Muscle Strength Training for Older Adults With Type II Diabetes

Study Overview
=================
Brief Summary
-----------------
This randomised controlled trial aims to investigate a resistance training program for improving glycemic control, muscle mass, strength and functional performance in older patients with Type II Diabetes (T2 DM). 60 subjects will be randomly allocated to either a muscle strengthening group or a no exercise control group. Muscle strengthening group will receive resistance training 3 times per week (1 hour/session). The control group will not receive any training but can continue usual medical care and daily activities. Primary outcomes: glycemic control and lipid profile Secondary outcomes: muscle mass and strength, and functional capacity Data will be collected at baseline (pre-test) and after a 4-month intervention (post-test).

Detailed Description
-----------------
This study aims to investigate a resistance training program for improving glycemic control, muscle mass, strength and functional performance in older patients with Type II Diabetes (T2 DM). This is a single-blinded, randomized controlled trial. 60 subjects will be randomly allocated to either a muscle strengthening group or a no exercise control group. Information on demographic characteristics, body composition, muscle strength, functional capacity and glycemic control will be collected at baseline (pre-test) and after a 4-month intervention (post-test). Muscle strengthening group will receive resistance training 3 times per week (1 hour/session). The control group will not receive any training but can continue usual medical care and daily activities.

Official Title
-----------------
Effects of Muscle Strength Training on Glycemic Control, Muscle Mass, Muscle Strength and Functional Capacity in Older Adults With Type II Diabetes: A Randomised Controlled Trial

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Muscle Strengthening exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T2 DM 60-75 years old ability to perform exercise Exclusion Criteria: Advanced hypertension (≥ 160/100 mm Hg) severe obesity (BMI ≥ 48kg/m2) insulin pump user coronary heart disease history chronic obstructive pulmonary disease advanced neuropathy learning or mental disorder, or any other diseases that prevent subjects from exercising safely. Those who participate in regular resistance or aerobic exercises will also be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Muscle strengthening group<br>Participants will be required to perform muscle strengthening exercises 3 hours per week. Close kinetic chain exercises will be performed progressively according to the ACSM guidelines over the 4-month intervention period. The exercise intervention will be conducted by an experienced sports trainer. | Behavioral: Muscle Strengthening exercises<br>* Participants will be required to participate in resistance training 3 hours per week.<br>|
| No Intervention: Control group<br>No exercise training. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose level |  | 4 months | 
| Lipid profiles | HDL, LDL, Trig | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | Whole body | 4 months | 
| Muscle mass | Whole body | 4 months | 
| Functional performance | Walking ability | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resistance training, Diabetes Mellitus, blood-glucose control, Muscle, Function