Clinical trial NCT03940274: Walk-Training Program for Individuals With Chronic Spinal Cord Injury (SCI)
Official title: Benefits of a Walk-Training Program on Cardiovascular Health in Individuals With Chronic Spinal Cord Injury (SCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Cardiovascular health
Walking training
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The recruitment feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI.
timeFrame: From baseline to week 8
measure: The perception feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI.
timeFrame: From baseline to week 8
measure: The compliance feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI.
timeFrame: From baseline to week 8
measure: The retention feasibility of an 8-week (3 sessions per week, 30 min per session) walk-training program in patients with chronic SCI.
timeFrame: From baseline to week 8
measure: The walking performance (walking time) feasibility of an 8-week walk-training program in patients with chronic SCI.
timeFrame: From baseline to week 8
measure: The walking performance (treadmill walking speed) feasibility of an 8-week walk-training program in patients with chronic SCI.
timeFrame: From baseline to week 8
measure: The walking performance (number of stepping) feasibility of an 8-week walk-training program in patients with chronic SCI.
timeFrame: From baseline to week 8
measure: 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.
timeFrame: Change from baseline to week 8
Secondary outcomes:
measure: Changes in lipid profile after 8-week walk-training program.
timeFrame: Change from baseline to week 8
measure: Changes in the level of glycated hemoglobin (HbA1c) after 8-week walk-training program.
timeFrame: Change from baseline to week 8
measure: Changes in the level of pro-inflammatory markers after 8-week walk-training program.
timeFrame: Change from baseline to week 8
Other outcomes:
measure: Changes in lower-limbs muscle strength after 8-week walk-training program.
timeFrame: Change from baseline to week 8
measure: Changes in lower-limbs muscle spasticity after 8-week walk-training program.
timeFrame: Change from baseline to week 8
measure: Changes in muscle spasticity after 8-week walk-training program.
timeFrame: Change from baseline to week 8
measure: Changes in functional independence after 8-week walk-training program.
timeFrame: Change from baseline to week 8
measure: Changes in the level of depression, anxiety and stress after 8-week walk-training program.
timeFrame: Change from baseline to week 8
measure: Changes in health-related quality of life (HRQOL) after 8-week walk-training program.
timeFrame: Change from baseline to week 8
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Wen Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alajam RA, Alqahtanti AS, Frederick J, Liu W. The feasibility of an 8-Week walking training program using a novel assistive gait training device in individuals with spinal cord injury. Disabil Rehabil Assist Technol. 2022 Aug;17(6):658-667. doi: 10.1080/17483107.2020.1805801. Epub 2020 Aug 11.