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.

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.

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.

Individual participant data (IPD) and supporting information will be made available starting 6 months after the publication of the primary study results. This time frame allows for the completion of data analysis and publication processes. The data will remain accessible for a period of 5 years following the publication date to facilitate ongoing research and collaboration. During this time, interested researchers can request access to the IPD and any accompanying supporting information, subject to a data sharing agreement and ethical review to ensure participant confidentiality and proper use of the data.

Access to individual participant data (IPD) and supporting information will be granted to qualified researchers and institutions for legitimate scientific research purposes, such as further analyses that build on the original study findings. Requests for access must be submitted in writing and will be reviewed by an independent Data Access Committee (DAC) comprised of study investigators and ethical experts. The DAC will evaluate requests based on criteria including the scientific merit of the proposed analysis, adherence to ethical standards, and feasibility of data sharing. Approved researchers will be required to sign a data sharing agreement that outlines the terms of use, including ensuring participant confidentiality and data protection measures. Access will be facilitated through a secure online platform where data can be accessed in compliance with relevant regulations and guidelines.

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.