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Clinical Trials/NCT04026139
NCT04026139
Completed
Not Applicable

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

Shu-Mei Chen1 site in 1 country60 target enrollmentAugust 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Elastic Band Resistance Exercise With Comorbid Type 2 Diabetes Mellitus and Knee Osteoarthritis
Sponsor
Shu-Mei Chen
Enrollment
60
Locations
1
Primary Endpoint
HbA1c level
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2017
End Date
January 31, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shu-Mei Chen
Responsible Party
Sponsor Investigator
Principal Investigator

Shu-Mei Chen

ChangGungMH

Chang Gung Memorial Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

HbA1c level

Time Frame: up to 12 weeks of intervention

follow blood glucose cotrol

WOMAC physical function subscale scores

Time Frame: up to 12 weeks of intervention

follow osteoarthritis physical function

30-s chair stand test [CST]

Time Frame: up to 12 weeks of intervention

follow low leg muscle strength

3-m timed up and go test [TUG]

Time Frame: up to 12 weeks of intervention

follow dynamic balance

Study Sites (1)

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