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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This clinical trial will utilize a parallel study design, wherein participants will be randomly assigned to one of two groups: the research group receiving Thera-Band elastic band-assisted progressive resistance training (PRT) and the control group receiving conventional diabetes management. Each group will be treated independently throughout the study duration of 12 weeks. The outcomes of interest will be assessed at baseline and after the intervention period to determine the effectiveness of the exercise program in improving physical health and reducing frailty in older adults with diabetes mellitus. This design allows for a direct comparison between the intervention and control groups, providing robust data on the efficacy of the Thera-Band PRT approach.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

In this clinical trial, there will be no masking of participants, care providers, investigators, or outcomes assessors. All parties involved will be aware of the interventions assigned to participants. This decision was made to facilitate adherence to the Thera-Band elastic band-assisted progressive resistance training program and to ensure that the research team can monitor the participants effectively throughout the intervention. While this approach allows for clear communication and immediate feedback regarding the exercise protocol, it may introduce bias in the assessment of outcomes. However, objective measures such as blood glucose levels and physical performance assessments will be used to minimize this potential bias.

Study Groups

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Thera-Band Elastic Band-Assisted Progressive Resistance Training Group

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.

Group Type EXPERIMENTAL

Thera-Band Elastic Band-Assisted Progressive Resistance Training

Intervention Type BEHAVIORAL

Thera-Band Elastic Band-Assisted Progressive Resistance Training: This intervention involves a structured exercise program using Thera-Band elastic bands for resistance training, conducted three times a week for 12 weeks. Each session lasts approximately 50 minutes and includes exercises targeting major muscle groups, such as upper arms, shoulders, chest, lumbar, and lower limbs. Participants will perform each exercise for 8-12 repetitions in 2-3 sets with 1-minute intervals, aiming for an intensity of 60%-80% of their maximum heart rate. The program is designed to improve strength, balance, and overall physical function, thereby reducing frailty in older adults with diabetes.

Conventional Diabetes Management

Intervention Type BEHAVIORAL

Conventional Diabetes Management: Participants in this arm will receive standard care for diabetes management, which includes health education covering diet, medication adherence, exercise recommendations, and routine health monitoring. This arm serves as a comparator to assess the effectiveness of the progressive resistance training intervention.

Conventional Diabetes Management Group

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.

Group Type ACTIVE_COMPARATOR

Conventional Diabetes Management

Intervention Type BEHAVIORAL

Conventional Diabetes Management: Participants in this arm will receive standard care for diabetes management, which includes health education covering diet, medication adherence, exercise recommendations, and routine health monitoring. This arm serves as a comparator to assess the effectiveness of the progressive resistance training intervention.

Interventions

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Thera-Band Elastic Band-Assisted Progressive Resistance Training

Thera-Band Elastic Band-Assisted Progressive Resistance Training: This intervention involves a structured exercise program using Thera-Band elastic bands for resistance training, conducted three times a week for 12 weeks. Each session lasts approximately 50 minutes and includes exercises targeting major muscle groups, such as upper arms, shoulders, chest, lumbar, and lower limbs. Participants will perform each exercise for 8-12 repetitions in 2-3 sets with 1-minute intervals, aiming for an intensity of 60%-80% of their maximum heart rate. The program is designed to improve strength, balance, and overall physical function, thereby reducing frailty in older adults with diabetes.

Intervention Type BEHAVIORAL

Conventional Diabetes Management

Conventional Diabetes Management: Participants in this arm will receive standard care for diabetes management, which includes health education covering diet, medication adherence, exercise recommendations, and routine health monitoring. This arm serves as a comparator to assess the effectiveness of the progressive resistance training intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No