Effect of Thera-Band Elastic Band-Assisted Progressive Resistance Training on Physical Health in Diabetes Patients with Frailty Syndrome

Zhejiang Rongjun Hospital

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Behavioral: Conventional Diabetes Management; Behavioral: Thera-Band Elastic Band-Assisted Progressive Resistance Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06658106

2023 LSY No. (8)

Details and patient eligibility

About

Goal: The goal of this clinical trial is to evaluate the effectiveness of Thera-Band elastic band-assisted progressive resistance training (PRT) in improving physical health and reducing frailty in older adults with diabetes mellitus (DM) complicated by frailty syndrome (FS).

Main Questions:

Does Thera-Band elastic band-assisted PRT lower blood glucose levels in patients with DM? Does Thera-Band elastic band-assisted PRT improve physical function, as measured by handgrip strength and gait speed, in patients with FS? If there is a comparison group: Researchers will compare the Thera-Band elastic band PRT group to the conventional treatment group to see if the PRT intervention leads to greater improvements in physical health and frailty status.

Participants will:

Undergo Thera-Band elastic band-assisted progressive resistance training for 12 weeks, attending sessions three times a week.

Complete assessments of their blood glucose levels and physical function before and after the intervention.

Provide feedback on their fatigue, psychological state, and any adverse reactions during the training period.

Full description

This clinical trial aims to assess the effects of Thera-Band elastic band-assisted progressive resistance training (PRT) on the physical health of patients with diabetes mellitus (DM) complicated by frailty syndrome (FS). The trial will involve 96 participants aged 60 years and older, diagnosed with type 2 DM and identified as frail based on the Tilburg Frailty Indicator (TFI).

Participants will be randomly assigned to either the research group, receiving Thera-Band PRT, or a control group receiving conventional diabetes management. The PRT sessions will occur three times a week for 12 weeks, focusing on strength training exercises targeting major muscle groups using elastic bands of varying resistance. Training sessions will include upper and lower body exercises, ensuring participants work at 60%-80% of their maximum heart rate.

Primary outcomes will include changes in fasting blood glucose levels, handgrip strength (HS), and usual gait speed (UGS), assessed before and after the intervention. The Short Physical Performance Battery (SPPB) will evaluate overall physical function, while the FRAIL scale will assess frailty status. Psychological assessments will be conducted using the Geriatric Depression Scale-15 (GDS-15) and the Diabetes Distress Scale (DDS) to measure mental well-being.

Adverse events, such as injuries or discomfort during training, will be monitored throughout the study to ensure participant safety. This trial will contribute valuable clinical evidence regarding the effectiveness of elastic band-assisted PRT in enhancing physical health and reducing frailty in older adults with diabetes, ultimately informing best practices for managing this vulnerable patient population.

Enrollment: 96 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with Type 2 Diabetes Mellitus (T2DM).
• Fasting blood glucose level of less than 16.7 mmol/L.
• Frailty score of 4 points or higher on the Tilburg Frailty Indicator (TFI).
• Aged 60 years or older.
• Muscle strength rated at level 4 or higher.
• No participation in regular exercise in the past.

Exclusion criteria

• Presence of serious heart conditions, such as severe heart failure or significant heart disease.
• Loss of consciousness (e.g., being excessively sleepy or in a coma).
• Diagnosis of severe Alzheimer's disease or other significant cognitive impairments.
• Physical disabilities that would prevent participation in exercise.
• Diagnosis of severe osteoporosis (weak bones).
• Communication barriers that prevent understanding or cooperation with the study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Thera-Band Elastic Band-Assisted Progressive Resistance Training Group

Experimental group

Description:

In the Thera-Band Elastic Band-Assisted Progressive Resistance Training Group, participants will engage in a structured exercise program utilizing Thera-Band elastic bands for resistance training. The intervention will occur three times a week for 12 weeks, with each session lasting approximately 50 minutes. Exercises will target major muscle groups, including upper and lower limbs, and will be designed to improve strength, balance, and overall physical function. Participants will be instructed to exercise at 60%-80% of their maximum heart rate to ensure an effective training intensity. The program aims to enhance physical health, reduce frailty, and improve quality of life for older adults with diabetes mellitus and frailty syndrome. Participants will receive guidance from trained exercise instructors and will be monitored for any adverse reactions during the training sessions.

Treatment:

Behavioral: Conventional Diabetes Management

Behavioral: Thera-Band Elastic Band-Assisted Progressive Resistance Training

Conventional Diabetes Management Group

Active Comparator group

Description:

In the Conventional Diabetes Management Group, participants will receive standard care for diabetes management, which includes basic health education and guidance on diet, exercise, medication adherence, and daily care practices. This group will not engage in the Thera-Band exercise program but will continue their usual activities and follow-up care as prescribed by their healthcare providers. The aim of this arm is to provide a comparison to the experimental group regarding the effectiveness of the elastic band-assisted progressive resistance training on physical health and frailty outcomes. Participants will be monitored for their blood glucose levels and overall health status throughout the study period, and any changes in their condition will be documented.

Treatment:

Behavioral: Conventional Diabetes Management