Effect of BFR Training on Glycemic Control, Functional Activity and Quality of Life in Individuals With Pre-diabetes

NCT05411640 | Completed

• 1 other identifier: REC/RCR & AHS/22/1103
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the effects of blood flow restriction training on glycemic control and functional activity in participants with prediabetes. Moreover, This study determine the effects of blood flow restriction training on quality of life in participants with prediabetes

Conditions

PreDiabetes

Keywords

Prediabetic State; Glycemic Control

Outcome Measures

Primary Outcomes (3)

• Fasting Blood Sugar Level

  This measures your blood sugar after an overnight fast (not eating). A fasting blood sugar level of 99 mg/dL or lower is normal, 100 to 125 mg/dL indicates you have prediabetes, and 126 mg/dL or higher indicates you have diabetes.

  16th week

• Hemoglobin A1c (HbA1c) test

  ,A hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin. An HbA1c test may be used to check for diabetes or prediabetes in adults. The Centers for Disease Control (CDC) recommends that adults over the age of 45 get tested to screen for diabetes and prediabetes. HbA1c results are given in percentages. Typical results for this test are Normal value of HbA1c below 5.7%, for prediabetes, HbA1c between 5.7% and 6.4%, for diabetes, HbA1c of 6.5% or higher.

  16th week

• Australian type 2 diabetes risk assessment tool (AUSDRISK)

  The Australian type 2 diabetes risk assessment tool (AUSDRISK) is a short list of questions. It helps both health professionals and individuals to assess the risk of a person developing type 2 diabetes over the next 5 years. It consists of 10 questions with each question containing 2 options. Individuals who score 5 or less than 5 are at low risk. Individuals who score 6 to 11 are at intermediate risk of developing diabetes. While, Individuals who score 12 or more are at high risk of developing diabetes

  16th week

Secondary Outcomes (5)

• World Health Organization Quality of Life

  16th week

• 36-Item Short Form Survey

  16th week

• International Physical Activity Questionnaires

  16th week

• Rockport Walking Fitness Test

  16th week

• Borg rating of perceived exertion

  16th week

Study Arms (3)

Aerobics with Blood flow restriction

EXPERIMENTAL

This group will perform Aerobic exercises with Blood Flow Restriction training, patient education and dietary modifications will be given for pre diabetes

Other: Aerobic exercise with Blood flow restriction

Aerobics without Blood flow restriction

ACTIVE COMPARATOR

This group will perform Aerobic exercises without Blood Flow Restriction training, patient education and dietary modifications will be given for pre diabetes.

Other: Aerobic exercise without Blood flow restriction

Education and Dietary modifications

OTHER

This group will only receive education and dietary modifications for Pre-diabetes.

Other: Patient Education and dietary modification

Interventions

Aerobic exercise with Blood flow restriction OTHER

Experimental group will be given aerobic exercises with blood flow restriction training. For first four weeks, aerobic exercise will be performed for 25 min with 60-65 % of the maximum heart rate reserve (MHRR). During second four weeks, time of exercise will be 30 min with intensity 60-65% of the MHRR, and for third four weeks, time will be increased to 35 min and intensity will be raised up to 70-75% of the MHRR. . Arterial occlusion of 60% will be achieved by Blood Flow Restriction apparatus. Total intervention protocol for this group will be given for 12 weeks of duration 4 sessions per week with total 48 sessions.

Aerobics with Blood flow restriction

Aerobic exercise without Blood flow restriction OTHER

Active Comparator group will be given aerobic exercises. For first four weeks, aerobic exercise will be performed for 25 min with 60-65 % of the maximum heart rate reserve (MHRR). During second four weeks, time of exercise will be 30 min with intensity 60-65% of the MHRR, and for third four weeks, time will be increased to 35 min and intensity will be raised up to 70-75% of the MHRR. Total intervention protocol for this group will be given for 12 weeks of duration 4 sessions per week with total 48 sessions.

Aerobics without Blood flow restriction

Patient Education and dietary modification OTHER

Participants will individually instruct to reduce total energy intake and increase physical activity, aiming at a 5% reduction in body weight. The participants will be given pamphlets providing general information on pre diabetes and dietary modifications. Total intervention protocol for the group will be given for 12 weeks of duration 4 sessions per week with total 48 sessions.

Education and Dietary modifications

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both male \& female participants
• Age group between 30 to 60 years.
• Subjects clinically diagnosed with prediabetes (41-49 mmol/mol) after fasting blood sugar (110-125 mg/dl) and Hb1Ac (5.7%-6.4%) or assessed using the diabetes risk assessment tool as having high risk of developing diabetes in the next five years.
• Mean BMI for participants will be more than 22.
• Subjects able to understand simple instructions, independently or with assistance from their support person.

You may not qualify if:

• History of any cardiovascular problems that limited safe participation in aerobic or resistance exercise.
• Subjects who are unable to walk 30 min independently with or without a walking aid
• History of any psychological disorder.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Ahmad Poly care clinic, Faislabad

Faisalābad, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Exercise; Patient Education as Topic; Diet Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Nutrition Therapy; Therapeutics

Study Officials

• Muhammad Salman Bashir, Ph.D

  Riphah International University

  PRINCIPAL INVESTIGATOR

• Muhammad Abbas

  Riphah International University , QIE, Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: July 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)