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

NCT06296771 | Not Yet Recruiting

• 2 other identifiers: 12345678280233UBath
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.the effectiveness of an 8-week dietary energy restriction with exercise or dietary energy restriction alone on fitness and health outcomes.

Conditions

Spinal Cord Injury

Keywords

Chronic spinal cord injury; combined aerobic and resistance exercise training programme; cardiometabolic outcomes; high intensity interval training; resistance training

Outcome Measures

Primary Outcomes (3)

• Lipid profile

  Blood sample

  8 weeks

• Fasting insulin concentration

  Serum insulin concentration

  8 weeks

• Insulin sensitivity

  Serum insulin concentration

  8 weeks

Secondary Outcomes (17)

• Resting matabolic rate

  8 weeks

• Body mass

  8 weeks

• Waist and hip circumference

  8 weeks

• Height

  8 weeks

• Total body fat percentage

  8 weeks

Study Arms (2)

Dietary energy restriction and exercise group (D+E)

EXPERIMENTAL

Other: Dietary energy restriction and exercise group (D+E)

Dietary energy restriction group (D)

ACTIVE COMPARATOR

Other: Dietary energy restriction group (D)

Interventions

Dietary energy restriction group (D) OTHER

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.

Dietary energy restriction group (D)

Dietary energy restriction and exercise group (D+E) OTHER

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.

Dietary energy restriction and exercise group (D+E)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bath: lead

Study Sites (1)

University of Bath

Bath, England, BA2 7AY, United Kingdom

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Fumigant 93

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Chatwalai Sonthikul, Master degree

CONTACT

+447787548735; cs2976@bath.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 6, 2024
• Study Start: May 22, 2024
• Primary Completion: February 22, 2025
• Study Completion: May 22, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-02

Locations

GB (1)