Weight Off-loading Training, Cardiovascular Indices, Diabetes

NCT06974422 | Completed DMC

• 1 other identifier: SNEZ070525
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Aims: To evaluate the effectiveness of partial weight-bearing during aerobic exercise training on cardiovascular disease risk and peripheral vascular function in patients with type 2 diabetes mellitus. Study design: A Randomized controlled study was conducted in the outpatient rehabilitation unit. Population: Forty-six participants (age 60 -70) with type 2 diabetes mellitus were recruited and randomly allocated into three groups: group A (100% weight-bearing; n=16), group B (75% weight-bearing; n=16), and group C (control group; n=14). Methods: The 2 study groups A and B, received three sessions per week of moderate intensity (60-75% heart rate reserve) aerobic exercise training, for 12 weeks, 50-60 minutes session duration (including warm-up and cool-down), on the antigravity treadmill. The cardiovascular disease risk (evaluated using the Atherosclerotic cardiovascular disease risk estimator plus tool) and peripheral vascular function (presented by ankle-brachial pressure index, calculated by subdividing the ankle systolic blood pressure by the brachial systolic blood pressure) are the main study outcomes. Variables were evaluated pre-study and post-study. Ethical concepts and institutional regulations were adhered during the study. Data were described as mean and standard deviation. Paired samples t-test and one-way ANOVA were used to test within and between-subjects assumptions, respectively, considering p\< 0.05 as the significance level.

Conditions

Cardiovascular Disease, Diabetes Mellitus Type 2; Peripheral Vascular Disorder Due to Diabetes Mellitus

Keywords

Exercise; Partial Weight-Bearing; Type 2 Diabetes Mellitus; Cardiovascular Disease; Ankle Brachial Index

Outcome Measures

Primary Outcomes (2)

• Change in the cardiovascular disease risk at 12-week.

  The cardiovascular disease risk was evaluated using the Atherosclerotic cardiovascular disease risk estimator plus tool, and was evaluated pre-study and at 12 weeks (end of the study).

  From enrollment to the end of treatment at 12 weeks.

• Change in the peripheral vascular function at 12-week.

  The peripheral vascular function (presented by ankle-brachial pressure index) was calculated by dividing the ankle systolic blood pressure by the brachial systolic blood pressure, and was evaluated pre-study and at 12 weeks (end of the study).

  From enrollment to the end of treatment at 12 weeks.

Study Arms (3)

Experimental Group-1 (group-A; 0% weight off-loading)

ACTIVE COMPARATOR

This group (100% weight-bearing group) received three sessions per week of moderate-intensity (60-75% heart rate reserve) aerobic exercise training, for 12 weeks, 50-60 minutes' session duration (including warm-up and cool-down), on the antigravity treadmill. Participants also received regular oral anti-diabetic medications.

Behavioral: Full weight bearing during aerobic exercise training

Experimental Group-2 (group-B; 25% weight off-loading)

EXPERIMENTAL

This group (27% weight-bearing group) received three sessions per week of moderate-intensity (60-75% heart rate reserve) aerobic exercise training, for 12 weeks, 50-60 minutes' session duration (including warm-up and cool-down), on the antigravity treadmill. Participants also received regular oral anti-diabetic medications.

Behavioral: Partial weight bearing during aerobic exercise training

Control group (Group; Non-exercising group)

OTHER

The control group participants received the same pre- and post-study evaluations as those for the study groups A and B, but did not participate in any aerobic exercise training on the antigravity treadmill. Participants only received regular oral anti-diabetic medications.

Drug: Regular oral anti-diabetic medications.

Interventions

Partial weight bearing during aerobic exercise training BEHAVIORAL

Partial weight bearing (25% weight support) during the moderate intensity aerobic exercise training on the antigravity treadmill

Also known as: Antigravity treadmill aerobic exercise training, partial weight offloading during aerobic exercise training

Experimental Group-2 (group-B; 25% weight off-loading)

Full weight bearing during aerobic exercise training BEHAVIORAL

Full weight bearing (100% weight loading, 0% weight support) during moderate intensity aerobic exercise training on the antigravity treadmill.

Experimental Group-1 (group-A; 0% weight off-loading)

Regular oral anti-diabetic medications. DRUG

Participants in the control group (group C) received regular oral anti-diabetic medications.

Control group (Group; Non-exercising group)

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes mellitus patients with 0.6\< ankle brachial index ≤ 0.9, treated only with oral hypoglycemic medications (Biguanide or Sulfonylureas + Biguanide), oral anti-diabetic drugs combination, with stable pharmacological treatment for at least 3 months before the study.
• Cognitively competent patients, able to walk independently with or without walking aids, assuming a Sedentary lifestyle (less than 30 minutes daily activity) during the last 6 months.
• Type 2 diabetes mellitus for more than 10 years, with glycosylated hemoglobin (HbA1c% %) level more than 7%, and fasting glucose level more than 7.0 mmol/L.
• Age range from 60 to 70 years, with normal/ accepted nutritional status (Mini Nutritional Assessment score more than 11).

You may not qualify if:

• Patients with Type 1 diabetes, younger than 60 or older than 70 years.
• Participation in any previous training program or diet regimen within the last 6 months.
• Patients with disturbed nutritional status (Mini Nutritional Assessment score less than 11).
• Serious musculoskeletal or cardiopulmonary disorders that can affect patient safety or the study results.

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Umm Al-Qura University

Mecca, Saudi Arabia

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• ASHRAF AM ABDELAAL, Ph.D.

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: August 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)