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 (CARE training)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Other: Dietary energy restriction and exercise group (D+E); Other: Dietary energy restriction group (D)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 21
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chatwalai Sonthikul, Master degree; Phone Number: +447787548735; Email: cs2976@bath.ac.uk

Study Locations

• United Kingdom
  • England
    • Bath, England, United Kingdom, BA2 7AY
      • University of Bath
      • Contact: James Bilzon, PhD; Email: jb438@bath.ac.uk
      • Contact: Jennifer Maher, PhD; Email: jilm92@bath.ac.uk
      • Principal Investigator: Chatwalai Sonthikul, Master degree

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

The inclusion criteria for participation in this study are that patients have a chronic SCI that occurred at least one year before, an age range between 18 and 65 years, and sufficient upper limb function to engage in the exercise intervention. Participants must self-report that they use a wheelchair for the majority of their waking hours, namely 75% of their day, and have continually maintained a stable weight within a range of ± 3 kg over the duration of the previous three months.

Exclusion Criteria:

The study will exclude participants who have provided information about their medical conditions, such as unresolved pressure sores, urinary tract infections, active medical conditions that may be a contraindication to exercise testing (ACSM Exercise Testing Guidelines), or current musculoskeletal symptoms of the upper extremities. Individuals who have self-reported the use of medication for type 2 diabetes or pharmaceuticals that influence glucose metabolism will be excluded from involvement in the research.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary energy restriction and exercise group (D+E)	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.
Active Comparator: Dietary energy restriction group (D)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid profile	Blood sample	8 weeks
Fasting insulin concentration	Serum insulin concentration	8 weeks
Insulin sensitivity	Serum insulin concentration	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting matabolic rate	Measured using indirect calorimetry	8 weeks
Body mass	Measured using electronic wheelchair scales	8 weeks
Waist and hip circumference	Measured using a non-metallic tape	8 weeks
Height	Measured using a non-metallic tape	8 weeks
Total body fat percentage	Measured using duel-energy x-ray absorptiometry	8 weeks
Total Fat-Free Mass	Measured using duel-energy x-ray absorptiometry	8 weeks
Visceral Adipose Tissue	Measured using duel-energy x-ray absorptiometry	8 weeks
Total Fat Mass	Measured using duel-energy x-ray absorptiometry	8 weeks
Muscle, adipose and bone cross-sectional areas around the tibia and femur	Measured using Peripheral quantitative computed tomography	8 weeks
Bone geometry and tissue densities around the tibia and femur	Measured using peripheral quantitative computed tomography	8 weeks
adipose tissue	Measured using adipose tissue biopsy	8 weeks
Upper extremity muscle strength	Handheld dynamometer	8 weeks
Balance	The Modified Functional Reach Test	8 weeks
Health-related quality of life	Measured using a validated questionnaire	8 weeks
Shoulder Pain	Measured using a validated questionnaire	8 weeks
Energy intake and dietary macronutrient composition	Estimated using a 5-day weighed food diary	8 weeks
Energy expended in different physical activity intensities (MET categories) (kJ or kcal)	Energy expended in different physical activity intensities across 5-days (MET categories) (kJ or kcal)	8 weeks

Collaborators and Investigators

• Sponsor: University of Bath

Study record dates

Study Major Dates

• Study Start (Estimated): May 22, 2024
• Primary Completion (Estimated): February 22, 2025
• Study Completion (Estimated): May 22, 2025

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: high intensity interval training; resistance training; Chronic spinal cord injury; combined aerobic and resistance exercise training programme; cardiometabolic outcomes
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 12345678280233; UBath (Registry Identifier: Chatwalai)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No