Parameters Related to Physical Activity Level in SCI

NCT06089226 | Completed

• 1 other identifier: 23/198
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries; Respiratory Complication; Cardiovascular Complication

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Sociodemographic Information and Health Status Information

  4 weeks

• Body Weight Measurement

  1 week

• Height Measurement

  1 week

• Body mass index

  1 week

• Waist Circumference Measurement

  1 week

Study Arms (1)

Assessment Group

Other: Assessment Group

Interventions

Assessment Group OTHER

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.

Assessment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants diagnosed with spinal cord injury classified as group A, B, C or D according to the American Spinal Injury Association (ASIA)

You may qualify if:

• 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

You may not qualify if:

• Those with any progressive disease
• Bedridden,
• Patients with severe cognitive impairment

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istinye University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 18, 2023
• Study Start: September 20, 2023
• Primary Completion: November 20, 2023
• Study Completion: November 30, 2023
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

TU (1)