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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Handgrip Strength
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Handgrip Strength
时间窗: 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
时间窗: 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.
次要结局
- Short Physical Performance Battery(From enrollment to the end of treatment at 12 weeks.)
- Fasting Blood Glucose(From enrollment to the end of treatment at 12 weeks.)
- 2-Hour Postprandial Blood Glucose(From enrollment to the end of treatment at 12 weeks.)
- Glycosylated Hemoglobin (HbA1c)(From enrollment to the end of treatment at 12 weeks.)
- FRAIL Scale(From enrollment to the end of treatment at 12 weeks.)
- Rating of Perceived Exertion(Assessed after each training session, three times per week, throughout the 12-week treatment period.)
- Geriatric Depression Scale-15(From enrollment to the end of treatment at 12 weeks.)
- Diabetes Distress Scale(From enrollment to the end of treatment at 12 weeks.)