A Theory-based Home-based Multi-component Exercise Training Among Older Adults With Type 2 Diabetes Mellitus

NCT06393244 | Recruiting

• 1 other identifier: L2023SYSU-HL-052
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a theory-based home-based multi-component exercise training works to prevent sarcopenia in older adults with type 2 diabetes mellitus. It will also learn about the safety of the theory-based home-based multi-component exercise training. The main questions it aims to answer are:

• Whether a 12-week theory-based home-based MCE program is effective in decreasing the risk of developing sarcopenia, as well as improving physical activity, glycaemic control, muscle mass, muscle strength, physical performance, cognitive function, depressive mood, and quality of life among the Chinese community-dwelling older patients with T2DM.
• What are the underlying mechanisms of the exercise intervention. Researchers will compare the MCE program to a waiting list control group to see if the MCE program works to prevent sarcopenia. Participants will: · Take a MCE program or a waiting list for 6 months

Conditions

Diabetes Mellitus Type 2; Sarcopenia

Keywords

Type 2 diabetes mellitus; The risk of developing Sarcopenia; Multi-component exercise program; Interaction model of client health behavior

Outcome Measures

Primary Outcomes (2)

• the risk of developing sarcopenia

  The change of the scores of Strength, Assistance with Walking, Rise from a Chair, Climb Stairs and Falls (SARC-F) or Assistance with Walking, Rise from a Chair, Climb Stairs and Falls, Calf Circumference (SARC-CalF) or calf circumference (CC) among older adults with type 2 diabetes mellitus during the intervention period and follow-up period. The SARC-F consists of 5 items, which total scores ≥4 points can be judged as patients with high risk of developing sarcopenia. The total scores of SARC-CalF range from 0 to 20, with total scores ≥11 points indicating patients with high risk of developing sarcopenia. AWGS 2019 recommends CC \<34cm for males and CC \<33cm for females to indicate a high risk of developing sarcopenia among Asian populations.

  baseline, 3 months, 6 months

• the level of physical activity

  The change of the scores of physical activity scale for the elderly (PASE) among older adults with type 2 diabetes mellitus during the intervention period and follow-up period. This scale comprises 10 items across three dimensions: leisure, housework, and occupational physical activity. The total scores range from 0 to 500, with higher total scores indicating higher physical activity among the older adults.

  baseline, 3 months, 6 months

Secondary Outcomes (8)

• Fasting blood glucose (FBG)

  baseline, 3 months, 6 months

• muscle mass,

  baseline, 3 months, 6 months

• muscle strength

  baseline, 3 months, 6 months

• physical performance

  baseline, 3 months, 6 months

• cognitive function

  baseline, 3 months, 6 months

Study Arms (2)

the intervention group

EXPERIMENTAL

a theory-based home-based multi-component exercise training

Behavioral: a theory-based home-based multi-component exercise training

the waiting list control group

NO INTERVENTION

the waiting list control

Interventions

a theory-based home-based multi-component exercise training BEHAVIORAL

The participants in the intervention group will receive a 12-week theory-based home-based MCE program, which consists of three phases: exercise mobilization phase, exercise preparation phase (exercise instructions and exercise plan determination), and home-based autonomous exercise training. Structured guidelines have been developed for the intervention by the research team. This allowed interveners to deliver the intervention in a structured way with the same dosage.

the intervention group

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are community-dwelling older adults aged 60 years or above and have been diagnosed with T2DM;
• are able to communicate in Chinese;
• have a smartphone to receive intervention materials and messages;
• provide written informed consent for voluntary participation in this study.

You may not qualify if:

• meet the AWGS 2019 diagnostic criteria for sarcopenia;
• are currently participating in any other exercise intervention program or within the last 6 months;
• have any contraindication to exercise training according to the American College of Sports Medicine (ACSM) or are medically prohibited from participating in exercise;
• have a history of cognitive disorders or psychopathy, as identified in their medical records;
• severe visual or hearing problems,

Sponsors & Collaborators

• Cheng Li: lead

Study Sites (1)

Yuexiu District Baiyun Street community health service center

Guangzhou, Guangdong, 510003, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Sarcopenia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Cheng Li, PhD

CONTACT

+86 13825020897; chengli5@mail.sysu.edu.cn

Liu Hui

CONTACT

17812003630; liuh377@mail2.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 1, 2024
• Study Start: March 15, 2024
• Primary Completion: March 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: After the publication of the study
• Access Criteria: Researchers should contact the PI for approval of the study protocol.

Locations

CN (1)