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

October 23, 2024 updated by: Zhejiang Rongjun Hospital

Effect of Thera-Band Elastic Band-Assisted Progressive Resistance Training on Physical Health and Frailty Status in Patients with Diabetes Mellitus Complicated by Frailty Syndrome: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Jiaxing, Zhejiang, China
        • ZhejiangRongjun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Handgrip Strength
Time Frame: From enrollment to the end of treatment at 12 weeks.
Measured using an electronic hand muscle developer to assess muscle strength and physical function at baseline and after the 12-week intervention period.
From enrollment to the end of treatment at 12 weeks.
Usual Gait Speed
Time Frame: From enrollment to the end of treatment at 12 weeks.
Assessed using the 6-minute walk test to evaluate mobility and physical performance before and after the intervention.
From enrollment to the end of treatment at 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Physical Performance Battery
Time Frame: From enrollment to the end of treatment at 12 weeks.
Evaluated at baseline and after 12 weeks to measure balance, walking ability, and sit-to-stand performance. Scores range from 0 to 12, with higher scores indicating better physical performance.
From enrollment to the end of treatment at 12 weeks.
Fasting Blood Glucose
Time Frame: From enrollment to the end of treatment at 12 weeks.
Measured to assess glycemic control before and after treatment.
From enrollment to the end of treatment at 12 weeks.
2-Hour Postprandial Blood Glucose
Time Frame: From enrollment to the end of treatment at 12 weeks.
Evaluated to further understand blood glucose management following meals.
From enrollment to the end of treatment at 12 weeks.
Glycosylated Hemoglobin (HbA1c)
Time Frame: From enrollment to the end of treatment at 12 weeks.
Measured to assess long-term glycemic control.
From enrollment to the end of treatment at 12 weeks.
FRAIL Scale
Time Frame: From enrollment to the end of treatment at 12 weeks.
Used to evaluate frailty status before and after the intervention, with scores indicating robustness, pre-frailty, or frailty.The FRAIL scale scores range from 0 to 5, with higher scores indicating greater frailty.
From enrollment to the end of treatment at 12 weeks.
Rating of Perceived Exertion
Time Frame: Assessed after each training session, three times per week, throughout the 12-week treatment period.
Assessed to gauge participants' subjective fatigue and exertion levels during training sessions.
Assessed after each training session, three times per week, throughout the 12-week treatment period.
Geriatric Depression Scale-15
Time Frame: From enrollment to the end of treatment at 12 weeks.
Measured to evaluate participants' psychological state and levels of depression before and after the intervention.The GDS-15 score ranges from 0 to 15, with higher scores indicating worse depressive symptoms.
From enrollment to the end of treatment at 12 weeks.
Diabetes Distress Scale
Time Frame: From enrollment to the end of treatment at 12 weeks.
Used to assess participants' distress related to diabetes management before and after treatment.Scores range from 1 to 6, with higher scores indicating greater distress related to diabetes.
From enrollment to the end of treatment at 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Rongjun Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 23, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023 LSY No. (8)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

There is a plan to share individual participant data (IPD) collected in this study, specifically including all relevant data sets that underpin the published results. This will encompass demographic information, clinical assessments, treatment responses, and outcome measures related to blood glucose levels, handgrip strength, gait speed, and psychological evaluations. The data will be de-identified to ensure participant confidentiality and will be made available to qualified researchers upon request after the study's completion. Sharing these data aims to promote transparency, facilitate further research, and enhance the understanding of the effects of Thera-Band elastic band-assisted progressive resistance-exercise training on patients with diabetes mellitus and frailty syndrome. Access will be subject to ethical review and data sharing agreements to protect participant privacy.

IPD Sharing Time Frame

Individual participant data (IPD) and supporting information will be made available starting 6 months after the publication of the primary study results. This time frame allows for the completion of data analysis and publication processes. The data will remain accessible for a period of 5 years following the publication date to facilitate ongoing research and collaboration. During this time, interested researchers can request access to the IPD and any accompanying supporting information, subject to a data sharing agreement and ethical review to ensure participant confidentiality and proper use of the data.

IPD Sharing Access Criteria

Access to individual participant data (IPD) and supporting information will be granted to qualified researchers and institutions for legitimate scientific research purposes, such as further analyses that build on the original study findings. Requests for access must be submitted in writing and will be reviewed by an independent Data Access Committee (DAC) comprised of study investigators and ethical experts. The DAC will evaluate requests based on criteria including the scientific merit of the proposed analysis, adherence to ethical standards, and feasibility of data sharing. Approved researchers will be required to sign a data sharing agreement that outlines the terms of use, including ensuring participant confidentiality and data protection measures. Access will be facilitated through a secure online platform where data can be accessed in compliance with relevant regulations and guidelines.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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