protocolSection identificationModule nctId: NCT06296771, orgStudyIdInfo id: 12345678280233, secondaryIdInfos id: UBath, type: REGISTRY, domain: Chatwalai, briefTitle: 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, acronym: CARE training, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-22, primaryCompletionDateStruct date: 2025-02-22, completionDateStruct date: 2025-05-22, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Bath, class: OTHER, descriptionModule briefSummary: 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 SCI2. 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., conditionsModule conditions: Spinal Cord Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 21, type: ESTIMATED, armsInterventionsModule interventions name: Dietary energy restriction group (D), interventions name: Dietary energy restriction and exercise group (D+E), outcomesModule primaryOutcomes measure: Lipid profile, primaryOutcomes measure: Fasting insulin concentration, primaryOutcomes measure: Insulin sensitivity, secondaryOutcomes measure: Resting matabolic rate, secondaryOutcomes measure: Body mass, secondaryOutcomes measure: Waist and hip circumference, secondaryOutcomes measure: Height, secondaryOutcomes measure: Total body fat percentage, secondaryOutcomes measure: Total Fat-Free Mass, secondaryOutcomes measure: Visceral Adipose Tissue, secondaryOutcomes measure: Total Fat Mass, secondaryOutcomes measure: Muscle, adipose and bone cross-sectional areas around the tibia and femur, secondaryOutcomes measure: Bone geometry and tissue densities around the tibia and femur, secondaryOutcomes measure: adipose tissue, secondaryOutcomes measure: Upper extremity muscle strength, secondaryOutcomes measure: Balance, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Shoulder Pain, secondaryOutcomes measure: Energy intake and dietary macronutrient composition, secondaryOutcomes measure: Energy expended in different physical activity intensities (MET categories) (kJ or kcal), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Bath, city: Bath, state: England, zip: BA2 7AY, country: United Kingdom, contacts name: James Bilzon, PhD, role: CONTACT, email: jb438@bath.ac.uk, contacts name: Jennifer Maher, PhD, role: CONTACT, email: jilm92@bath.ac.uk, contacts name: Chatwalai Sonthikul, Master degree, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.3751, lon: -2.36172, hasResults: False