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Weight Off-loading Training, Cardiovascular Indices, Diabetes

NCT06974422 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-05-15

No results posted yet for this study

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

Interventions

BEHAVIORAL

Partial weight bearing during aerobic exercise training

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

BEHAVIORAL

Full weight bearing during aerobic exercise training

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

DRUG

Regular oral anti-diabetic medications.

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

Sponsors & Collaborators

  • Umm Al-Qura University

    lead OTHER

Principal Investigators

  • ASHRAF AM ABDELAAL, Ph.D. · Associate Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2025-03-01
Completion
2025-05-01

Countries

  • Saudi Arabia

Study Locations

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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 NCT06974422 on ClinicalTrials.gov