Condition category
Nervous System Diseases
Date applied
24/05/2017
Date assigned
31/05/2017
Last edited
30/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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)

Trial website

Contact information

Type

Scientific

Primary contact

Prof Justin Y Jeon

ORCID ID

Contact details

Yonsei University
134 Shinchon-Dong
Seodaemun-Gu
Seoul
120-749
Korea
South

Type

Scientific

Additional contact

Dr Dong-Il Kim

ORCID ID

Contact details

Yonsei University
Department of Sport and Leisure Studies
50 Yonsei-Ro
Seodaemun-Gu
Seoul
120-749
Korea
South

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1040917-201404-HRBR-152-03

Study information

Scientific title

A randomized controlled trial of six-weeks combined exercise program on fasting insulin and fitness levels in individuals with spinal cord injury

Acronym

Study hypothesis

A six-week combined exercise program will improve on fasting insulin and fitness levels in individuals with spinal cord injury.

Ethics approval

Institutional Ethics Review Board at Yonsei University College of Medicine, 04/04/2014, ref: 1040917-201404-HRBR-152-03

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

No participant information sheet available

Condition

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

Phase

Drug names

Primary outcome measures

1. Fasting glucose is measured using ADVIA 1650 Chemistry System at baseline and six weeks
2. Insulin is measured using Roche Chemistry System at baseline and six weeks
3. Insulin resistance will be estimated according to the homeostasis model assessment of insulin resistance (HOMA-IR) index at baseline and six weeks

Secondary outcome measures

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
2. Upper body strengh will be measured by a hand-held dynamometer at baseline and six weeks
3. Vo2 peak will be assessed through maximal graded exercise tests, performed using a ramp protocol at baseline and six weeks.
4. Quality of life will be measured using the SF-36 questionnaire at baseline and six weeks
5. Anxiety and depression will be measured using the Generalized Anxiety Disorder 7-item (GAD-7) scale and Patient Health Questionnaire (PHQ-9) at baseline and six weeks

Overall trial start date

01/02/2014

Overall trial end date

22/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. An SCI >6 months
2. Age between 18 and 65 years
3. No regular exercise over the prior six months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

18 individuals with SCI (exercise group: 12, control group: 6)

Participant exclusion criteria

1. Cardiovascular disease
2. Uncontrolled type 2 diabetes
3. Uncontrolled hypertension
4. Pressure ulcers
5. Orthopedic problems

Recruitment start date

04/04/2014

Recruitment end date

01/09/2014

Locations

Countries of recruitment

Korea, South

Trial participating centre

Yonsei University College of Medicine
134 Shinchon-Dong Seodaemun-Gu
Seoul
120-749
Korea, South

Sponsor information

Organisation

Yonsei University

Sponsor details

Department of sport industry studies
134 Shinchon-DongSeodaemun-Gu
Seoul
120-749
Korea
South

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

National Rehabilitation Research Institute

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

IPD Sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from hiop1@hanmail.net

Intention to publish date

31/12/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes