Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Frailty Syndrome, Progressive Resistance Training, Thera-Band Elastic Band
Brief 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). 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.
Interventions
BEHAVIORALThera-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.
BEHAVIORALConventional 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.
Sponsors
Zhejiang Rongjun Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Handgrip Strength | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2-Hour Postprandial Blood Glucose | From enrollment to the end of treatment at 12 weeks. | Evaluated to further understand blood glucose management following meals. |
| Glycosylated Hemoglobin (HbA1c) | From enrollment to the end of treatment at 12 weeks. | Measured to assess long-term glycemic control. |
| FRAIL Scale | 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. |
| Short Physical Performance Battery | 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. |
| Geriatric Depression Scale-15 | 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. |
| Diabetes Distress Scale | 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. |
| Rating of Perceived Exertion | 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. |
| Fasting Blood Glucose | From enrollment to the end of treatment at 12 weeks. | Measured to assess glycemic control before and after treatment. |
Countries
China
Outcome results
None listed