Clinical trial NCT05411640: Effect of BFR Training on Glycemic Control, Functional Activity and Quality of Life in Individuals With Pre-diabetes
Official title: Effect of Blood Flow Restriction Training on Glycemic Control, Functional Activity and Quality of Life in Individuals With Prediabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Keywords: Prediabetic State
Glycemic Control
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: In 2021, a randomized control trial had been conducted to determine the effects of two methods of resistance training with and without blood flow restriction on coagulation indices and blood glucose levels in type 2 diabetic patients. This study recruited 41 patients with type 2 diabetes were randomly divided into three groups of resistance training with and without blood flow restriction and the control group. The subjects of the resistance training group with and without flow restriction performed the training for 8 weeks with intensities of 20, 40, 60, 80% of one maximum repetition and 20 and 30% of one maximum repetition, respectively. During this period, the subjects in the control group led a normal life and did not have a regular exercise program. Coagulation parameters, hematocrit and blood glucose levels were measured before and 48 hours after the last training session. This study concluded that 8 weeks of resistance training can prevent thrombosis and sudden onset of cardiovascular disease in patients with type 2 diabetes by reducing fibrinogen levels and increasing the Prothrombin Time index. This type of exercise also plays an insulin-like role by lowering blood sugar levels.

In 2019, a randomized control trial had been conducted to determine the Proximal, Distal, and Contralateral Effects of Blood Flow Restriction Training on the Lower Extremities. This study included 26 patients, providing 16 Blood Flow Restriction and 10 control patients. Patients were excluded for cardiac, pulmonary, or hematologic disease; pregnancy; or previous surgery in the extremity. The experimental group completed a standardized 6-week course of Blood Flow Restriction training. All participants of experimental group completed the following exercises at each training session: straight-leg raise hip flexion, side-lying hip abduction, long-arc quadriceps extension, and standing hamstring curl. Strength exercises were performed on both extremities using predetermined weight, calculated as 30% of 1-repitition (rep) maximum determined 1 week prior to the initiation of training Data collected at baseline and completion included limb circumferences and strength testing. This study concluded that low-load Blood Flow Restriction training increased muscle strength and limb circumference more than high- load Blood Flow Restriction training. Both the proximal and distal muscle groups were strengthened by Blood Flow Restriction exercise. A systemic or crossover effect could be confirmed by gains in the contralateral extremity.

In 2019, a randomized control trial had been conducted to determine the effects of Low-load blood flow restriction training that induces similar morphological and mechanical Achilles' tendon adaptations as compared with high-load resistance training. This study included 55 male volunteers those were randomly allocated into the following three groups: low load- Blood Flow Restriction, high load and a non-exercising control group. The low load- Blood Flow Restriction and high load groups completed a resistance training program for 14 week, and tendon morphology, mechanical as well as material properties, and muscle cross- sectional area and isometric strength were assessed before and after the intervention. This study concluded that the adaptive change in Achilles' tendon properties following low-load resistance training with partial vascular occlusion appears comparable to that evoked by high-load resistance training.

In 2018, a randomized control trial had been conducted to determine the effects of lower body blood flow restriction training may induce remote muscle strength adaptations in an active unrestricted arm. 24 participants were recruited in this study which were divided in two groups. an experimental Blood Flow Restriction group (EXP; n = 12) or a non- Blood Flow Restriction control group (CON; n = 12) completed 7-weeks of resistance training comprising three sets of unilateral bicep curls \[50% 1-repetition maximum (1-RM)\], then four sets of bilateral knee extension and flexion exercises (30% 1-RM). Experimental group performed leg exercises with an applied Blood Flow Restriction (60% limb occlusion pressure). 1-RM strength was measured using bilateral leg exercises and unilateral bicep curls in both trained and untrained arms. Muscle CSA was measured via peripheral quantitative computed tomography in the dominant leg and both arms. This study concluded that Blood Flow Restriction training increased trained arm strength more than the contralateral untrained arm, and the trained arm of control.

In 2018, a randomized control trial had been conducted to determine the effects of benefits of Resistance Training with Blood Flow Restriction in Knee Osteoarthritis. This study recruited forty-eight women with knee OA were randomized into one of the three groups: low-intensity resistance training (30% one repetition maximum 1-RM) associated (BFRT) or not (LI-RT) with partial blood flow restriction, and high-intensity resistance training (HI- RT: 80% 1-RM). Patients underwent a 12-week supervised training program and were assessed for lower-limb 1-RM, quadriceps cross-sectional area (CSA), functionality (timed stands test - TST and timed-up-and-go test - TUG), and disease-specific inventory (Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC) before (PRE) and after the protocol (POST). This study concluded that BFRT and HI-RT were similarly effective in increasing muscle strength, quadriceps muscle mass, and functionality in knee OA patients. Importantly, BFRT was also able to improve pain while inducing less joint stress, emerging as a feasible and effective therapeutic adjuvant in OA management.

In previous studies, blood flow restriction technique has been used in clinical practice to increase the muscle mass and muscle strength. Literature is limited regarding the effects of Blood Flow Restriction to treat and control pre diabetes. Moreover, there are very less evidence that studied about the effect of Blood Flow Restriction to prevent the progression to diabetes mellites in pre-diabetic participants. Therefore, current study is designed to determine the effects of blood flow restriction training on glycemic control in individuals with prediabetes.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Fasting Blood Sugar Level
timeFrame: 16th week
measure: Hemoglobin A1c (HbA1c) test
timeFrame: 16th week
measure: Australian type 2 diabetes risk assessment tool (AUSDRISK)
timeFrame: 16th week
Secondary outcomes:
measure: World Health Organization Quality of Life
timeFrame: 16th week
measure: 36-Item Short Form Survey
timeFrame: 16th week
measure: International Physical Activity Questionnaires
timeFrame: 16th week
measure: Rockport Walking Fitness Test
timeFrame: 16th week
measure: Borg rating of perceived exertion
timeFrame: 16th week
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Ahmad Poly care clinic, Faislabad
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Salman Bashir, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah International University , QIE, Campus
name: Muhammad Abbas
role: PRINCIPAL_INVESTIGATOR
References: