayette Manual Muscle Tester 01165). For the measurement of quadriceps muscle strength, the patient shall be placed in a seated position with 90° hip flexion and 75° knee flexion. The dynamometer shall be placed perpendicular to the leg to be assessed, just above the lateral malleolus, maintaining 75° of knee flexion. This assessment has shown good intra-observer reliability (ICC>0.70). This device measures in Newton the force performed by the patient in the requested muscle action. The higher the value, the greater the muscle strength
Measured: Screening visit, within the first seven days after treatment and four weeks follow-up visit
Change from baseline physical condition after treatment and at four weeks
Physical condition will be measured with the Timed Up and Go (TUG). This tool consists of the participant getting up from a chair, walking three metres around an obstacle, walking back to the chair and sitting down again in a timed manner. This instrument has shown high reliability (ICC=0.80-0.99). The unit of measurement is time in seconds, where the shorter the time the greater the physical condition
Measured: Screening visit, within the first seven days after treatment and four weeks follow-up visit
Change from baseline functionality after treatment and at four weeks
Functionality and autonomy will be measured with the Barthel Index. This tool consists of a scale assessing ten items: eating, transferring between chair and bed, personal grooming, toilet use, bathing/showering, transferring, going up and down stairs, dressing and undressing, stool control and urine control. Each item is scored 0 (dependent), 5 (performs with assistance) or 10 (independent) according to the degree to which he/she is able to perform it. This instrument has shown high reliability (ICC= 0.96). The score range is from 0 (total dependence) to 100 (independence).
Measured: Screening visit, within the first seven days after treatment and four weeks follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start12 Mar 2025
- Primary completion13 Apr 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older PatientsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubén Cuesta-Barriuso, PhD, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906523
- Sponsor's protocol ID
- Old-Rest
- Status last verified
- Feb 2025
- First submitted
- 11 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction in Older Adults. A Randomised Single-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06906523
- Acronym / sponsor ID
- Old-Rest
- Conditions
- Older Patients
- Keywords
- Blood flow restriction, Older adults, Muscle power, Muscle strength, Functionality, Physical fitness
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 13 Apr 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 2 Apr 2025 (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.
Introduction. From the age of 80 onwards, more than 50% of people suffer from sarcopenia. The loss of muscle strength leads to a loss of muscle power, impairing functionality and preventing the correct performance of activities of daily living.
Objective. To analyse the efficacy of blood flow restriction in older adult patients by evaluating changes in the variables muscle power and strength, physical condition and functionality of the lower limbs.
Material and method. Randomised single-blind clinical study. Thirty-six older adults will be recruited and randomised to the experimental and control groups. The intervention will have a duration of 4 weeks, with 2 weekly sessions. The intervention will consist of an intervention by performing 3 quadriceps strength exercises, with a 40% restriction. The primary variable of the study will be muscle power (Sit To Stand 5 times) and the secondary variables will be muscle strength (dynamometry), physical condition (Timed Up and Go) and functionality and autonomy (Barthel index)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction | Experimental | Other: Blood flow restriction trainingAn exercise protocol will be applied to work on lower limb strength in extension, with the application of BFR, with two 30-minute sessions per week for four weeks. The exercise protocol, based on previous studies in older adults, will consist of three exercises: climbing on a step, knee extension from a seated position and sitting down and getting up from a chair. |
| No intervention | No intervention | –Patients included in the control group will not receive any intervention, maintaining their activities of daily living in the same way as before the study. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Older adults aged 65 to 80 years
- Independent for standing and walking with the help of assistive devices such as cane and walker
- Both genders
- Normotensive or hypertensive with controlled BP (systolic blood pressure <140 mmHg)
- Sign the informed consent form.
Key exclusion criteria (6 listed)
- People dependent for the performance of activities of daily living.
- People with cognitive impairments that limit the performance of the intervention or assessments.
- Persons undergoing total hip or knee arthroplasty
- Persons receiving physiotherapy treatment at the time of the study
- History of deep vein thrombosis (DVT) or pulmonary embolism
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 trainingThe intensity of the work will be set at around 40% of the maximum intensity that can be executed in a single repetition (1RM). To reach the established intensity, weights, weighted ankle supports and rubber bands of different resistances will be used. Three sets of 8-10 repetitions will be performed with breaks of 1-2 seconds between repetitions and 2-3 minutes between sets. The intensity of the work will be established by applying the rate of perceived exertion. A blood flow restriction device will be used (Akrafit, Valencia, Spain model). | Other | Blood flow restriction |
Primary outcome
Change from baseline muscle power after treatment and at four weeks
Time frame: Screening visit, within the first seven days after treatment and four weeks follow-up visit
Muscle power will be assessed with the Sit To Stand 5 times. This tool consists of getting up and sitting down from a chair five times. This instrument has shown high reliability (CCI= 0.95). The unit of measurement is time in seconds, where the shorter the time the greater the muscle power
3 secondary outcomes
Change from baseline muscle strength after treatment and at four weeks
Time frame: Screening visit, within the first seven days after treatment and four weeks follow-up visit
Change from baseline physical condition after treatment and at four weeks
Time frame: Screening visit, within the first seven days after treatment and four weeks follow-up visit
Change from baseline functionality after treatment and at four weeks
Time frame: Screening visit, within the first seven days after treatment and four weeks follow-up visit
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 4 Apr 2025.
- 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 training in people with Older Patients, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 4 Apr 2025. 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 Spain. 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?
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 from baseline muscle power after treatment and at four weeks (time frame: Screening visit, within the first seven days after treatment and four weeks follow-up visit). 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 4 Apr 2025.