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

Summary

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 individuals with chronic spinal cord injury. This study is a randomised controlled trial conducted at a single centre, consisting of two parallel arms. The main questions it aims to answer are:

1. the effectiveness of an 8-week dietary energy restriction with exercise or dietary energy restriction alone on cardiometabolic disease biomarker outcomes in individuals with chronic SCI
2. the effectiveness of an 8-week dietary energy restriction with exercise or dietary energy restriction alone on fitness and health outcomes.

Twenty-one participants will be randomly assigned in a 2:1 allocation ratio. The participants will be assigned to either the dietary energy restriction and exercise group (D+E) group, which combines dietary energy restriction and exercise intervention, or the dietary energy restriction group (D) group, which just undergoes dietary energy restriction using sealed envelopes.

Conditions

• Spinal Cord Injury

Interventions

OTHER

Dietary energy restriction group (D)

The participants allocated to the dietary energy restriction group will receive instructions to change their usual dietary intake and maintain their regular physical activity routine for the duration of eight weeks. The dietary energy restriction depends on a total calorie deficit of 5000 kcal per week, achieved by the consumption of reduced meal portions. This deficit is computed by subtracting the participants\' energy expenditure, as measured by ActiheartTM, rather than relying on reported energy intake. This approach is employed to reduce potential difficulties arising from participants under-reporting their food consumption. The energy deficit is calculated by multiplying the weight of each food item recorded over a 5-day period by an individual factor obtained from energy expenditure data. This calculation enables the determination of the required energy intake for the intervention period.

OTHER

Dietary energy restriction and exercise group (D+E)

The individuals within the dietary energy restriction and exercise 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. Sessions can be performed in any order, but we will recommend alternating HIIT and resistance training days and taking the two rest days separately to allow for recovery. The exercise programme will start the session by participating in a gentle stretching routine with the objective of reducing the effects of exercise-induced shoulder discomfort. The treatment focuses on the four main muscle groups in the upper body: the latissimus dorsi, the triceps, the rhomboid, the pectoral, and the upper trapezius. Each pose is held in the stretched position for a length of 15 seconds throughout each set, for a total of 4 sets.

Sponsors & Collaborators

• University of Bath

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-22

Primary Completion

2025-02-22

Completion

2025-05-22

Countries

• United Kingdom

Study Locations