Parameters Related to Physical Activity Level in SCI

Sponsor
Istinye University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06089226
Collaborator
(none)
50
1
1.3
38

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Assessment Group

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
The Relationship Between Physical Activity Level and Cardiovascular Fitness and Respiratory Parameters in Individuals With Spinal Cord Injury
Actual Study Start Date :
Sep 20, 2023
Anticipated Primary Completion Date :
Oct 20, 2023
Anticipated Study Completion Date :
Oct 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Assessment Group

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.

Outcome Measures

Primary Outcome Measures

  1. Physical Activity Scale for Individuals with Physical Disabilities [1 week]

    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.

  2. The Wheelchair Propulsion Test [1 week]

    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.

  3. Forced vital capacity [1 week]

    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.

  4. Forced expiratory volume in the first second [1 week]

    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.

  5. Forced vital capacity/Forced expiratory volume Ratio [1 week]

    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.

  6. Peak expiratory flow rat [1 week]

    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.

  7. Respiratory muscle strength [1 week]

    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).

Secondary Outcome Measures

  1. Sociodemographic Information and Health Status Information [4 weeks]

    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.

  2. Body Weight Measurement [1 week]

    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.

  3. Height Measurement [1 week]

    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.

  4. Body mass index [1 week]

    Body mass index will be calculated as weight (kg) / height² (cm²) and recorded in the evaluation form.

  5. Waist Circumference Measurement [1 week]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istinye University Istanbul Turkey

Sponsors and Collaborators

  • Istinye University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kubra Koce, Lecturer, Istinye University
ClinicalTrials.gov Identifier:
NCT06089226
Other Study ID Numbers:
  • 23/198
First Posted:
Oct 18, 2023
Last Update Posted:
Oct 18, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 18, 2023