Walk-Training Program for Individuals With Chronic Spinal Cord Injury (SCI)

Study Overview
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Brief Summary
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Cardiovascular disease (CVD) is the common leading cause of death among people with spinal cord injury (SCI) and occurs at an early age in people with SCI as compared to able-bodied people. The findings are consistent in demonstrating a high prevalence of CVD among people with SCI. Lack of physical activity and/or prolonged sitting which is observed in people with SCI due to impaired/loss of motor function is associated with increased risk factors of CVD. By doing this study, researchers hope to learn the effects of walking training on cardiovascular health among people with chronic SCI.

Official Title
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Benefits of a Walk-Training Program on Cardiovascular Health in Individuals With Chronic Spinal Cord Injury (SCI)

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Behavioral: walking training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals between 18 and 60 years old, who have paraplegia (T1-L2) SCI, and who are scored less than 5 in Functional Independence Measure, Locomotion: Walk The onset of SCI must be one year or more at the beginning of the study Participants must not be participating in any other similar gait training activities Participants must have medical approval from their physician to participate in walk-training Exclusion Criteria: Major Cardiovascular diseases Other neurological diseases Muscle spasticity (greater than 3 according to Ashworth scale) Severe orthopedic issues such as joint stiffness and fractures Osteoporosis (bone mineral density T-score less than - 2.5)[155] Inflammatory diseases or infections Open wound and pressure ulcer Pregnant women Cognitive or psychiatric disorders Uncontrolled autonomic dysreflexia; sudden increase in blood pressure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants will undergo a walking program using a treadmill, a body-weight support system, and an assistive device. | Behavioral: walking training<br>* Participants will receive three sessions a week of BWSTT with assistive training device for 8 weeks; a total of 24 sessions. The duration of each training session will an hour. During walk-training, the participant will wear a harness which is attached to an overhead motorized lift to provide body-weight support and to prevent the risk of falling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The recruitment feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI. | Recruitment rate will be assessed by recording the number of participants who are screened for eligibility, those who are excluded because of eligibility criteria, and those who decline to participate in the study. | From baseline to week 8 | 
| The perception feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI. | Information on perception will be acquired through a questionnaire that will be administered to participants at the end of walk-training program. | From baseline to week 8 | 
| The compliance feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI. | Data on compliance rate will be documented during a period of training. The total number of completed sessions and incomplete sessions along with reasons for absence will be recorded throughout the study. | From baseline to week 8 | 
| The retention feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI. | Data on retention will be obtained by recording the number of participants who drop out during the study along with their reasons. | From baseline to week 8 | 
| The walking performance (walking time) feasibility of an 8-week walk-training program in patients with chronic SCI. | The time of walking (minutes) that a participant will be able to walk on a treadmill during each training session will be recorded. | From baseline to week 8 | 
| The walking performance (treadmill walking speed) feasibility of an 8-week walk-training program in patients with chronic SCI. | The amount of treadmill speed (miles/hour) that a participant will be able to walk will be recorded during each training session. | From baseline to week 8 | 
| The walking performance (number of stepping) feasibility of an 8-week walk-training program in patients with chronic SCI. | The number of stepping during each training session will be recorded using a step tracker. | From baseline to week 8 | 
| Correlations between changes in four factors (muscle activity, cardiac autonomic function, spasticity, and lung capacity) and changes in heart rate after the walk-training program. | The resting heart rate will be measured during sitting position after 5 minutes rest. Exercise heart rate will be measured during a graded treadmill walking test with the same testing conditions pre- and post-training. The signal activity of four muscles in the lower limbs (biceps femoris, rectus femoris, gastrocnemius medialis, and tibialis anterior) will be measured using electromyography (EMG) system. The EMG recording will be obtained during walking on a treadmill. The average root-mean-square EMG for each muscle during gait cycle will be calculated. Cardiac autonomic function will be determined through power spectral of heart rate variability (HRV) using electrocardiography system. HRV frequency domain, including total power, low frequency (LF) and high frequency (HF) powers, and ratio of LF/HF, will be calculated and analyzed. Muscle spasticity for the lower extremities will be assessed through Modified Tardieu Scale. lung capacity will be measured through a spirometer. | Change from baseline to week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in lipid profile after 8-week walk-training program. | For lipid profile, we will assess serum concentrations of total cholesterol, low density lipoprotein and high density lipoprotein using an enzymatic colorimetric assay. | Change from baseline to week 8 | 
| Changes in the level of glycated hemoglobin (HbA1c) after 8-week walk-training program. | The level of HbA1c will be assessed using a device A1CNow+ System. | Change from baseline to week 8 | 
| Changes in the level of pro-inflammatory markers after 8-week walk-training program. | For inflammatory markers, serum concentrations of C-reactive protein and interleukin-6 will be determined using an enzyme-linked immunosorbent assay. | Change from baseline to week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular health, Walking training