Type 2 Diabetes MellitusBRAIDNCT06290947
BFR Walking for Insulin and Aerobic Improvement in Type 2 Diabetes
A study testing BFR Cuffs for Intervention Group and Standard Walking Training Program in people with Type 2 Diabetes Mellitus, run by Arab American University (Palestine) at 1 site in Palestinian Territories.
Trial summary
This clinical trial examines the impact of Blood-Flow Restriction Walk Training (BFRw) on insulin sensitivity and aerobic capacity in individuals with Type 2 Diabetes (T2D). The primary objectives of the study are to determine: If Blood-Flow Restriction Walk Training (BFRw) can improve insulin sensitivity in… Read more about this study
- Who is it for?
- Ages 40 to 65 years, men only
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- BFR Cuffs for Intervention Group and Standard Walking Training Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 6 Mar 2022to 8 Jan 2024
- 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 40 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male individuals of Palestinian descent
- Aged between 40 to 65 years
- Diagnosed with Type 2 Diabetes for a duration of 2 to 10 years, with ongoing medical supervision
- Capable of understanding and following the study's instructions, programs, and protocols
Who cannot join
- Females, due to hormonal and metabolic differences.
- Individuals outside the 40-65 age range to minimize age-related variations in Diabetes Mellitus.
- Patients with conditions or comorbidities that impair walking or elevate the risk associated with Blood-Flow Restriction Training (BFRT).
- An Ankle Brachial Pressure Index (ABI) greater than 0.9, as values outside the normal range (0.9 to 1.4) may indicate Peripheral Arterial Disease (PAD) or Cardiovascular Disease (CVD), affecting eligibility for participation.
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Arab American University - Palestine
Jenin, P.O Box 24
About this study
Official title: Evaluating the Impact of Blood-Flow Restriction Walk Training on Insulin Sensitivity and Aerobic Capacity in Individuals With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
This clinical trial examines the impact of Blood-Flow Restriction Walk Training (BFRw) on insulin sensitivity and aerobic capacity in individuals with Type 2 Diabetes (T2D).
The primary objectives of the study are to determine: If Blood-Flow Restriction Walk Training (BFRw) can improve insulin sensitivity in individuals with Type 2 Diabetes (T2D).
Read more
Whether Blood-Flow Restriction Walk Training (BFRw) enhances aerobic capacity in individuals with Type 2 Diabetes (T2D).
Participants in the study are divided into two groups. One group undergoes Blood-Flow Restriction Walk Training (BFRw), and the other serves as a control. Both groups attend three treadmill walking sessions weekly for eight weeks. The BFRw group has a restriction cuff placed around both thighs during their sessions, while the control group participates in the walking sessions without any blood flow restriction.
Hemoglobin A1c (HbA1c) levels and maximal oxygen consumption (VO2 max) are monitored as indicators of insulin sensitivity and aerobic capacity, respectively.
Read the detailed description
In this clinical trial, the efficacy of Blood-Flow Restriction Walk Training (BFRw) as a therapeutic modality to enhance insulin sensitivity and aerobic capacity is meticulously explored among individuals diagnosed with Type 2 Diabetes. This innovative approach combines the simplicity of low-intensity walking exercises with the physiological benefits of blood-flow restriction applied to the lower extremities, proposing that such a combination can induce muscle adaptations typically associated with high-intensity resistance training.
The study is centered around a rigorously structured protocol, in which participants assigned to the intervention arm undergo supervised BFRw sessions. These sessions are carefully calibrated to ensure a balance between safety and effectiveness, with a focus on gradually increasing the intensity and duration of the exercise to accommodate the varying fitness levels of participants and to mitigate any potential risks associated with blood-flow restriction techniques.
The research primarily investigates the hypothesis that BFRw can lead to significant improvements in metabolic health markers and physical performance metrics without the physical strain associated with traditional high-intensity exercise regimes. By examining the incremental adaptation of skeletal muscle under conditions of reduced oxygen supply, the study aims to uncover the mechanisms through which BFRw supports enhancements in glucose metabolism and cardiovascular fitness.
Furthermore, the study seeks to identify the optimal parameters for blood-flow restriction that maximize therapeutic benefits while minimizing discomfort and potential complications. This involves comprehensive assessments of insulin sensitivity (via glucose tolerance tests and insulin assays) and aerobic capacity (measured through graded exercise testing to determine VO2 max).
This investigation is designed to provide valuable insights into the feasibility, safety, and efficacy of incorporating Blood-Flow Restriction Walk Training into the treatment regimen for Type 2 Diabetes. By redefining exercise recommendations for individuals with limited tolerance for traditional high-intensity workouts, the research could significantly impact future guidelines and practices for managing this prevalent metabolic disorder.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- BFR Cuffs for Intervention Group, Standard Walking Training Program
- Keywords
- Type 2 Diabetes Mellitus, Blood-Flow Restriction Training (BFR), Insulin Sensitivity, Aerobic Capacity, Diabetes Management, Low-Intensity Exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFR Cuffs for Intervention GroupDevice
Also called H+ Cuff 2.0 CURVED BFR Cuffs
The intervention consists of supervised treadmill sessions incorporating specialized BFR cuffs, branded as "H+ Curve," tailored for Blood-Flow Restriction Walk Training (BFRw). These cuffs are strategically positioned on the upper portion of the lower limbs to induce muscle adaptations and
improve metabolic health outcomes. The innovative protocol is designed to probe the potential benefits of BFRw in ameliorating insulin sensitivity and enhancing aerobic capacity, thus presenting a pioneering exercise approach for individuals with Type 2 Diabetes.
Standard Walking Training ProgramOther
The control group will engage in a standard walking training regimen, consisting of supervised treadmill sessions without the application of BFR cuffs. This protocol serves to uphold the scientific rigor of the study by offering a comparison group for the BFRw intervention.
Purpose:
To evaluate the impact of a typical exercise routine on insulin sensitivity and aerobic capacity, thereby establishing a control benchmark to contrast with the effects of the BFRw intervention.
| Study group | Role | What they receive |
|---|---|---|
| Blood-Flow Restriction Walk Training (BFRw) | Experimental | Participants in this group will engage in a Blood-Flow Restriction Walk Training (BFRw) program designed to evaluate the efficacy of BFRw in enhancing insulin sensitivity and aerobic capacity.
Activities:
Participants will attend three weekly supervised walking sessions for eight weeks, each integrating specialized BFR cuffs calibrated to a precise pressure to restrict blood flow during exercise partially.
Purpose:
This arm is crucial for testing the study's primary hypothesis by measuring the intervention's effects against a control group. Receives: Device: BFR Cuffs for Intervention Group; Other: Standard Walking Training Program |
| Control Group Walk Training | Active comparator | Participants in this group will engage in a conventional walking training program without applying BFR cuffs.
Activities:
Participants will attend three weekly supervised walking sessions for eight weeks without using BFR cuffs.
Purpose:
This group will serve as a benchmark to ascertain the effectiveness of the intervention, providing a baseline for the comparative analysis of the results obtained from the intervention group. Receives: Other: Standard Walking Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Insulin Sensitivity
This measure assesses the change in insulin sensitivity determined by cumulative sugar measure.
Measured: 8 weeks
Improvement in Aerobic Capacity
This outcome measure will evaluate the change in aerobic capacity as indicated by VO2 max (maximal oxygen consumption) levels. This assessment will determine the effectiveness of Blood-Flow Restriction Walk Training in enhancing aerobic efficiency in participants.
Measured: 8 weeks
Secondary outcomes (1)
Change in Body Mass Index (BMI)
This outcome will track the change in participants' Body Mass Index (BMI) to assess any impact of Blood-Flow Restriction Walk Training on body composition. BMI will be calculated using measured weight and height at baseline and at the end of the study period.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start6 Mar 2022
- Primary completion20 Dec 2023
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study employs a randomized controlled trial model with a parallel assignment to evaluate the efficacy of Blood-Flow Restriction Walk Training compared to a control condition. Participants are randomly allocated into two groups: one receiving the intervention (BFR walk training) and the other serving as a control (usual walk training). This design allows for the direct comparison of outcomes between the intervention and control groups over the study period.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arab American University (Palestine)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samer AbuEid, Arab American University (Palestine)
- Investigators
- Samer AbuEid, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290947
- Sponsor's protocol ID
- BFR-AE-DT2-2023-01
- Other IDs
- IRB 2022/C/20/N
- Acronym
- BRAID
- Status last verified
- Mar 2024
- First submitted
- 21 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Blood-Flow Restriction Walk Training on Insulin Sensitivity and Aerobic Capacity in Individuals With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06290947
- Acronym / sponsor ID
- BRAID / BFR-AE-DT2-2023-01
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Blood-Flow Restriction Training (BFR), Insulin Sensitivity, Aerobic Capacity, Diabetes Management, Low-Intensity Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Arab American University (Palestine)University, hospital or other
- Study start
- 6 Mar 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 4 Mar 2024 (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 clinical trial examines the impact of Blood-Flow Restriction Walk Training (BFRw) on insulin sensitivity and aerobic capacity in individuals with Type 2 Diabetes (T2D).
The primary objectives of the study are to determine: If Blood-Flow Restriction Walk Training (BFRw) can improve insulin sensitivity in individuals with Type 2 Diabetes (T2D).
Whether Blood-Flow Restriction Walk Training (BFRw) enhances aerobic capacity in individuals with Type 2 Diabetes (T2D).
Participants in the study are divided into two groups. One group undergoes Blood-Flow Restriction Walk Training (BFRw), and the other serves as a control. Both groups attend three treadmill walking sessions weekly for eight weeks. The BFRw group has a restriction cuff placed around both thighs during their sessions, while the control group participates in the walking sessions without any blood flow restriction.
Hemoglobin A1c (HbA1c) levels and maximal oxygen consumption (VO2 max) are monitored as indicators of insulin sensitivity and aerobic capacity, respectively.
Detailed description
In this clinical trial, the efficacy of Blood-Flow Restriction Walk Training (BFRw) as a therapeutic modality to enhance insulin sensitivity and aerobic capacity is meticulously explored among individuals diagnosed with Type 2 Diabetes. This innovative approach combines the simplicity of low-intensity walking exercises with the physiological benefits of blood-flow restriction applied to the lower extremities, proposing that such a combination can induce muscle adaptations typically associated with high-intensity resistance training.
The study is centered around a rigorously structured protocol, in which participants assigned to the intervention arm undergo supervised BFRw sessions. These sessions are carefully calibrated to ensure a balance between safety and effectiveness, with a focus on gradually increasing the intensity and duration of the exercise to accommodate the varying fitness levels of participants and to mitigate any potential risks associated with blood-flow restriction techniques.
The research primarily investigates the hypothesis that BFRw can lead to significant improvements in metabolic health markers and physical performance metrics without the physical strain associated with traditional high-intensity exercise regimes. By examining the incremental adaptation of skeletal muscle under conditions of reduced oxygen supply, the study aims to uncover the mechanisms through which BFRw supports enhancements in glucose metabolism and cardiovascular fitness.
Furthermore, the study seeks to identify the optimal parameters for blood-flow restriction that maximize therapeutic benefits while minimizing discomfort and potential complications. This involves comprehensive assessments of insulin sensitivity (via glucose tolerance tests and insulin assays) and aerobic capacity (measured through graded exercise testing to determine VO2 max).
This investigation is designed to provide valuable insights into the feasibility, safety, and efficacy of incorporating Blood-Flow Restriction Walk Training into the treatment regimen for Type 2 Diabetes. By redefining exercise recommendations for individuals with limited tolerance for traditional high-intensity workouts, the research could significantly impact future guidelines and practices for managing this prevalent metabolic disorder.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study employs a randomized controlled trial model with a parallel assignment to evaluate the efficacy of Blood-Flow Restriction Walk Training compared to a control condition. Participants are randomly allocated into two groups: one receiving the intervention (BFR walk training) and the other serving as a control (usual walk training). This design allows for the direct comparison of outcomes between the intervention and control groups over the study period.
| Arm | Type | Receives |
|---|---|---|
| Blood-Flow Restriction Walk Training (BFRw) | Experimental | Device: BFR Cuffs for Intervention Group, Other: Standard Walking Training ProgramParticipants in this group will engage in a Blood-Flow Restriction Walk Training (BFRw) program designed to evaluate the efficacy of BFRw in enhancing insulin sensitivity and aerobic capacity. Activities: Participants will attend three weekly supervised walking sessions for eight weeks, each integrating specialized BFR cuffs calibrated to a precise pressure to restrict blood flow during exercise partially. Purpose: This arm is crucial for testing the study's primary hypothesis by measuring the intervention's effects against a control group. |
| Control Group Walk Training | Active comparator | Other: Standard Walking Training ProgramParticipants in this group will engage in a conventional walking training program without applying BFR cuffs. Activities: Participants will attend three weekly supervised walking sessions for eight weeks without using BFR cuffs. Purpose: This group will serve as a benchmark to ascertain the effectiveness of the intervention, providing a baseline for the comparative analysis of the results obtained from the intervention group. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male individuals of Palestinian descent
- Aged between 40 to 65 years
- Diagnosed with Type 2 Diabetes for a duration of 2 to 10 years, with ongoing medical supervision
- Capable of understanding and following the study's instructions, programs, and protocols
Key exclusion criteria (4 listed)
- Females, due to hormonal and metabolic differences.
- Individuals outside the 40-65 age range to minimize age-related variations in Diabetes Mellitus.
- Patients with conditions or comorbidities that impair walking or elevate the risk associated with Blood-Flow Restriction Training (BFRT).
- An Ankle Brachial Pressure Index (ABI) greater than 0.9, as values outside the normal range (0.9 to 1.4) may indicate Peripheral Arterial Disease (PAD) or Cardiovascular Disease (CVD), affecting eligibility for participation.
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 |
|---|---|---|
| BFR Cuffs for Intervention GroupAlso: H+ Cuff 2.0 CURVED BFR CuffsThe intervention consists of supervised treadmill sessions incorporating specialized BFR cuffs, branded as "H+ Curve," tailored for Blood-Flow Restriction Walk Training (BFRw). These cuffs are strategically positioned on the upper portion of the lower limbs to induce muscle adaptations and improve metabolic health outcomes. The innovative protocol is designed to probe the potential benefits of BFRw in ameliorating insulin sensitivity and enhancing aerobic capacity, thus presenting a pioneering exercise approach for individuals with Type 2 Diabetes. | Device | Blood-Flow Restriction Walk Training (BFRw) |
| Standard Walking Training ProgramThe control group will engage in a standard walking training regimen, consisting of supervised treadmill sessions without the application of BFR cuffs. This protocol serves to uphold the scientific rigor of the study by offering a comparison group for the BFRw intervention. Purpose: To evaluate the impact of a typical exercise routine on insulin sensitivity and aerobic capacity, thereby establishing a control benchmark to contrast with the effects of the BFRw intervention. | Other | Blood-Flow Restriction Walk Training (BFRw), Control Group Walk Training |
Primary outcome
Improvement in Insulin Sensitivity
Time frame: 8 weeks
This measure assesses the change in insulin sensitivity determined by cumulative sugar measure.
Improvement in Aerobic Capacity
Time frame: 8 weeks
This outcome measure will evaluate the change in aerobic capacity as indicated by VO2 max (maximal oxygen consumption) levels. This assessment will determine the effectiveness of Blood-Flow Restriction Walk Training in enhancing aerobic efficiency in participants.
1 secondary outcome
Change in Body Mass Index (BMI)
Time frame: 8 weeks
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 4 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Samer AbuEid, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFR Cuffs for Intervention Group and Standard Walking Training Program in people with Type 2 Diabetes Mellitus, run by Arab American University (Palestine) at 1 site in Palestinian Territories.
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 4 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 4 Mar 2024. 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 Palestinian Territories. 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?
Improvement in Insulin Sensitivity (time frame: 8 weeks). The study lists 2 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 4 Mar 2024.