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)

February 29, 2024 updated by: Chatwalai Sonthikul, University of Bath

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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:
        • Contact:
        • Principal Investigator:
          • Chatwalai Sonthikul, Master degree

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lipid profile
Time Frame: 8 weeks
Blood sample
8 weeks
Fasting insulin concentration
Time Frame: 8 weeks
Serum insulin concentration
8 weeks
Insulin sensitivity
Time Frame: 8 weeks
Serum insulin concentration
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Resting matabolic rate
Time Frame: 8 weeks
Measured using indirect calorimetry
8 weeks
Body mass
Time Frame: 8 weeks
Measured using electronic wheelchair scales
8 weeks
Waist and hip circumference
Time Frame: 8 weeks
Measured using a non-metallic tape
8 weeks
Height
Time Frame: 8 weeks
Measured using a non-metallic tape
8 weeks
Total body fat percentage
Time Frame: 8 weeks
Measured using duel-energy x-ray absorptiometry
8 weeks
Total Fat-Free Mass
Time Frame: 8 weeks
Measured using duel-energy x-ray absorptiometry
8 weeks
Visceral Adipose Tissue
Time Frame: 8 weeks
Measured using duel-energy x-ray absorptiometry
8 weeks
Total Fat Mass
Time Frame: 8 weeks
Measured using duel-energy x-ray absorptiometry
8 weeks
Muscle, adipose and bone cross-sectional areas around the tibia and femur
Time Frame: 8 weeks
Measured using Peripheral quantitative computed tomography
8 weeks
Bone geometry and tissue densities around the tibia and femur
Time Frame: 8 weeks
Measured using peripheral quantitative computed tomography
8 weeks
adipose tissue
Time Frame: 8 weeks
Measured using adipose tissue biopsy
8 weeks
Upper extremity muscle strength
Time Frame: 8 weeks
Handheld dynamometer
8 weeks
Balance
Time Frame: 8 weeks
The Modified Functional Reach Test
8 weeks
Health-related quality of life
Time Frame: 8 weeks
Measured using a validated questionnaire
8 weeks
Shoulder Pain
Time Frame: 8 weeks
Measured using a validated questionnaire
8 weeks
Energy intake and dietary macronutrient composition
Time Frame: 8 weeks
Estimated using a 5-day weighed food diary
8 weeks
Energy expended in different physical activity intensities (MET categories) (kJ or kcal)
Time Frame: 8 weeks
Energy expended in different physical activity intensities across 5-days (MET categories) (kJ or kcal)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bath

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 22, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 22, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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