Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06296771
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-29
Brief 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
Sponsor:
University of Bath
Organization:
University of Bath
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARE training
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 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 21 allocation ratio The participants will be assigned to either the dietary energy restriction and exercise group DE 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
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 21 allocation ratio The participants will be assigned to either the dietary energy restriction and exercise group DE 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 ampgt48 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 gt10 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 amp39needle aspirationamp39 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 21 to a dietary energy restriction with exercised DE 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 participantsamp39 energy expenditure as measured by ActiheartTM The individuals within the DE group will be instructed to reduce their habitual energy intake by 5000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UBath | REGISTRY | Chatwalai | None |