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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02850133
Other study ID # 201007031R
Secondary ID
Status Completed
Phase N/A
First received July 1, 2016
Last updated July 27, 2016
Start date August 2010
Est. completion date July 2013

Study information

Verified date July 2016
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Ministry of Health and Welfare
Study type Interventional

Clinical Trial Summary

Background:

Patients with spinal cord injury (SCI) have a higher prevalence of cardiovascular diseases compared to the healthy population. Aerobic exercise training is one of the recommended treatments. However, literature regarding the effect of aerobic training on patients with SCI is scarce. This study evaluated changes in parameters of exercise physiology and serum myokines immediately after exercise and after a training program among patients with SCI.

Method:

Male patients with SCI and age- and sex-matched healthy individuals were recruited. Cardio-pulmonary exercise testing (CPET) was used to determine oxygen uptake at peak exercise and anaerobic threshold in both groups. The patients with SCI attended aerobic exercise training for 36 sessions within 12-16 weeks. Basic data, hemodynamic and exercise physiology parameters, and serum myokine (myostatin, insulin like growth factor, and follistatin) concentrations were measured pre- and post-exercise in both groups, and were repeated in patients with SCI post-training.


Description:

The patients with SCI were invited to undergo a 12- to 16-week exercise training by arm ergometry. The exercise physiology and measurements of hemodynamic parameters and cytokines were repeated after completion of the training.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years and older
Eligibility Inclusion Criteria:

- age >20 years, male sex, and onset of injury more than one year

Exclusion Criteria:

- known heart disease, atrial fibrillation/flutter, ventricular bigeminy, active inflammatory disease, malignancy, and cardiac pacemakers

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Other:
aerobic exercise training
aerobic exercise training for 36 sessions within 12-16 weeks

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
National Taiwan University Hospital National Science Council, Taiwan

Outcome

Type Measure Description Time frame Safety issue
Primary serum myokines 12-16 weeks No
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