Diabetes MellitusNCT06658106
Effect of Thera-Band Elastic Band-Assisted Progressive Resistance Training on Physical Health in Diabetes Patients with Frailty Syndrome
A study testing Thera-Band Elastic Band-Assisted Progressive Resistance Training and Conventional Diabetes Management in people with Diabetes Mellitus, run by Zhejiang Rongjun Hospital at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Thera-Band Elastic Band-Assisted Progressive Resistance Training and Conventional Diabetes Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Thera-Band Elastic Band-Assisted Progressive Resistance Training, Conventional Diabetes Management
- Keywords
- Diabetes Mellitus, Frailty Syndrome, Progressive Resistance Training, Thera-Band Elastic Band
- Medical subject headings
- Diabetes Mellitus, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thera-Band Elastic Band-Assisted Progressive Resistance TrainingBehavioural
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 ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Thera-Band Elastic Band-Assisted Progressive Resistance Training Group | Experimental | 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. Receives: Behavioral: Thera-Band Elastic Band-Assisted Progressive Resistance Training; Behavioral: Conventional Diabetes Management |
| Conventional Diabetes Management Group | Active comparator | 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. Receives: Behavioral: Conventional Diabetes Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handgrip Strength
Measured using an electronic hand muscle developer to assess muscle strength and physical function at baseline and after the 12-week intervention period.
Measured: From enrollment to the end of treatment at 12 weeks.
Usual Gait Speed
Assessed using the 6-minute walk test to evaluate mobility and physical performance before and after the intervention.
Measured: From enrollment to the end of treatment at 12 weeks.
Secondary outcomes (8)
Short Physical Performance Battery
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.
Measured: From enrollment to the end of treatment at 12 weeks.
Fasting Blood Glucose
Measured to assess glycemic control before and after treatment.
Measured: From enrollment to the end of treatment at 12 weeks.
2-Hour Postprandial Blood Glucose
Evaluated to further understand blood glucose management following meals.
Measured: From enrollment to the end of treatment at 12 weeks.
Glycosylated Hemoglobin (HbA1c)
Measured to assess long-term glycemic control.
Measured: From enrollment to the end of treatment at 12 weeks.
FRAIL Scale
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.
Measured: From enrollment to the end of treatment at 12 weeks.
Rating of Perceived Exertion
Assessed to gauge participants' subjective fatigue and exertion levels during training sessions.
Measured: Assessed after each training session, three times per week, throughout the 12-week treatment period.
Geriatric Depression Scale-15
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.
Measured: From enrollment to the end of treatment at 12 weeks.
Diabetes Distress Scale
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.
Measured: From enrollment to the end of treatment at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 Apr 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Rongjun Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658106
- Sponsor's protocol ID
- 2023 LSY No. (8)
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Ye M, Zhu Q, Yang H, Zhang L, Cai X. Effect of thera-band resistance training on diabetic patients with frailty syndrome. BMC Sports Sci Med Rehabil. 2025 Sep 29;17(1):284. doi: 10.1186/s13102-025-01350-9.
PubMed 41024136
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06658106
- Acronym / sponsor ID
- 2023 LSY No. (8)
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Frailty Syndrome, Progressive Resistance Training, Thera-Band Elastic Band
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Zhejiang Rongjun HospitalOther government
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Thera-Band Elastic Band-Assisted Progressive Resistance Training Group | Experimental | Behavioral: Thera-Band Elastic Band-Assisted Progressive Resistance Training, Behavioral: Conventional Diabetes ManagementIn 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. |
| Conventional Diabetes Management Group | Active comparator | Behavioral: Conventional Diabetes ManagementIn 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thera-Band Elastic Band-Assisted Progressive Resistance TrainingThera-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. | Behavioural | Thera-Band Elastic Band-Assisted Progressive Resistance Training Group |
| Conventional Diabetes ManagementConventional 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. | Behavioural | Conventional Diabetes Management Group, Thera-Band Elastic Band-Assisted Progressive Resistance Training Group |
Primary outcome
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.
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.
8 secondary outcomes
Short Physical Performance Battery
Time frame: 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.
2-Hour Postprandial Blood Glucose
Time frame: 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.
FRAIL Scale
Time frame: 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.
Geriatric Depression Scale-15
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Derived from this study: PubMed 41024136Ye M, Zhu Q, Yang H, Zhang L, Cai X. Effect of thera-band resistance training on diabetic patients with frailty syndrome. BMC Sports Sci Med Rehabil. 2025 Sep 29;17(1):284. doi: 10.1186/s13102-025-01350-9.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thera-Band Elastic Band-Assisted Progressive Resistance Training and Conventional Diabetes Management in people with Diabetes Mellitus, run by Zhejiang Rongjun Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Handgrip Strength (time frame: From enrollment to the end of treatment at 12 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06658106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.