The Effect of Blood Flow Restriction Training on Glycemic Control Among Type 2 Diabetes Patients

NCT ID: NCT04946799

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-01-30

Brief Summary

Blood flow restriction training (BFRT) combined with resistance or aerobic exercise has been shown to improve the glucose uptake in humans. In addition, BFRT represents a low-load, alternative exercise program for type 2 diabetes patients who often have reduced physical fitness. However, it is not clear to what extent could BFRT improve glycemic control among patients with type 2 diabetes. This pilot randomized-controlled trial aims to investigate the effect of a 12-week, low-intensity BFRT on glycemic control among patients with type 2 diabetes, compared to medium-high intensity aerobic exercise or low-intensity exercise without BFRT.

Detailed Description

Objectives:

The pilot randomized study aims to explore the effects of blood flow restriction combined with aerobic training (BFRT) on the glucose and lipid metabolism indexes and vascular endothelial factors of type 2 diabetes, by comparing it with traditional low-intensity and high-intensity aerobic training. It aims to evaluate the effectiveness of BFRT in glycemic control of type 2 diabetes patients.

Study Population:

A total of 60 patients with type 2 diabetes who are 50-65 years old at the Maigaoqiao Community Health Service Center, Qixia District, Nanjing, China, with a course of type 2 diabetes of 2-10 years will be included as the participants.

Randomization:

Participants will be stratified by baseline hemoglobin A1c (HbA1c) and age, they will be randomly assigned into three groups with a block size of six. The study groups are: 1) low-intensity training combined with blood flow restriction group (LI-BFR group, 40% heart rate reserve combined with 50% arterial occlusion pressure, n=20) 2)high-intensity aerobic exercise group (HI group, 70% heart rate reserve, n=20) 3) Low-intensity group (LI group, 40% heart rate reserve, n=20).

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Low-intensity training combined with blood flow restriction group (LI-BFR)

Group Type: EXPERIMENTAL

Low-intensity training combined with blood flow restriction (LI-BFR)

Intervention Type: BEHAVIORAL

Participants (n=20) receives low intensity exercise intervention on a cycle ergometer (at 40% of heart rate reserve), with compression belts attached on both thighs, during exercise the belts are inflated with 50% of the participant's arterial occlusion pressure. Exercise is conducted during daytime, 3 times per week, for 12 weeks at Nanjing Maigaoqiao Community Health Service Center. Each exercise session contains 6 sections, each section lasts for 5 minutes, followed with a 1-minute rest period. The compression belt is deflated during the rest period. At least two trained research assistants supervise the exercise in each session. Instant heart rate during exercise is measured with heart rate monitor for each participant.

High-intensity aerobic exercise group (HI)

Group Type: ACTIVE_COMPARATOR

High-intensity aerobic exercise (HI)

Intervention Type: BEHAVIORAL

Participants (n=20) receives high intensity aerobic exercise intervention on a cycle ergometer (at 70% of heart rate reserve). Exercise is conducted during daytime, 3 times per week, for 12 weeks at Nanjing Maigaoqiao Community Health Service Center. Each exercise session contains 6 sections, each section lasts for 5 minutes, followed with a 1-minute rest period. At least two trained research assistants supervise the exercise in each session. Instant heart rate during exercise is measured with heart rate monitor for each participant.

Low intensity group (LI)

Group Type: PLACEBO_COMPARATOR

Low intensity exercise (LI)

Intervention Type: BEHAVIORAL

Participants (n=20) receives low intensity exercise intervention on a cycle ergometer (at 40% of heart rate reserve). Exercise is conducted during daytime, 3 times per week, for 12 weeks at Nanjing Maigaoqiao Community Health Service Center. Each exercise session contains 6 sections, each section lasts for 5 minutes, followed with a 1-minute rest period. At least two trained research assistants supervise the exercise in each session. Instant heart rate during exercise is measured with heart rate monitor for each participant.

Interventions

Low-intensity training combined with blood flow restriction (LI-BFR)

Participants (n=20) receives low intensity exercise intervention on a cycle ergometer (at 40% of heart rate reserve), with compression belts attached on both thighs, during exercise the belts are inflated with 50% of the participant's arterial occlusion pressure. Exercise is conducted during daytime, 3 times per week, for 12 weeks at Nanjing Maigaoqiao Community Health Service Center. Each exercise session contains 6 sections, each section lasts for 5 minutes, followed with a 1-minute rest period. The compression belt is deflated during the rest period. At least two trained research assistants supervise the exercise in each session. Instant heart rate during exercise is measured with heart rate monitor for each participant.

Intervention Type: BEHAVIORAL

High-intensity aerobic exercise (HI)

Participants (n=20) receives high intensity aerobic exercise intervention on a cycle ergometer (at 70% of heart rate reserve). Exercise is conducted during daytime, 3 times per week, for 12 weeks at Nanjing Maigaoqiao Community Health Service Center. Each exercise session contains 6 sections, each section lasts for 5 minutes, followed with a 1-minute rest period. At least two trained research assistants supervise the exercise in each session. Instant heart rate during exercise is measured with heart rate monitor for each participant.

Intervention Type: BEHAVIORAL

Low intensity exercise (LI)

Participants (n=20) receives low intensity exercise intervention on a cycle ergometer (at 40% of heart rate reserve). Exercise is conducted during daytime, 3 times per week, for 12 weeks at Nanjing Maigaoqiao Community Health Service Center. Each exercise session contains 6 sections, each section lasts for 5 minutes, followed with a 1-minute rest period. At least two trained research assistants supervise the exercise in each session. Instant heart rate during exercise is measured with heart rate monitor for each participant.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• type 2 diabetes patients diagnosed by at least one of these criteria: 1) random blood glucose >= 11.1mmol/L; 2) fasting blood glucose >= 7.0 mmol/L; 3) 2-hr post oral glucose tolerance test blood glucose >= 11.1mmol/L; 4) hemoglobin A1c >= 6.5%.
• aged between 50-65 years at baseline
• disease course of type 2 diabetes between at least 1 year

Exclusion Criteria

• type 1 diabetes
• fasting blood glucose > 16.7 mmol/L, or suffers frequent hypoglycemia, or have significant glucose fluctuations considered by the physician
• body mass index > 33 kg/m2
• severe diabetes complications, including cardiovascular diseases, cerebrovascular diseases, diabetic retinopathy, kidney diseases, diabetic ketoacidosis, and diabetic foot ulcers
• neuromuscular disorders, sarcopenia, severe osteoporosis, dementia
• have regular moderate-intensive exercise habit
• resting systolic blood pressure >= 160 mmHg or resting diastolic blood pressure >= 100 mmHg
• abnormal electrocardiogram
• other comorbidities or medications irrelevant to diabetes treatment that may influence glycemia during the past 6 months

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Sport Institute

UNKNOWN

Sponsor Role: collaborator

Nanjing Maigaoqiao Community Health Service Center

UNKNOWN

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Zhao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nanjing Sport Institute

Xiao Tan, PhD

Role: STUDY_DIRECTOR

Uppsala University

Locations

Nanjing Maigaoqiao Community Healthcare Center

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

HK-LLWYH-202002

Identifier Type: -

Identifier Source: org_study_id