The Effects of a Multimodal Exercise Program on Physical Performance and Muscle Function in Middle-Aged Patients With Type 2 Diabetes: A Multicenter Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Design: This is a multicenter randomized controlled trial. * Participants: The study plans to recruit 66 adults, aged 45 to 64, with a confirmed diagnosis of T2DM. * Group Assignment: Participants will be randomly assigned to either a control group or an intervention group. * Control Group: Participants will receive only a Nutrition and Muscle Health Education Sheet and continue with their routine health management based on existing medical advice. * Intervention Group: Participants will receive the same leaflet along with a Diabetes and Muscle Health Handbook and will take part in a 12-week multimodal exercise program. * Assessments: All participants will be assessed at baseline, week 6, and week 12. Outcome Measures * Primary Outcomes: o Physical Function: Short Physical Performance Battery (SPPB), Five-Times Sit-to-Stand Test (5TSTS), handgrip strength, and Skeletal Muscle Mass Index (SMI). * Secondary Outcomes: * Metabolic Control: Glycated hemoglobin (HbA1c). * Quality of Life: SF-12 Quality of Life questionnaire. * Sarcopenia Risk: Evaluated by the SARC-CalF questionnaire. Expected Outcomes This study aims to provide an evidence-based and feasible multimodal exercise prescription for middle-aged adults with T2DM. The findings are expected to support early intervention strategies for healthy aging and serve as a valuable reference for clinical practice and the development of public health policies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 64
Healthy Volunteers: f
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• Diagnosed with Type 2 Diabetes Mellitus and on stable oral hypoglycemic medication.

⁃ Middle-aged adults between 45 and 64 years old.

⁃ Able to communicate in Mandarin or Taiwanese.

⁃ Willing to provide informed consent or have informed consent obtained from a proxy

Locations
Other Locations
Taiwan
Chung Shan Medical University Hospital
RECRUITING
Taichung
Contact Information
Primary
yueh chu WU YUEH CHU
yueh.chu46240@gmail.com
886-952680613
Time Frame
Start Date: 2025-08-18
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 66
Treatments
Experimental: A Multimodal Exercise Intervention
Participants in this group will participate in a 12-week multimodal exercise program. The program includes supervised training sessions, home-based exercises, and digital support. They will also receive a Diabetes and Muscle Health Handbook to guide their training. The goal is to evaluate the effectiveness of this program on muscle function, physical performance, and metabolic control.
No_intervention: control group
Participants in this group will serve as the control for the study. At the beginning of the study, they will only receive a Nutrition and Muscle Health Education Sheet. They will not participate in the multimodal exercise program and will continue with their usual health management based on existing medical advice.
Related Therapeutic Areas
Sponsors
Leads: yueh chu wu

This content was sourced from clinicaltrials.gov

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