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

Study Overview
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Brief Summary
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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?

Detailed Description
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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.

Official Title
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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

Conditions
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Elastic Band Resistance Exercise With Comorbid Type 2 Diabetes Mellitus and Knee Osteoarthritis

Intervention / Treatment
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* Other: Elastic Band Resistance Exercise
* Other: active joint range-of-motion exercises and isometric contraction exercises


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>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. | Other: Elastic Band Resistance Exercise<br>* 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.<br>|
| Active Comparator: control group<br>The control group underwent active joint range-of-motion exercises and isometric contraction exercises. | Other: active joint range-of-motion exercises and isometric contraction exercises<br>* The control group underwent active joint range-of-motion exercises and isometric contraction exercises. The intervention regimens lasted 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c level | follow blood glucose cotrol | up to 12 weeks of intervention | 
| WOMAC physical function subscale scores | follow osteoarthritis physical function | up to 12 weeks of intervention | 
| 30-s chair stand test [CST] | follow low leg muscle strength | up to 12 weeks of intervention | 
| 3-m timed up and go test [TUG] | follow dynamic balance | up to 12 weeks of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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home-based exercise, resistance band, cartilage degeneration, glycated haemoglobin control, diabetes mellitus