The Effect of a Combined Aerobic and Resistance Exercise (CARE) Training Programme on Cardiometabolic Outcomes in Individuals With Chronic Spinal Cord Injury: A Randomised Controlled Trial

Alternative or complimentary methods
General health
Online since 3 April 2024, updated 6 days ago

About this trial

The goal of this study is to investigate the effectiveness of an 8-week dietary energy restriction with exercise or dietary energy restriction alone on the cardiometabolic health outcomes of individua...

Included participants

Gender
All
Age
18 - 65 years
Injury level
C1 - S5
  • Severity (AIS)?
  • Time since injury
    All
    Healthy volunteers
    No
    C1-S5

    What’s involved

    Type

    Alternative or complimentary methods

    Details

    This study is a randomised controlled trial conducted at a single centre, consisting of two parallel arms. The recruitment of 21 people with a chronic spinal cord injury will begin through the distribution of advertisements across several channels, including national disability charity websites, internet forums, and social media networking sites. Interested potential participants will be asked to contact the principal researcher for further information via email or telephone correspondence. The principal researcher will email a participant information sheet and health screening questionnaire and conduct a follow-up phone call >48 hours after the participant expresses their initial interest to fully explain what the trial entails and answer any questions. If the potential participant indicates that they wish to take part in the study, the first visit will be scheduled. On the first visit, participants will be asked to provide written informed consent. The study will involve a total of 2 assessment visits (~5 hours each), which will take place before and after an 8-week intervention. For these visits, participants will be asked to arrive after an overnight fast (>10 hours). During these visits, we will first assess anthropometrics by dual-energy X-ray absorptiometry and peripheral quantitative computed tomography. A principal researcher will adipose tissue biopsy by procedure known as 'needle aspiration' and insert a cannula into a vein in the forearm to allow regular blood samples to be taken for 2 hours following the oral consumption of glucose drinks. During the 2-hour glucose test, participants will be asked to complete two questionnaires on pain, and quality of life. Participants will then be given lunch and asked to perform a maximal exercise test on an arm-crank ergometer, muscular strength by hand-held dynamometer, and balance by functional reach test. Participants will be asked to wear a physical activity monitor for 5 days following the initial visit and in the final week of the 8-week period. Participants will also be asked to complete a questionnaire about the satisfaction and perceived benefits of the programme intervention on week 8. After baseline testing, eligible consenting participants will be randomly allocated (2:1) to a dietary energy restriction with exercised (D+E) or dietary energy restriction alone (D) using a sealed envelope and balance groups for key characteristics (age, sex, and and level of injury) at baseline. The participants allocated to the D group will receive instructions to reduce meal portions for a total calorie deficit of 5000 kcal per week and maintain their regular physical activity routine for the duration of eight weeks. This deficit is computed by subtracting the participants' energy expenditure, as measured by ActiheartTM. The individuals within the D+E group will be instructed to reduce their habitual energy intake by 5,000 kcal per week while taking part in physical exercise with a frequency of three sessions per week of HIIT and two sessions per week of resistance exercise throughout a duration of 8 weeks. Throughout the exercise training sessions, participants will receive instructions to employ a chest-worn heart rate (HR) monitor.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    Bone health

    Mental health

    Pain

    Standing/walking/mobility

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 22 May 2024
    • Organisation
    • University of Bath
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 22 May 2024
    • Organisation
    • University of Bath

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more