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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
96
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: 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.
ZhejiangRongjun
Jiaxing, Zhejiang, China
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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 12 weeks.
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.
Time frame: From enrollment to the end of treatment at 12 weeks.
Fasting Blood Glucose
Measured to assess glycemic control before and after treatment.
Time frame: From enrollment to the end of treatment at 12 weeks.
2-Hour Postprandial Blood Glucose
Evaluated to further understand blood glucose management following meals.
Time frame: From enrollment to the end of treatment at 12 weeks.
Glycosylated Hemoglobin (HbA1c)
Measured to assess long-term glycemic control.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 12 weeks.
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