Clinical trial 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
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elastic Band Resistance Exercise With Comorbid Type 2 Diabetes Mellitus and Knee Osteoarthritis
Keywords: home-based exercise, resistance band, cartilage degeneration, glycated haemoglobin control, diabetes mellitus
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: HbA1c level
timeFrame: up to 12 weeks of intervention
measure: WOMAC physical function subscale scores
timeFrame: up to 12 weeks of intervention
measure: 30-s chair stand test [CST]
timeFrame: up to 12 weeks of intervention
measure: 3-m timed up and go test [TUG]
timeFrame: up to 12 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Shu-Mei Chen
Study officials:
affiliation: Kaohsiung Medical University Department of Sports Medicine professor
name: Nai-Jen Chang
role: STUDY_DIRECTOR
References: