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BFR Walking for Insulin and Aerobic Improvement in Type 2 Diabetes

NCT06290947 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-04

No results posted yet for this study

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

Interventions

DEVICE

BFR Cuffs for Intervention Group

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.

OTHER

Standard Walking Training Program

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.

Sponsors & Collaborators

  • Arab American University (Palestine)

    lead OTHER

Principal Investigators

  • Samer AbuEid, PhD

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-06
Primary Completion
2023-12-20
Completion
2024-01-08
FDA Device
Yes

Countries

  • Palestinian Territories

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06290947 on ClinicalTrials.gov