BFR Walking for Insulin and Aerobic Improvement in Type 2 Diabetes

NCT06290947 | Completed DMC FDA Device

• 2 other identifiers: BFR-AE-DT2-2023-01IRB 2022/C/20/N
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; Blood-Flow Restriction Training (BFR); Insulin Sensitivity; Aerobic Capacity; Diabetes Management; Low-Intensity Exercise

Outcome Measures

Primary Outcomes (2)

• Improvement in Insulin Sensitivity

  This measure assesses the change in insulin sensitivity determined by cumulative sugar measure.

  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.

  8 weeks

Secondary Outcomes (1)

• Change in Body Mass Index (BMI)

  8 weeks

Study Arms (2)

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.

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.

Other: Standard Walking Training Program

Interventions

BFR Cuffs for Intervention Group DEVICE

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.

Also known as: H+ Cuff 2.0 CURVED BFR Cuffs

Blood-Flow Restriction Walk Training (BFRw)

Standard Walking Training Program OTHER

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.

Blood-Flow Restriction Walk Training (BFRw); Control Group Walk Training

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arab American University (Palestine): lead

Study Sites (1)

Arab American University - Palestine

Jenin, P.O Box 24, Palestinian Territories

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Samer AbuEid, PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 4, 2024
• Study Start: March 6, 2022
• Primary Completion: December 20, 2023
• Study Completion: January 8, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)