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OpenTrials
Completed

NCT Number: NCT04026139

Elastic Band Resistance Exercise on Glycated Haemoglobin and Muscle Strength, Balance, and Physical Function in Patients With Comorbid Type 2 Diabetes Mellitus and Knee Osteoarthritis

Whether elastic band resistance exercise (EBRE) as a home-based rehabilitation routine can control the glycated heamoglobin (HbA1c) level and improve the muscle strength, dynamic balance, and physical function in older patients with comorbid T2DM and knee OA?

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Key information

About this study

Design: Randomised controlled trial. Participants: Seventy patients diagnosed with T2DM together with knee OA. Intervention: Patients in the experimental and control group were instructed by clinical staff to perform home-based exercises and followed up through phone calls. The experimental group performed exercises using an elastic resistance band with 10 repetitions/set × 5 sets/day × 3 days/week. The control group underwent active joint range-of-motion exercises and isometric contraction exercises. The intervention regimens lasted 12 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria for this study were as follows: age between 60 and 70 years; comorbid T2DM and knee OA diagnosed by a physician; and Kellgren and Lawrence (K&L) grade <3 based on the findings of plain radiographs.

Exclusion criteria

  • Exclusion criteria were as follows: inability to perform any self-activity; DM with complications, such as lower extremity neuropathy, retinopathy, stroke, foot wounds, or amputations; K&L grade >3, hip or knee arthroplasty; history of myocardial infarction; uncontrolled liver and kidney disease; and uncontrolled hypertension.

Treatment and study plan

Elastic Band Resistance Exercise

Other

Patients in the experimental and control group were instructed by clinical staff to perform home-based exercises and followed up through phone calls. The experimental group performed exercises using an elastic resistance band with 10 repetitions/set × 5 sets/day × 3 days/week.

active joint range-of-motion exercises and isometric contraction exercises

Other

The control group underwent active joint range-of-motion exercises and isometric contraction exercises. The intervention regimens lasted 12 weeks.

Primary outcomes

  1. HbA1c level

    Time frame: up to 12 weeks of intervention

    follow blood glucose cotrol

  2. WOMAC physical function subscale scores

    Time frame: up to 12 weeks of intervention

    follow osteoarthritis physical function

  3. 30-s chair stand test [CST]

    Time frame: up to 12 weeks of intervention

    follow low leg muscle strength

  4. 3-m timed up and go test [TUG]

    Time frame: up to 12 weeks of intervention

    follow dynamic balance

Sponsors and collaborators

Lead sponsor

Shu-Mei Chen

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 19, 2019
Registry last updated
Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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