Spinal Cord InjuriesNCT06089226
Parameters Related to Physical Activity Level in SCI
An observational study of Spinal Cord Injuries and Respiratory Complication, run by Istinye University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries, Respiratory Complication, Cardiovascular Complication
- What is being tested?
- Assessment Group
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2023to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants diagnosed with spinal cord injury classified as group A, B, C or D according to the American Spinal Injury Association (ASIA)
Who may be able to join
- 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
Who cannot join
- Those with any progressive disease
- Bedridden,
- Patients with severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship Between Physical Activity Level and Cardiovascular Fitness and Respiratory Parameters in Individuals With Spinal Cord Injury
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.
Read more
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.
- Being tested
- Assessment Group
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Assessment Group | Not described Receives: Other: Assessment Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 1 week
Secondary outcomes (5)
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.
Measured: 4 weeks
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.
Measured: 1 week
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.
Measured: 1 week
Body mass index
Body mass index will be calculated as weight (kg) / height² (cm²) and recorded in the evaluation form.
Measured: 1 week
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start20 Sep 2023
- Primary completion20 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubra Koce, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089226
- Sponsor's protocol ID
- 23/198
- Status last verified
- May 2024
- First submitted
- 20 Sep 2023
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Physical Activity Level and Cardiovascular Fitness and Respiratory Parameters in Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06089226
- Acronym / sponsor ID
- 23/198
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment Group | – | Other: Assessment Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed with spinal cord injury classified as group A, B, C or D according to the American Spinal Injury Association (ASIA)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Those with any progressive disease
- Bedridden,
- Patients with severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment GroupIn 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. | Other | Assessment Group |
Primary outcome
Physical Activity Scale for Individuals with Physical Disabilities
Time frame: 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.
The Wheelchair Propulsion Test
Time frame: 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.
Forced vital capacity
Time frame: 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.
Forced expiratory volume in the first second
Time frame: 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.
Forced vital capacity/Forced expiratory volume Ratio
Time frame: 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.
Peak expiratory flow rat
Time frame: 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.
Respiratory muscle strength
Time frame: 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).
5 secondary outcomes
Sociodemographic Information and Health Status Information
Time frame: 4 weeks
Body Weight Measurement
Time frame: 1 week
Height Measurement
Time frame: 1 week
Body mass index
Time frame: 1 week
Waist Circumference Measurement
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Respiratory Complication, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Scale for Individuals with Physical Disabilities (time frame: 1 week). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.