Spinal Cord InjuryCARE trainingNCT06296771
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
A study testing Dietary energy restriction group (D) and Dietary energy restriction and exercise group (D+E) in people with Spinal Cord Injury, run by University of Bath at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Dietary energy restriction group (D) and Dietary energy restriction and exercise group (D+E)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 May 2024to 22 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Bath
Bath, England, BA2 7AY
James Bilzon, PhD, jb438@bath.ac.uk
Jennifer Maher, PhD, jilm92@bath.ac.uk
About this study
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:
- 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
- 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.
Read the 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Dietary energy restriction group (D), Dietary energy restriction and exercise group (D+E)
- Keywords
- Chronic spinal cord injury, combined aerobic and resistance exercise training programme, cardiometabolic outcomes, high intensity interval training, resistance training
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Dietary energy restriction and exercise group (D+E) | Experimental | Not described Receives: Other: Dietary energy restriction and exercise group (D+E) |
| Dietary energy restriction group (D) | Active comparator | Not described Receives: Other: Dietary energy restriction group (D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile
Blood sample
Measured: 8 weeks
Fasting insulin concentration
Serum insulin concentration
Measured: 8 weeks
Insulin sensitivity
Serum insulin concentration
Measured: 8 weeks
Secondary outcomes (17)
Resting matabolic rate
Measured using indirect calorimetry
Measured: 8 weeks
Body mass
Measured using electronic wheelchair scales
Measured: 8 weeks
Waist and hip circumference
Measured using a non-metallic tape
Measured: 8 weeks
Height
Measured using a non-metallic tape
Measured: 8 weeks
Total body fat percentage
Measured using duel-energy x-ray absorptiometry
Measured: 8 weeks
Total Fat-Free Mass
Measured using duel-energy x-ray absorptiometry
Measured: 8 weeks
Visceral Adipose Tissue
Measured using duel-energy x-ray absorptiometry
Measured: 8 weeks
Total Fat Mass
Measured using duel-energy x-ray absorptiometry
Measured: 8 weeks
Muscle, adipose and bone cross-sectional areas around the tibia and femur
Measured using Peripheral quantitative computed tomography
Measured: 8 weeks
Bone geometry and tissue densities around the tibia and femur
Measured using peripheral quantitative computed tomography
Measured: 8 weeks
adipose tissue
Measured using adipose tissue biopsy
Measured: 8 weeks
Upper extremity muscle strength
Handheld dynamometer
Measured: 8 weeks
Balance
The Modified Functional Reach Test
Measured: 8 weeks
Health-related quality of life
Measured using a validated questionnaire
Measured: 8 weeks
Shoulder Pain
Measured using a validated questionnaire
Measured: 8 weeks
Energy intake and dietary macronutrient composition
Estimated using a 5-day weighed food diary
Measured: 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)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start22 May 2024 (estimated)
- Primary completion22 Feb 2025 (estimated)
- Study completion22 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chatwalai Sonthikul, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296771
- Sponsor's protocol ID
- 12345678280233
- Other IDs
- UBath
- Acronym
- CARE training
- Status last verified
- Feb 2024
- First submitted
- 29 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06296771
- Acronym / sponsor ID
- CARE training / 12345678280233
- Conditions
- Spinal Cord Injury
- Keywords
- Chronic spinal cord injury, combined aerobic and resistance exercise training programme, cardiometabolic outcomes, high intensity interval training, resistance training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 22 May 2024 (estimated)
- Primary completion
- 22 Feb 2025 (estimated)
- Study completion
- 22 May 2025 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 group (D) |
| 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. | Other | Dietary energy restriction and exercise group (D+E) |
Primary outcome
Lipid profile
Time frame: 8 weeks
Blood sample
Fasting insulin concentration
Time frame: 8 weeks
Serum insulin concentration
Insulin sensitivity
Time frame: 8 weeks
Serum insulin concentration
17 secondary outcomes
Resting matabolic rate
Time frame: 8 weeks
Body mass
Time frame: 8 weeks
Waist and hip circumference
Time frame: 8 weeks
Height
Time frame: 8 weeks
Total body fat percentage
Time frame: 8 weeks
Total Fat-Free Mass
Time frame: 8 weeks
Visceral Adipose Tissue
Time frame: 8 weeks
Total Fat Mass
Time frame: 8 weeks
Muscle, adipose and bone cross-sectional areas around the tibia and femur
Time frame: 8 weeks
Bone geometry and tissue densities around the tibia and femur
Time frame: 8 weeks
adipose tissue
Time frame: 8 weeks
Upper extremity muscle strength
Time frame: 8 weeks
Balance
Time frame: 8 weeks
Health-related quality of life
Time frame: 8 weeks
Shoulder Pain
Time frame: 8 weeks
Energy intake and dietary macronutrient composition
Time frame: 8 weeks
Energy expended in different physical activity intensities (MET categories) (kJ or kcal)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary energy restriction group (D) and Dietary energy restriction and exercise group (D+E) in people with Spinal Cord Injury, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chatwalai Sonthikul, Master degree (+447787548735, cs2976@bath.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid profile (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.