The effect of exercise on fasting insulin and fitness levels in people with spinal cord injury: Development of evidence-based exercise programs
| ISRCTN | ISRCTN15824294 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15824294 |
| Protocol serial number | 1040917-201404-HRBR-152-03 |
| Sponsor | Yonsei University |
| Funder | National Rehabilitation Research Institute |
- Submission date
- 24/05/2017
- Registration date
- 31/05/2017
- Last edited
- 30/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Individuals with spinal cord injury generally have a sedentary (inactive) lifestyle, which negatively impacts their fitness level and quality of life. Moreover, those with SCI are at increased risk of developing long-term health conditions such as type 2 diabetes, heart disease and metabolic syndrome (a group of conditions which increase a person's risk of heart attack or stroke). Therefore, promoting an active lifestyle for those with SCI is important for the prevention of these diseases. The aim of this study are to assess the effects of personalized exercise programs on insulin (the hormone which converts sugar in the blood into stored sugars) and fitness levels of people with spinal cord injury.
Who can participate?
Patients with Spinal cord injury
What does the study involve?
Patients are randomly allocated to either the exercise group or the control group. Those in the exercise group receive a six-week combined exercise program. Participants will exercise for 60 minutes per session, three times per week for six weeks. The daily exercise programs consist of a 25-minute warm up consisting of 5 min of joint exercises, 15 min of exercise on an arm ergometer, and 5 min of stretching, followed by a 30-minute exercise program (resistance, circuit, and aerobic training), and a 5-minute cool down (stretching). Those in the control group are instructed to continue with their usual daily activities. At the start of the study and after six weeks, participants in both groups provide blood samples to assess their insulin and blood sugar levels, and complete questionnaires about their quality of life and mood. In addition. participants have their fitness levels assessed.
What are the possible benefits and risks or participating?
Participants allocated to the exercise group will receive the thera-band, and results of clinical tests. There are no known risks to participants.
Where is the study run from?
Fitness Center, Yonsei University (South Korea)
When is the study starting and how long is it expected to run for?
April 2014 to December 2014
Who is funding the study?
National Rehabilitation Research Institute (South Korea)
Who is the main contact?
1. Professor Justin Jeon (scientific)
2. Dr Dong-Il Kim (public)
Contact information
Scientific
Yonsei University
134 Shinchon-Dong
Seodaemun-Gu
Seoul
120-749
Korea, South
Scientific
Yonsei University
Department of Sport and Leisure Studies
50 Yonsei-Ro, Seodaemun-Gu
Seoul
120-749
Korea, South
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomized controlled trial of six-weeks combined exercise program on fasting insulin and fitness levels in individuals with spinal cord injury |
| Study objectives | A six-week combined exercise program will improve on fasting insulin and fitness levels in individuals with spinal cord injury. |
| Ethics approval(s) | Institutional Ethics Review Board at Yonsei University College of Medicine, 04/04/2014, ref: 1040917-201404-HRBR-152-03 |
| Health condition(s) or problem(s) studied | Spinal cord injury |
| Intervention | Participants will be randomized to one of two groups using the minimization method. Intervention group: Participants will receive a 6-week combined exercise program. Participants will exercise for 60 minutes per session, three times per week for six weeks. The daily exercise programs consist of a 25-minute warm up consisting of 5 min of joint exercises, 15 min of exercise on an arm ergometer, and 5 min of stretching, followed by a 30-minute exercise program (resistance, circuit, and aerobic training), and a 5-minute cool down (stretching). Control group: Participants will be instructed to continue with their usual daily activities. Participants in both groups will be followed up after six weeks. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Fasting glucose is measured using ADVIA 1650 Chemistry System at baseline and six weeks |
| Key secondary outcome measure(s) |
1. Total cholesterol (TC), triglyceride (TG), high density lipoprotein cholesterol (HDL-C), and low density lipoprotein cholesterol (LDL-C) levels will be measured using an ADVIA 1650 Chemistry System at baseline and six weeks |
| Completion date | 22/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 18 |
| Key inclusion criteria | 1. An SCI >6 months 2. Age between 18 and 65 years 3. No regular exercise over the prior six months |
| Key exclusion criteria | 1. Cardiovascular disease 2. Uncontrolled type 2 diabetes 3. Uncontrolled hypertension 4. Pressure ulcers 5. Orthopedic problems |
| Date of first enrolment | 04/04/2014 |
| Date of final enrolment | 01/09/2014 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Seodaemun-Gu
Seoul
120-749
Korea, South
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from hiop1@hanmail.net |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
