Stroke, IschemicNCT05281679
The Effects of Blood Flow Restriction With Low-intensity Resistance Training Versus Traditional Resistance Exercise on Lower Limb Strength, Walking Capacity, and Balance in Patients With Ischemic Stroke: (BFR-Stroke RESILIENCE Trial)
A study testing Low-intensity resistance exercise with blood flow restriction group (L-BFR) and High-intensity resistance exercise without blood flow restriction group (H-BFR). in people with Stroke, Ischemic and Cerebrovascular Accident, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Stroke is the leading neurological disease in the world that causes long-term disability. The most common cause of disability after stroke is motor impairment resulting from brain damage which ultimately causes mobility and functional limitation. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Ischemic, Cerebrovascular Accident
- What is being tested?
- Low-intensity resistance exercise with blood flow restriction group (L-BFR) and High-intensity resistance exercise without blood flow restriction group (H-BFR).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2022to 15 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All the participants will be evaluated to be in stable Cardio-vascular condition i,e ACSM Class B.
- 18 to 90 years of age.
- More than 1 month of stroke onset.
- First ever unilateral ischemic stroke.
- Being able to walk 10 m independently with or without an assistive device.
- Being an independent ambulator (Functional Ambulation Scale>3).
- Muscle tension of the modified Ashworth scale was lower than grade.
Who cannot join
- People with a history of mental illness.
- People with obvious cognitive impairments.
- Combination with peripheral neuropathy.
- Having resting blood pressure above 160/100 mmHg even after taking medications.
- Hemorrhagic stroke
- Cardiovascular comorbidity (aortic stenosis, depression of ST-segment, heart failure, arrhythmias, unstable angina, hypertrophic cardiomyopathy).
Show all 10Show fewer
- Transient ischemic attack.
- By-pass surgery in the recent three months
- Any 0ther musculoskeletal problems that prevented the participants from doing resistance training
- People who have taken antipyretics, analgesics, dopamine, and other drugs that affect autonomic nerve function within 2 weeks.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Göztepe Prof. Dr. Süleyman Yalçın City Hospital
Istanbul, 34160
About this study
Stroke is the leading neurological disease in the world that causes long-term disability. The most common cause of disability after stroke is motor impairment resulting from brain damage which ultimately causes mobility and functional limitation. Worldwide, the incidence of stroke has been increased by 30% in the last decade. In Europe, more than one million cases have been reported each year and six million stroke survivors are known to be alive till now. The annual estimated cause of stroke treatment in Europe is twenty-seven billion Euros. By 2030, it is estimated that the cost of stroke treatment will be triple the current amount and can reach up to 184 billion dollars. Therefore, it is necessary to develop an economical rehabilitation program that prevents or reduces long-term disability after stroke.
Read the detailed description
Blood flow restriction combined with resistance training may be an economic and time-efficient alternative to High-Intensity Training to manage the risk factors of stroke and can also be useful in reducing stroke-related impairment effectively. During BFRT, the blood flow of the exercising muscle is restricted by placing the inflated tourniquets at the most proximal part of the legs or arms. By restricting the blood flow to the limbs, the desired muscle group will work in an ischemic environment and can trigger a significant increase in muscle mass, power, and strength by recruiting the fast-twitch muscle fibers. BFRT could be a promising type of exercise for high-risk groups of patients such as Cardiovascular disease, stroke, etc, and the hypertrophy responses induced by is comparable to that produced by high-intensity training. It was found that BFRT and high-intensity training produced similar effects on both systolic, diastolic blood pressure, and heart rate (HR) in young individuals and older adults. Previous evidence from neurological studies showed that resistance combined with blood flow restriction can improve muscle strength, balance, walking capacity, and cognitive function in Multiple Sclerosis and spinal cord injury patients. Recent study showed that BFR combined with resistance training has improved brain-derived neurotrophic factor (BDNF) and vascular endothelial growth factor (VEGF) and rate of perceived exertion in ischemic stroke patients. Kaatsu training society also reported a few cases in which BFRT has produced a positive effect on the recovery of stroke patients, but the evidence is insufficient to support this assertion.
- Conditions
- Stroke, Ischemic, Cerebrovascular Accident
- Being tested
- Low-intensity resistance exercise with blood flow restriction group (L-BFR), High-intensity resistance exercise without blood flow restriction group (H-BFR).
- Keywords
- Blood flow restriction, Resistance exercise, Mobility, Walking capacity
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity resistance exercise with blood flow restriction group (L-BFR)Other
The blood flow restriction training group will perform 3 sets of Sandbag (SB) resistance exercises, targeting the large muscles of the legs, at 40% of 1-RM. The SB protocol consists of 3 sets of 4 SB exercises. Each set consists of 10 repetitions of 1-RM with a 1-min recovery interval between sets and 3-min between exercises. Blood flow to the active muscle during training will be restricted by a blood flow restriction band (tourniquet) placed at the proximal end of the lower limbs. When the subjects performed training with BFR, the proximal portions of their lower limbs will be compressed at the pressure of 120-160 mmHg by electronically controlled air pressure belts. The air pressure belt will be inflated before the exercise and will remain inflated during one-minute intervals between the sets and will be deflated during the three-minute interval between the exercise.
High-intensity resistance exercise without blood flow restriction group (H-BFR).Other
The high-intensity restriction training group will perform 3 sets of Sandbag (SB) resistance exercises, targeting the large muscles of the legs, at 80% of 1-RM. The SB protocol consist of 3 sets of 4 SB exercises. Each set consists of 10 repetitions of 1-RM with a 1-min rest interval between sets and 3-min between exercises.
| Study group | Role | What they receive |
|---|---|---|
| Low-intensity resistance exercise with blood flow restriction group (L-BFR). | Experimental | All the participants in the low-intensity resistance exercise with blood flow restriction group (L-BFR) will receive 3 sessions of low-intensity resistance training with blood flow restriction for a total of 5 weeks. Receives: Other: Low-intensity resistance exercise with blood flow restriction group (L-BFR) |
| High-intensity resistance exercise without blood flow restriction group (H-BFR). | Active comparator | All the participants in the high-intensity resistance exercise without blood flow restriction group (H-BFR) will receive 3 sessions of high-intensity resistance training without blood flow restriction for a total of 5 weeks. Receives: Other: High-intensity resistance exercise without blood flow restriction group (H-BFR). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change score of Sit to stand Test
Five time sit to stand test will be used to assess lower extremity muscle strength, balance and risk of fall in stroke patients. The test measure amount of time taken to complete five repetitions of sit to stand task. The test will be performed with standard height chair without an armrest and with straight back (43-45 cm high). He patients will be instructed to stand up and sit down as quickly as possible 5 times, keeping their arms folded across their chest. Timing began when the patient's back left the backrest and stopped once the back touched the backrest for the fifth time.
Measured: Baseline, Post-intervention (Approximately 5 weeks), follow-up (up to 3 Months)
Change score of 10 Meter walk Test
The Comfortable 10-m Walk Test (10 MWT) will be used to determine the speed of comfortable walking. The test will be applied in a 14-m corridor. The patients will be instructed to walk comfortably and allowed to use walking aid. At the 2nd meter, the stopwatch will be started and stopped when the patient reached the 12th meter. Walking time and number of steps will be assessed to calculate gait speed (m/s), stride length (m), and cadence (steps/min). After three trials, the average of the three trials will be recorded as m/s.
Measured: Baseline, Post-intervention (Approximately 5 weeks)
Change score of Timed up and Go Test (TUG)
The Timed Up \& Go test is a functional mobility test used to assess dynamic balance, transfer, and gait. The patient is instructed to stand up from a chair (46 cm high) with support for the arms, walk for a short distance (3 m), turn, go back and sit down as quickly as possible. The stopwatch will be used to measure the time to perform these tasks from start to end. The patients will be allowed to use their walking aids. After three trials, the average of the three trials will be recorded.
Measured: Baseline, Post-intervention (Approximately 5 weeks)
Change score of 6 Minute walk Test
The walking distance will be measured by the 6 Minute walk Test (6MWT), the most commonly used for measuring the physical performance of individuals after stroke. The patients will be asked to walk as far as possible throughout the 30-meter course within 6 minutes by following the standardized instructions provided by the physiotherapist. Participants will be allowed by the physiotherapist to use aiding device if necessary. Physiotherapist will guard the participants during the walk test but will not offer any assistance or support to the participant.
Measured: Baseline, Post-intervention (Approximately 5 weeks)
Change score of Barthel Index
The Barthel Index measures a person's performance in activities of daily living. The Barthel Index consists of 10 items of mobility and self care activities of daily living. This score will be measured on admission and at the end of intervention (at the end of 5th week). The minimum score is 0 and the maximum is 100. A higher score indicates a better outcome.
Measured: Baseline, Post-intervention (Approximately 5 weeks)
Secondary outcomes (3)
Change score of Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale scoring from 0 to 3 for each item. The first seven items relate to anxiety (HADS-A), and the remaining seven items relate to depression (HADS-D). The global scoring ranges from 0 to 42 with a cut-off point of 8/21 for anxiety and 8/21 for depression. The higher the score, the greater anxiety or depression symptoms. HADS will be performed at the beginning and after four weeks of treatment.
Measured: Baseline, Post-intervention (Approximately 5 weeks)
Attendance
Attendance of training sessions measured via Hospital entry sheet.
Measured: Number of sessions attended will be measured during the 5 weeks of intervention protocol.
Adverse Events
Any adverse event or near miss is required to be reported.
Measured: Any adverse event reported during the 5 weeks of intervention protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start20 Mar 2022
- Primary completion15 Aug 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ishtiaq Ahmed, Istanbul University - Cerrahpasa
- Investigators
- Rustem Mustafaoglu, PhD, Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281679
- Sponsor's protocol ID
- E-13022260-199-207631
- Status last verified
- Mar 2022
- First submitted
- 17 Feb 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Freitas EDS, Miller RM, Heishman AD, Aniceto RR, Larson R, Pereira HM, Bemben D, Bemben MG. The perceptual responses of individuals with multiple sclerosis to blood flow restriction versus traditional resistance exercise. Physiol Behav. 2021 Feb 1;229:113219. doi: 10.1016/j.physbeh.2020.113219. Epub 2020 Oct 24.
PubMed 33250152Du X, Chen W, Zhan N, Bian X, Yu W. The effects of low-intensity resistance training with or without blood flow restriction on serum BDNF, VEGF and perception in patients with post-stroke depression. Neuro Endocrinol Lett. 2021 Aug 28;42(4):229-235.
PubMed 34436843Ahmed I, Mustafaoglu R, Erhan B. The effects of low-intensity resistance training with blood flow restriction versus traditional resistance exercise on lower extremity muscle strength and motor functionin ischemic stroke survivors: a randomized controlled trial. Top Stroke Rehabil. 2024 May;31(4):418-429. doi: 10.1080/10749357.2023.2259170. Epub 2023 Sep 19.
PubMed 37724785
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Blood Flow Restriction With Low-intensity Resistance Training Versus Traditional Resistance Exercise on Lower Limb Strength, Walking Capacity, and Balance in Patients With Ischemic Stroke: (BFR-Stroke RESILIENCE Trial)
- ClinicalTrials.gov ID
- NCT05281679
- Acronym / sponsor ID
- E-13022260-199-207631
- Conditions
- Stroke, Ischemic, Cerebrovascular Accident
- Keywords
- Blood flow restriction, Resistance exercise, Mobility, Walking capacity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 16 Mar 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.
Stroke is the leading neurological disease in the world that causes long-term disability. The most common cause of disability after stroke is motor impairment resulting from brain damage which ultimately causes mobility and functional limitation. Worldwide, the incidence of stroke has been increased by 30% in the last decade. In Europe, more than one million cases have been reported each year and six million stroke survivors are known to be alive till now. The annual estimated cause of stroke treatment in Europe is twenty-seven billion Euros. By 2030, it is estimated that the cost of stroke treatment will be triple the current amount and can reach up to 184 billion dollars. Therefore, it is necessary to develop an economical rehabilitation program that prevents or reduces long-term disability after stroke.
Detailed description
Blood flow restriction combined with resistance training may be an economic and time-efficient alternative to High-Intensity Training to manage the risk factors of stroke and can also be useful in reducing stroke-related impairment effectively. During BFRT, the blood flow of the exercising muscle is restricted by placing the inflated tourniquets at the most proximal part of the legs or arms. By restricting the blood flow to the limbs, the desired muscle group will work in an ischemic environment and can trigger a significant increase in muscle mass, power, and strength by recruiting the fast-twitch muscle fibers. BFRT could be a promising type of exercise for high-risk groups of patients such as Cardiovascular disease, stroke, etc, and the hypertrophy responses induced by is comparable to that produced by high-intensity training. It was found that BFRT and high-intensity training produced similar effects on both systolic, diastolic blood pressure, and heart rate (HR) in young individuals and older adults. Previous evidence from neurological studies showed that resistance combined with blood flow restriction can improve muscle strength, balance, walking capacity, and cognitive function in Multiple Sclerosis and spinal cord injury patients. Recent study showed that BFR combined with resistance training has improved brain-derived neurotrophic factor (BDNF) and vascular endothelial growth factor (VEGF) and rate of perceived exertion in ischemic stroke patients. Kaatsu training society also reported a few cases in which BFRT has produced a positive effect on the recovery of stroke patients, but the evidence is insufficient to support this assertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-intensity resistance exercise with blood flow restriction group (L-BFR). | Experimental | Other: Low-intensity resistance exercise with blood flow restriction group (L-BFR)All the participants in the low-intensity resistance exercise with blood flow restriction group (L-BFR) will receive 3 sessions of low-intensity resistance training with blood flow restriction for a total of 5 weeks. |
| High-intensity resistance exercise without blood flow restriction group (H-BFR). | Active comparator | Other: High-intensity resistance exercise without blood flow restriction group (H-BFR).All the participants in the high-intensity resistance exercise without blood flow restriction group (H-BFR) will receive 3 sessions of high-intensity resistance training without blood flow restriction for a total of 5 weeks. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All the participants will be evaluated to be in stable Cardio-vascular condition i,e ACSM Class B.
- 18 to 90 years of age.
- More than 1 month of stroke onset.
- First ever unilateral ischemic stroke.
- Being able to walk 10 m independently with or without an assistive device.
Key exclusion criteria (10 listed)
- People with a history of mental illness.
- People with obvious cognitive impairments.
- Combination with peripheral neuropathy.
- Having resting blood pressure above 160/100 mmHg even after taking medications.
- Hemorrhagic stroke
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 |
|---|---|---|
| Low-intensity resistance exercise with blood flow restriction group (L-BFR)The blood flow restriction training group will perform 3 sets of Sandbag (SB) resistance exercises, targeting the large muscles of the legs, at 40% of 1-RM. The SB protocol consists of 3 sets of 4 SB exercises. Each set consists of 10 repetitions of 1-RM with a 1-min recovery interval between sets and 3-min between exercises. Blood flow to the active muscle during training will be restricted by a blood flow restriction band (tourniquet) placed at the proximal end of the lower limbs. When the subjects performed training with BFR, the proximal portions of their lower limbs will be compressed at the pressure of 120-160 mmHg by electronically controlled air pressure belts. The air pressure belt will be inflated before the exercise and will remain inflated during one-minute intervals between the sets and will be deflated during the three-minute interval between the exercise. | Other | Low-intensity resistance exercise with blood flow restriction group (L-BFR). |
| High-intensity resistance exercise without blood flow restriction group (H-BFR).The high-intensity restriction training group will perform 3 sets of Sandbag (SB) resistance exercises, targeting the large muscles of the legs, at 80% of 1-RM. The SB protocol consist of 3 sets of 4 SB exercises. Each set consists of 10 repetitions of 1-RM with a 1-min rest interval between sets and 3-min between exercises. | Other | High-intensity resistance exercise without blood flow restriction group (H-BFR). |
Primary outcome
Change score of Sit to stand Test
Time frame: Baseline, Post-intervention (Approximately 5 weeks), follow-up (up to 3 Months)
Five time sit to stand test will be used to assess lower extremity muscle strength, balance and risk of fall in stroke patients. The test measure amount of time taken to complete five repetitions of sit to stand task. The test will be performed with standard height chair without an armrest and with straight back (43-45 cm high). He patients will be instructed to stand up and sit down as quickly as possible 5 times, keeping their arms folded across their chest. Timing began when the patient's back left the backrest and stopped once the back touched the backrest for the fifth time.
Change score of 10 Meter walk Test
Time frame: Baseline, Post-intervention (Approximately 5 weeks)
The Comfortable 10-m Walk Test (10 MWT) will be used to determine the speed of comfortable walking. The test will be applied in a 14-m corridor. The patients will be instructed to walk comfortably and allowed to use walking aid. At the 2nd meter, the stopwatch will be started and stopped when the patient reached the 12th meter. Walking time and number of steps will be assessed to calculate gait speed (m/s), stride length (m), and cadence (steps/min). After three trials, the average of the three trials will be recorded as m/s.
Change score of Timed up and Go Test (TUG)
Time frame: Baseline, Post-intervention (Approximately 5 weeks)
The Timed Up \& Go test is a functional mobility test used to assess dynamic balance, transfer, and gait. The patient is instructed to stand up from a chair (46 cm high) with support for the arms, walk for a short distance (3 m), turn, go back and sit down as quickly as possible. The stopwatch will be used to measure the time to perform these tasks from start to end. The patients will be allowed to use their walking aids. After three trials, the average of the three trials will be recorded.
Change score of 6 Minute walk Test
Time frame: Baseline, Post-intervention (Approximately 5 weeks)
The walking distance will be measured by the 6 Minute walk Test (6MWT), the most commonly used for measuring the physical performance of individuals after stroke. The patients will be asked to walk as far as possible throughout the 30-meter course within 6 minutes by following the standardized instructions provided by the physiotherapist. Participants will be allowed by the physiotherapist to use aiding device if necessary. Physiotherapist will guard the participants during the walk test but will not offer any assistance or support to the participant.
Change score of Barthel Index
Time frame: Baseline, Post-intervention (Approximately 5 weeks)
The Barthel Index measures a person's performance in activities of daily living. The Barthel Index consists of 10 items of mobility and self care activities of daily living. This score will be measured on admission and at the end of intervention (at the end of 5th week). The minimum score is 0 and the maximum is 100. A higher score indicates a better outcome.
3 secondary outcomes
Change score of Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline, Post-intervention (Approximately 5 weeks)
Attendance
Time frame: Number of sessions attended will be measured during the 5 weeks of intervention protocol.
Adverse Events
Time frame: Any adverse event reported during the 5 weeks of intervention protocol.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Background: PubMed 33250152Freitas EDS, Miller RM, Heishman AD, Aniceto RR, Larson R, Pereira HM, Bemben D, Bemben MG. The perceptual responses of individuals with multiple sclerosis to blood flow restriction versus traditional resistance exercise. Physiol Behav. 2021 Feb 1;229:113219. doi: 10.1016/j.physbeh.2020.113219. Epub 2020 Oct 24.
- Results publication: PubMed 34436843Du X, Chen W, Zhan N, Bian X, Yu W. The effects of low-intensity resistance training with or without blood flow restriction on serum BDNF, VEGF and perception in patients with post-stroke depression. Neuro Endocrinol Lett. 2021 Aug 28;42(4):229-235.
- Derived from this study: PubMed 37724785Ahmed I, Mustafaoglu R, Erhan B. The effects of low-intensity resistance training with blood flow restriction versus traditional resistance exercise on lower extremity muscle strength and motor functionin ischemic stroke survivors: a randomized controlled trial. Top Stroke Rehabil. 2024 May;31(4):418-429. doi: 10.1080/10749357.2023.2259170. Epub 2023 Sep 19.
- 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.
Rustem Mustafaoglu, PhD study chair
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-intensity resistance exercise with blood flow restriction group (L-BFR) and High-intensity resistance exercise without blood flow restriction group (H-BFR). in people with Stroke, Ischemic and Cerebrovascular Accident, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 7 inclusion and 10 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 22 Mar 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 Turkey (Türkiye). 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?
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 score of Sit to stand Test (time frame: Baseline, Post-intervention (Approximately 5 weeks), follow-up (up to 3 Months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05281679, which also lists 3 linked publications.
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 22 Mar 2022.