The Spinal Cord Injury Move More (SCIMM) study: benefits of breaking up prolonged sedentary time on heart disease risk in people with spinal cord injury
| ISRCTN | ISRCTN51868437 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51868437 |
| IRAS number | 220036 |
| Secondary identifying numbers | 1, IRAS 220036 |
- Submission date
- 01/02/2017
- Registration date
- 01/02/2017
- Last edited
- 30/04/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Prolonged periods of time spent inactive and sitting (sedentary) increases the risk of heart disease even if the person is active at other times. This means that even people who meet the government guidelines of 150 minutes of moderate physical activity per week may have a higher risk of heart disease if they spend long periods being sedentary (sitting). Heart disease is the leading cause of death in people with spinal cord injury which may be because they are highly sedentary. The aim of this study is to find out whether breaking up prolonged sedentary time lowers the heart disease risk of inactive people with spinal cord injury.
Who can participate?
Men and women aged 18-60 with a spinal cord injury below T6
What does the study involve?
Participants are weighed and they undergo a dual energy x-ray absorptiometry (DXA) scan. This scan shows their bone density, fat mass and fat-free mass (bone and muscle) levels. Participants then take part in two different activities that each last 5.5 hours, with a break of at least 6 days between each activity. The two activities are (1) uninterrupted sitting, where participants remain seated at a desk for the 5.5 hour day and (2) sitting plus activity breaks, where participants carry out 2-minute bouts of moderate-intensity exercise every 20 minutes over the 5.5 hour day. During the inactive periods the participants carry out desk-based activities on a computer, read, talk, or watch DVDs. Participants’ markers of heart disease risk are measured before and during the study, including levels of blood sugar and cholesterol after eating, insulin levels and blood pressure.
What are the possible benefits and risks of participating?
Breaking up prolonged sedentary time with regular short activity breaks may be an effective way to lower the risk of heart disease in people with spinal cord injury and a simple strategy that they are more likely to take part in. In the long term, the results will help to inform new physical activity and clinical care guidelines to reduce the risk of heart disease in people with a sedentary lifestyle including those with spinal cord injury. The benefit of having a DXA scan is that if participants are found to have low bone density they can consult their doctor about ways of reducing their risk of breaking a bone at a later date. Participants also receive information on their body fat levels from this scan. The risks of physical activity include: heart/muscle/bone damage, breathing problems, sickness, fainting, dehydration and overheating. Risks are minimised by asking participants to complete a health questionnaire before the activity and only allowing people who are healthy to complete exercise that is appropriate to them. These risks are very rare in healthy people. Participants may stop the test at any time. If any of the above symptoms occur, they are asked to stop the test and monitored for a reasonable time. There is a very small risk of contamination from blood sample collection and from using facemasks. However, these risks are minimised by using protective equipment, disinfecting all re-usable equipment and screening all participants with health questionnaires before they take part in the study. People with any blood borne disease or virus are not permitted to take part in the study. Only trained researchers take the blood samples and they adhere to guidelines to reduce the risk of cross-infection, which is very rare. As a part of this study participants are exposed to a very small amount of X-rays during their DXA scan(s). X-rays can cause harmful effects such as the development of cancer, but the amount used in this study is very, very tiny and there is a similar risk from less than 2 days of natural background radiation in the UK.
Where is the study run from?
University of Bedfordshire (UK)
When is the study starting and how long is it expected to run for?
November 2016 to February 2019
Who is funding the study?
Heart Research UK
Who is the main contact?
Dr Daniel Bailey
daniel.bailey@beds.ac.uk
Contact information
Scientific
Centre for Human Performance, Exercise and Rehabilitation
Sport, Health and Exercise Sciences
CHLS - Life Sciences
Brunel University London
Uxbridge
London
UB8 3PH
United Kingdom
 ORCID ID |
0000-0003-3772-630X |
|---|---|
| Phone | +44 (0)1895 265363 |
| daniel.bailey@brunel.ac.uk |
Study information
| Study design | Randomised two-condition cross over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | ISRCTN51868437_PIS_01Feb17.docx |
| Scientific title | The Spinal Cord Injury Move More (SCIMM) study: benefits of breaking up prolonged sedentary time on cardiovascular disease risk markers in people with spinal cord injury |
| Study acronym | SCIMM |
| Study objectives | Current hypothesis as of 10/11/2017: It is hypothesised that breaking up prolonged sedentary time will result in improved cardiovascular disease risk marker responses compared with prolonged uninterrupted sedentary time in people with spinal cord injury. Previous hypothesis: It is hypothesised that breaking up prolonged sedentary time will result in similar cardiovascular disease risk marker responses to a continuous energy-matched exercise session and that both of these conditions will result in more favourable risk marker responses than prolonged uninterrupted sedentary time in people with spinal cord injury. |
| Ethics approval(s) | Cambridge South NHS Research Ethics Committee, 13/05/2017, ref: 17/EE/0076 |
| Health condition(s) or problem(s) studied | Spinal cord injury |
| Intervention | Current interventions as of 10/11/2017: This is a randomised crossover design with two trial conditions that each last 5.5 hours with a minimum washout of at least 6 days between each condition. The study will test the heart disease risk marker responses to the two conditions below. A researcher who is not involved in participant recruitment and intervention will create a randomization list using the block randomization method (software: Research Randomizer, https://www.randomizer.org). This list will be provided to the study investigators. The investigator responsible for enrolment will remain blinded to the intervention allocations until 48 hours prior to the first main trial for each participant. The trial conditions are: 1. Uninterrupted sitting (SIT): participants will remain seated uninterrupted at a desk during the 5.5 hour trial period 2. Sitting + activity breaks (SIT-ACT): participants will perform 2 min of moderate-intensity arm crank exercise every 20 min during the 5.5 hour day with the first bout taking place 20 min after breakfast. The moderate-intensity exercise in the SIT-ACT condition will be performed at a Rating of Perceived Exertion of 13 (somewhat hard). During the inactive periods the volunteers will carry out desk-based activities on a computer, read, talk, or watch DVDs. Before and during the trial, the researchers will measure each participant’s levels of blood sugar and cholesterol after eating, insulin levels and blood pressure. There is no follow-up. Previous interventions: This is a randomised crossover design with three trial conditions that each last 7 hours with a minimum washout of at least 6 days between each condition. The study will test the heart disease risk marker responses to the three conditions below. A researcher who is not involved in participant recruitment and intervention will create a randomization list using the block randomization method (software: Research Randomizer, https://www.randomizer.org). This list will be provided to the study investigators. The investigator responsible for enrolment will remain blinded to the intervention allocations until 48 hours prior to the first main trial for each participant. The trial conditions are: 1. Uninterrupted sitting (SIT): participants will remain seated uninterrupted in their wheelchair at a desk during the 7 h trial period 2. Continuous physical activity (CONT): participants will perform a continuous 40 min bout of moderate-intensity arm crank exercise 20 min after consuming a standardised breakfast meal, which will be followed by uninterrupted sitting at a desk for the rest of the day 3. Sitting + activity breaks (SIT-ACT): participants will perform 2 min of moderate-intensity arm crank exercise every 20 min during the 7 h day with the first bout taking place 20 min after breakfast. These 20 breaks will equate to 40 min and will match energy expenditure of the CONT trial condition The moderate-intensity exercise in the CONT and SIT-ACT conditions will be performed at a power output corresponding to 40% VO2Reserve. During the inactive periods the volunteers will carry out desk-based activities on a computer, read, talk, or watch DVDs. Before and during the trial, the researchers will measure each participant’s levels of blood sugar and cholesterol after eating, insulin levels and blood pressure. There is no follow-up. |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measures as of 10/11/2017: Postprandial plasma glucose concentration incremental area under the curve, measured with a benchtop analyser from whole blood samples collected at baseline and then regularly during each of the two trial conditions Previous primary outcome measures: Postprandial plasma glucose concentration incremental area under the curve, measured spectrophotometrically from venous blood samples collected at baseline and then hourly during each of the three trial conditions |
| Secondary outcome measures | Current secondary outcome measures as of 10/11/2017: 1. Incremental area under the curve for postprandial triglycerides, measured with a benchtop analyser from whole blood samples collected at baseline and then regularly during each of the two trial conditions 2. Incremental area under the curve for HDL, with a benchtop analyser from plasma collected at baseline and then regularly during each of the two trial conditions 3. Incremental area under the curve for insulin, measured using an enzyme immunoassay from plasma samples collected at baseline and then regularly during each of the two trial conditions 4. Systolic and diastolic blood pressure, measured using an automated oscillatory blood pressure monitor at baseline and then regularly during each trial Previous secondary outcome measures: 1. Incremental area under the curve for postprandial triglycerides, measured spectrophotometrically from venous blood samples collected at baseline and then hourly during each of the three trial conditions 2. Incremental area under the curve for HDL, measured spectrophotometrically from venous blood samples collected at baseline and then hourly during each of the three trial conditions 3. Incremental area under the curve for insulin, measured using an enzyme immunoassay from venous blood samples collected at baseline and then hourly during each of the three trial conditions 4. Total area under the curve for IL-6, measured using an enzyme immunoassay from venous blood samples collected at baseline and then hourly during each of the three trial conditions 5. Systolic and diastolic blood pressure, measured using an automated oscillatory blood pressure monitor at baseline and then hourly during each trial |
| Overall study start date | 16/11/2016 |
| Completion date | 04/02/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Male |
| Target number of participants | 20 |
| Total final enrolment | 18 |
| Key inclusion criteria | Current inclusion criteria as of 10/11/2017: 1. Male and female 2. Aged 18-60 years 3. Not highly active: engaging in less than <300 min per week of moderate-to-vigorous physical activity 4. Have a chronic spinal cord injury (≥1 year since injury) 5. Injured at Thoracic level 6 to Sacral Level 5 (mild to low level paraplegia). These individuals have intact sympathetic innervation to the heart and resting blood pressure is typically normal Previous inclusion criteria: 1. Male 2. Aged 18-50 years 3. Physically inactive: engaging in less than <150 min per week of moderate-to-vigorous physical activity 4. Have a chronic spinal cord injury (≥1 year since injury) 5. Injured at Thoracic level 6 to Sacral Level 5 (mild to low level paraplegia). These individuals have intact sympathetic innervation to the heart and resting blood pressure is typically normal |
| Key exclusion criteria | Current exclusion criteria as of 10/11/2017: 1. Diagnosed diabetes, hypertension, hypotension, renal failure, liver disease, or history of severe cardiovascular complications 2. Body mass index >45 kg/m2 (severe obesity) 3. A history of autonomic dysreflexia 4. Taking glucose-lowering medication 5. Smoking 6. Major illness or other health issues that may limit ability to perform the exercise protocols Previous exclusion criteria: 1. Diagnosed diabetes, hypertension, hypotension, renal failure, liver disease, or history of severe cardiovascular complications 2. Body mass index >45 kg/m2 (severe obesity) 3. A history of autonomic dysreflexia 4. Taking glucose or lipid-lowering medication 5. Smoking 6. Major illness or other health issues that may limit ability to perform the exercise protocols |
| Date of first enrolment | 03/04/2017 |
| Date of final enrolment | 30/11/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Bedford
MK41 9EA
United Kingdom
Sponsor information
University/education
Polhill Avenue
Bedford
MK41 9EA
England
United Kingdom
"ROR" |
https://ror.org/0400avk24 |
|---|
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 04/02/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Daniel Bailey (daniel.bailey@beds.ac.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 01/02/2017 | 21/02/2017 | No | Yes | |
| Protocol article | protocol | 22/06/2018 | 24/10/2019 | Yes | No |
| Results article | results | 01/08/2020 | 30/04/2020 | Yes | No |
| HRA research summary | 26/07/2023 | No | No |
Additional files
- ISRCTN51868437_PIS_01Feb17.docx
- Uploaded 21/02/2017
Editorial Notes
30/04/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The trial website is no longer active and has been removed (http://heartresearch.org.uk/spending-money/exercise-and-people-spinal-cord-injury).
20/02/2020: The following changes have been made:
1. The IRAS number has been added.
2. The total final enrolment number has been added.
19/02/2020: The scientific contact has been updated.
24/10/2019: Publication reference added.
03/10/2018: The recruitment start date has been changed from 15/08/2018 to 30/11/2018.
10/11/2017: The following changes were made to the trial record:
1. The study design was changed from 'Randomised three-condition cross over study' to 'Randomised two-condition cross over study'.
2. The recruitment end date was changed from 30/07/2017 to 15/08/2018.
30/08/2017: Ethics approval has been added.
21/02/2017: Participant information sheet uploaded.
