Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06089226
Other study ID # 23/198
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 20, 2023
Est. completion date November 30, 2023

Study information

Verified date May 2024
Source Istinye University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Spinal cord injury (SCI) is a devastating health condition associated with permanent disability and reduced life expectancy. It is stated that its annual incidence worldwide varies between 12.1 and 57.8 per million, and its prevalence varies between 236 and 1009 per million. SCI negatively affects the physical, psychological, and social well-being of individuals by causing sensory, motor, and autonomic dysfunction. The level of disability associated with SCI is different for each injury and varies depending on the level and type of injury. However, physical activity (PA), cardiovascular fitness, and respiratory system are commonly observed to be affected in most individuals with SCI. Due to inadequate control of somatic and autonomic systems, a decrease in the cardiovascular response to PA and exercise occurs. A decrease in PA level and systemic disorders after injury promote sedentary behavior and negatively affect cardiovascular fitness in individuals with SCI. Cervical and thoracic spinal cord injuries compromise the function of the respiratory muscles and significantly impair both inspiratory and expiratory function. It also interrupts the sympathetic innervation of the lungs and creates restrictive changes in the physiological and mechanical properties of the lungs. The broad effects of SCI on lung capacity may have implications for cardiovascular fitness. Adequate ventilation is critical to provide adequate oxygen to working muscles during prolonged physical activities. During moderate and high-intensity physical activities, ventilation increases in proportion to oxygen consumption to maintain arterial oxygen concentration and allow continuous PA. Knowing the relationship between PA, cardiovascular fitness, and respiratory parameters after SCI is essential in guiding the course of rehabilitation after SCI. Battikha et al. They reported that respiratory capacity plays an important role in limiting exercise capacity in individuals with SCI. However, the relationship between PA and cardiovascular fitness and respiratory parameters has not been fully examined in individuals with SCI. In this study, the investigators hypothesize the relationship between PA, cardiovascular fitness and respiratory parameters. Accordingly, this study aims to determine the relationship between PA, cardiovascular fitness and respiratory parameters in individuals with SCI.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date November 30, 2023
Est. primary completion date November 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Classified as group A, B, C or D (diagnosed with spinal cord injury) according to the American Spinal Injury Association (ASIA), - Fully or partially wheelchair dependent - Having the upper extremity muscle strength required to use a wheelchair - Those who are over 18 years old - Patients without cognitive impairment Exclusion Criteria: - Those with any progressive disease - Bedridden, - Patients with severe cognitive impairment

Study Design


Intervention

Other:
Assessment Group
In our prospectively planned study, patients who meet the inclusion criteria will be evaluated by the researcher via face-to-face interview method and the evaluations specified in the outcome measurements. Patients participating in the study will first be given a general explanation about the purpose of the study and evaluation methods, and their written consent will be obtained.

Locations

Country Name City State
Turkey Istinye University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istinye University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical Activity Scale for Individuals with Physical Disabilities Physical Activity Scale for Individuals with Physical Disabilities will be used to evaluate the physical activity level of individuals with SCI. The scale is a 13-item self-report form for classification purposes covering daily living activities (items 1-6), domestic activities (items 7-12) and professional duties (item 13) in the last seven days.A high score indicates a high level of physical activity. 1 week
Primary The Wheelchair Propulsion Test It will be used to evaluate the cardiovascular fitness level of participants. The test includes a total of 3 tests: 20 Meter Propulsion Test, Slalom Test and 6 Minute Push Test. In the 20 Meter Propulsion Test, the number of seconds in which the participant completes 20 meters is measured with a stopwatch. A high value indicates low cardiovascular fitness. In the Slalom Test, the number of seconds in which the participant completes the 8-way track is measured with a stopwatch. A high value indicates low cardiovascular fitness. In the 6-minute push test, the distance traveled by the participant during 6 minutes is measured in meters. A higher value indicates higher cardiovascular fitness. 1 week
Primary Forced vital capacity Forced vital capacity is the volume of gas expelled from the lungs in a fast, forced and deep expiration after a deep, forced inspiration. Forced vital capacity will be performed in a sitting position using a portable spirometer (Spirobank; MIR, Rome, Italy) according to American Thoracic Society guidelines. 1 week
Primary Forced expiratory volume in the first second Forced expiratory volume in the first second is the amount of air expelled from the lungs in the first second with forced expiration. Forced expiratory volume in the first second will be performed in a sitting position using a portable spirometer (Spirobank; MIR, Rome, Italy) according to American Thoracic Society guidelines. 1 week
Primary Forced vital capacity/Forced expiratory volume Ratio The Forced vital capacity/Forced expiratory volume Ratio, also called the modified Tiffeneau-Pinelli index, is a calculated ratio used in the diagnosis of obstructive and restrictive lung disease. The ratio will be performed in a sitting position using a portable spirometer (Spirobank; MIR, Rome, Italy) according to American Thoracic Society guidelines. 1 week
Primary Peak expiratory flow rat Peak expiratory flow rate is the volume of air forcefully expelled from the lungs in one quick exhalation, and is a reliable indicator of ventilation adequacy as well as airflow obstruction. The ratio will be performed in a sitting position using a portable spirometer (Spirobank; MIR, Rome, Italy) according to American Thoracic Society guidelines. 1 week
Primary Respiratory muscle strength Respiratory muscle strength, maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be assessed using an electronic pressure transducer (MicroRPM; Micro Medical Ltd., Kent, United Kingdom). 1 week
Secondary Sociodemographic Information and Health Status Information Participants' sociodemographic information and health status information will be recorded in the Patient Evaluation Form. The Patient Evaluation Form prepared by the researcher consists of 2 parts. First part; It consists of 15 questions that include information such as the patient's age, gender, height, weight, profession, and educational status. The second part consists of 7 questions containing information such as the cause of injury, ASIA level, neurological injury level, and ambulation level. The answers received from the patients will be recorded in the evaluation form. 4 weeks
Secondary Body Weight Measurement It is a measure that shows the sum of body weight, fat mass and fat-free mass, and is used quite often because it is practical.The body weights of the participants, as described in the literature, will initially be weighed with an electronic scale while they are dressed and sitting in a wheelchair, and then the wheelchair and their clothes will be weighed and subtracted from the total weight. The result will be recorded on the evaluation form in kilograms. 1 week
Secondary Height Measurement The height of the participants will be measured with a non-stretchable tape measure as described in the literature, in the supine position, the head in the Frankfort position, the legs stretched, and the feet in dorsiflexion, and the result will be recorded in the evaluation form in centimeters. 1 week
Secondary Body mass index Body mass index will be calculated as weight (kg) / height² (cm²) and recorded in the evaluation form. 1 week
Secondary Waist Circumference Measurement An easier way to evaluate obesity in individuals with spinal cord injury is waist circumference measurement, which gives an idea about body fat distribution rather than total fat amount. Participants' waist circumferences will be measured with a non-flexible tape measure at the end of normal expiration, with their clothes removed and their arms at their sides, and recorded in centimeters. 1 week
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06321172 - Muscle and Bone Changes After 6 Months of FES Cycling N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05484557 - Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury N/A
Suspended NCT05542238 - The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury N/A
Recruiting NCT05503316 - The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System N/A
Not yet recruiting NCT05506657 - Early Intervention to Promote Return to Work for People With Spinal Cord Injury N/A
Recruiting NCT04105114 - Transformation of Paralysis to Stepping Early Phase 1
Recruiting NCT03680872 - Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System N/A
Completed NCT04221373 - Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation N/A
Completed NCT00116337 - Spinal Cord Stimulation to Restore Cough N/A
Completed NCT03898700 - Coaching for Caregivers of Children With Spinal Cord Injury N/A
Recruiting NCT04883463 - Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury N/A
Active, not recruiting NCT04881565 - Losing Balance to Prevent Falls After Spinal Cord Injury (RBT+FES) N/A
Completed NCT04864262 - Photovoice for Spinal Cord Injury to Prevent Falls N/A
Recruiting NCT04007380 - Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI N/A
Active, not recruiting NCT04544761 - Resilience in Persons Following Spinal Cord Injury
Completed NCT03220451 - Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients N/A
Terminated NCT03170557 - Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation N/A
Recruiting NCT04811235 - Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial N/A
Recruiting NCT04736849 - Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury N/A