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

Not Applicable

Completed

• Conditions: Elastic Band Resistance Exercise With Comorbid Type 2 Diabetes Mellitus and Knee Osteoarthritis
• Interventions: Other: Elastic Band Resistance Exercise; Other: active joint range-of-motion exercises and isometric contraction exercises

• Registration Number: NCT04026139
• Lead Sponsor: Shu-Mei Chen

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-08-01
• Primary Completion: 2018-01-31
• Study Completion: 2018-01-31
• Status Verified: 2019-07
• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-18
• Last Update Submitted: 2019-07-18
• Study First Posted: 2019-07-19
• Last Update Posted: 2019-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	Elastic Band Resistance Exercise	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.
control group	active joint range-of-motion exercises and isometric contraction exercises	The control group underwent active joint range-of-motion exercises and isometric contraction exercises.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Shu-Mei Chen; 🇨🇳 Kaohsiung, Taiwan