Clinical trial NCT06658106: Effect of Thera-Band Elastic Band-Assisted Progressive Resistance Training on Physical Health in Diabetes Patients with Frailty Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Frailty Syndrome
Progressive Resistance Training
Thera-Band Elastic Band
Lead sponsor: Zhejiang Rongjun Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-26
Enrollment: 96
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Handgrip Strength
timeFrame: From enrollment to the end of treatment at 12 weeks.
measure: Usual Gait Speed
timeFrame: From enrollment to the end of treatment at 12 weeks.
Secondary outcomes:
measure: Short Physical Performance Battery
timeFrame: From enrollment to the end of treatment at 12 weeks.
measure: Fasting Blood Glucose
timeFrame: From enrollment to the end of treatment at 12 weeks.
measure: 2-Hour Postprandial Blood Glucose
timeFrame: From enrollment to the end of treatment at 12 weeks.
measure: Glycosylated Hemoglobin (HbA1c)
timeFrame: From enrollment to the end of treatment at 12 weeks.
measure: FRAIL Scale
timeFrame: From enrollment to the end of treatment at 12 weeks.
measure: Rating of Perceived Exertion
timeFrame: Assessed after each training session, three times per week, throughout the 12-week treatment period.
measure: Geriatric Depression Scale-15
timeFrame: From enrollment to the end of treatment at 12 weeks.
measure: Diabetes Distress Scale
timeFrame: From enrollment to the end of treatment at 12 weeks.
Other outcomes:
Locations:
city: Jiaxing
country: China
facility: ZhejiangRongjun
state: Zhejiang
Study officials:
References: