The RESET study - version 1.0

  • Research type

    Research Study

  • Full title

    The effect of a multi-modal exercise intervention on patients with type 2 diabetes and impaired physical functioning: a randomised controlled trial

  • IRAS ID

    261435

  • Contact name

    Thomas Yates

  • Contact email

    ty20@leicester.ac.uk

  • Sponsor organisation

    The University of Leicester

  • Duration of Study in the UK

    1 years, 0 months, 1 days

  • Research summary

    Research Summary

    Adults with type 2 diabetes mellitus (T2DM) have physiologic exercise limitations and decreased cardiorespiratory fitness which may contribute to frailty. Frailty is a pre-disability condition linked to reduced physical function. While frailty and physical impairment is more prevalent in an older population, it has been shown that it is also common in middle-aged people with T2DM. Poor physical function and frailty is independently associated with increased risk of hospitalisation, disability and morbidity. Exercise is highly effective at counteracting decline in physical functioning related to T2DM. Exercise has multidimensional benefits for patients with T2DM including reduced risk of chronic diseases, such as cardiovascular diseases, increased life-expectancy and quality of life. While frailty is considered as a predictor of future disability, it might be modifiable, particularly at early stages of functional decline. Nevertheless there is a significant lack of intervention studies aimed to reduce functional decline in patients with T2DM. Therefore, this study aims to investigate the effect of a multi-modal exercise intervention on people with T2DM and impaired physical function. We aim to recruit adults with T2DM, aged between 40 and 70 years with low physical function. Participants will be randomised to either the exercise group or the control group with no exercise intervention. Participants in the exercise group will attend two supervised exercise sessions per week in Leicester Diabetes Centre for eight weeks. Each session will last up to 60 minutes and incorporate resistance exercise and moderate-intensity aerobic exercise together with balance and stretching exercises. Alongside the two weekly supervised exercise sessions, participants will be prescribed an additional home-based exercise session. These sessions will be tailored to the needs of the individual and ability to perform the exercise.

    Summary of Results

    This intervention was a single group trial involving individuals with or at risk of type 2 diabetes with physical function impairment. Participants were instructed to follow home-based exercise program for 8 weeks with remote supervision from an exercise physiologist. Co-primary outcomes of the study were the Incremental Shuttle Walk Test (ISWT) and Sit to Stand-60 test (STS-60). A sample of 18 participants has completed the study. Multi-modal exercise intervention resulted in significant improvements in ISWT by a mean of 37.2 meters (p=0.01) and STS-60 by 1.5 repetitions (p=0.01) and virtual STS-60 by 3.2 following the 8-week exercise intervention. While lower body strength has improved significantly, handgrip strength remained similar. Out of 25 enrolled participants, 18 participants completed the study (72% retention rate). There were no adverse intervention-related outcomes reported during the study. Despite some concerns of being unable to undertake resistance training at home, patients were able to perform strength exercises safely with heart rate monitoring and supervised guidance.

  • REC name

    South Central - Berkshire B Research Ethics Committee

  • REC reference

    19/SC/0418

  • Date of REC Opinion

    5 Sep 2019

  • REC opinion

    Favourable Opinion