Physical DisabilityNCT05909449
Improving Posture Parameters of Primary Care Providers to Individuals With Disabilities
A study testing exercises in people with Physical Disability, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this research is to create and implement an exercise program so that primary caregivers can have the correct posture and improve health-related physical fitness parameters. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Disability
- What is being tested?
- exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 May 2023to 3 Jul 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals between the ages of 18-65
- To give primary care to a person with a physical disability
- Being caring for at least 6 months
- Voluntarily performing care
- Being able to understand and read Turkish as a language
- To have sufficient cognitive level to answer the scale questions with the basic interview
- Volunteer to participate in and maintain an exercise program
- Regularly participating in the evaluation and exercise program defined during the project process
Who cannot join
- Caring for a paid job other than voluntarily
- Encountering a disease related to the caregiver during the working process
- Having any known musculoskeletal disease
- Having a known spinal problem such as scoliosis, kyphosis, kyphoscoliosis
- Having undergone surgery affecting the musculoskeletal system in the last 1 month
- History of uncontrollable arrhythmia and/or hypertension
- Having any neurological, cardiovascular, respiratory, orthopedic and metabolic disease that will prevent participation in the exercise program
- Being pregnant for female individuals
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İstanbul Medeniyet University
Istanbul
Gülser Cinbaz, +905558502576, gulser.cinbaz@gmail.com
About this study
Official title: Improving Posture and Health-Related Physical Fitness Parameters of Primary Care Providers to Individuals With Disabilities
The aim of this research is to create and implement an exercise program so that primary caregivers can have the correct posture and improve health-related physical fitness parameters.
Read the detailed description
It is planned to include at least 40 volunteers between the ages of 18-65 who meet the inclusion criteria and provide primary care services to individuals with disabilities who attend Sportive Skills and Coordination Training Centers operating in the provinces of Istanbul and Gaziantep within the body of the Foundation for the Physically Disabled. Musculoskeletal complaints of caregivers related to the care process (neck pain, low back pain and upper extremity pain), physical fitness parameters (functional capacity and shortness-flexibility, balance and footpad pressure distribution), the effects of the caregiving process on the caregiver and mental well-being will be evaluated.
After the first evaluation, the participants will be given an informative training seminar on the effects of exercise on healthy life and the regulation of ergonomics in our behaviors. After the seminar, participants will be included in a structured home exercise program. The home exercise program prepared by the research team and recorded on video will be delivered to the participants. The exercise program will be continued for 6 weeks, 3 days a week. The exercise program will be prepared weekly to advance to the next level. Exercise compliance and attendance will be monitored weekly by the researchers. Evaluations will be repeated at the end of the 6-week exercise program.
Establishment of an exercise program: In the light of the data obtained as a result of the evaluations, an individual-specific exercise program will be created. The exercises will be taught one-on-one to the participants. With the exercise video prepared by the project team and sent to the patients, the participants will be prevented from forgetting the exercises and they will be stimulated to do the exercises correctly. The content of the exercise program will include exercises that include aerobic, strengthening and flexibility components. The exercise program will take approximately 30-45 minutes.
- Conditions
- Physical Disability
- Being tested
- exercises
- Keywords
- posture, Physical Fitness, care provider
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercisesOther
participants will be given a structured home exercise program
| Study group | Role | What they receive |
|---|---|---|
| research group | Experimental | provide primary care services to individuals with physical disabilities Receives: Other: exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Nordic Musculoskeletal Questionnaire
NMQ is a questionnaire that evaluates low back, neck, shoulder and general musculoskeletal complaints with standardized questions. In NMQ; Pain and discomfort in nine mapped and marked areas of the body (feet-ankles, knees, thighs-hips, wrists-hands, waist, elbows, back, shoulders, neck), and whether this is interfering with normal work being questioned
Measured: twice (before and after 6 week exercise program)
Oswestry Low Back Pain Disability Index
It consists of 10 titles (Pain sensitivity, self-care, weight lifting, reading, headaches, concentration, study/work, driving, sleep, and social activities). Each question has 6 answer options that measure the severity of pain or limitation. Scoring is done between 0-5. The total score is between 0-50. There is no limitation between 0-4 points according to the total score; 5-14 mild limitation; 15-24 moderately restricted; 25-34 severe limitation; 34 and above are classified as completely restricted
Measured: twice (before and after 6 week exercise program)
The shortened disabilities of the arm, shoulder and hand questionnaire (Quick DASH)
Q-DASH is a regional outcome measure developed for upper extremity musculoskeletal disorders and includes 11 questions. Each question is scored on a 5-point scale and a final score ranging from 0 (no disability) to 100 (severe disability) is calculated.
Measured: twice (before and after 6 week exercise program)
The Oswestry Disability Index (ODI)
It consists of a total of 10 items measuring the severity of pain, personal care, lifting, walking, sitting, standing, social life, sleeping, traveling and the degree of pain. Each item is graded between 0-5. The maximum score is 50 points; It is evaluated as severe disability between 31-50 points, moderate between 11-30 points and mild disability between 1-10 points.
Measured: twice (before and after 6 week exercise program)
Two Minute Walk Test (2MWT)
2DYT is carried out in a 30 meter long corridor. The starting and ending points are determined by marking the corridor every 3 meters. A colored cone is placed in the turning zones. Participants are asked to walk the 30-meter corridor for 2 minutes at their own walking speed without running. Distance traveled in 2 minutes is recorded
Measured: twice (before and after 6 week exercise program)
Sit and Reach Test
The test will be used to assess lower extremity flexibility. For this test, the participants will be asked to rest their feet on the test bench while in a long sitting position with their knees straight, and without bending their knees, put their hands on each other and extend their arms towards the test bench in front. 3 repetitions will be made and the average value will be recorded.
Measured: twice (before and after 6 week exercise program)
force platform
Balance and sole pressure distribution will be evaluated with the force platform. Balance parameters and footpad pressure distribution evaluations of the cases will be recorded with a force platform (Matscan, TekScan, Boston, MA, USA) with a recording speed of 100Hz and a resolution of 4 senses/cm². Measurements; It will be performed with eyes open and closed, in free standing position and on one foot (first on the dominant, then on the non-dominant foot). For the measurement at each position, force platform records will be taken for 30 seconds. Analysis of the data will be done using Matscan 7.10 (TekScan, Boston, MA) software provided by the manufacturer. To evaluate the balance, center of gravity range of motion (cm2), antero-postero oscillation (cm) and medio-lateral oscillation (cm) values will be recorded.
Measured: twice (before and after 6 week exercise program)
Back reach test
This test evaluates shoulder flexibility. While in a standing position, one arm is externally rotated with the fingers extended and the palm facing the back, reaching the lowest point of the back over the shoulder towards the back and while doing this, the other arm is internally rotated, with the palm facing forward and the fingers again. While in extension, he will be asked to reach the highest point on his back. The distance between the middle fingers placed on the back will be recorded
Measured: twice (before and after 6 week exercise program)
The Zarit Care Burden Scale (ZBVYS)
It was developed by Zarit et al to evaluate the effects of the caregiving process on the caregiver. It consists of 22 statements that determine the effect of caregiving on the life of the individual. Although a maximum of 88 points can be obtained from a 5-point Likert-type scale (1=never, 5=always), higher scores indicate higher caregiving burden
Measured: twice (before and after 6 week exercise program)
Warwick-Edinburgh Mental Well-being
It was developed by Tennant et al. to measure the mental well-being of the caregiver. The scale consists of 14 items covering psychological well-being and subjective well-being. It is a 5-point Likert-type scale, with the lowest 14 points and the highest 70 points. High scores from the scale indicate high mental (psychological) well-being.
Measured: twice (before and after 6 week exercise program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start3 May 2023
- Primary completion21 Jun 2023 (estimated)
- Study completion3 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DisabilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulser CINBAZ, Istanbul Medeniyet University
- Investigators
- NİLÜFER KABLAN, Study director, associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909449
- Sponsor's protocol ID
- 2023-9169
- Status last verified
- Apr 2023
- First submitted
- 10 May 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Posture and Health-Related Physical Fitness Parameters of Primary Care Providers to Individuals With Disabilities
- ClinicalTrials.gov ID
- NCT05909449
- Acronym / sponsor ID
- 2023-9169
- Conditions
- Physical Disability
- Keywords
- posture, Physical Fitness, care provider
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 21 Jun 2023 (estimated)
- Study completion
- 3 Jul 2023 (estimated)
- First posted
- 18 Jun 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.
The aim of this research is to create and implement an exercise program so that primary caregivers can have the correct posture and improve health-related physical fitness parameters.
Detailed description
It is planned to include at least 40 volunteers between the ages of 18-65 who meet the inclusion criteria and provide primary care services to individuals with disabilities who attend Sportive Skills and Coordination Training Centers operating in the provinces of Istanbul and Gaziantep within the body of the Foundation for the Physically Disabled. Musculoskeletal complaints of caregivers related to the care process (neck pain, low back pain and upper extremity pain), physical fitness parameters (functional capacity and shortness-flexibility, balance and footpad pressure distribution), the effects of the caregiving process on the caregiver and mental well-being will be evaluated.
After the first evaluation, the participants will be given an informative training seminar on the effects of exercise on healthy life and the regulation of ergonomics in our behaviors. After the seminar, participants will be included in a structured home exercise program. The home exercise program prepared by the research team and recorded on video will be delivered to the participants. The exercise program will be continued for 6 weeks, 3 days a week. The exercise program will be prepared weekly to advance to the next level. Exercise compliance and attendance will be monitored weekly by the researchers. Evaluations will be repeated at the end of the 6-week exercise program.
Establishment of an exercise program: In the light of the data obtained as a result of the evaluations, an individual-specific exercise program will be created. The exercises will be taught one-on-one to the participants. With the exercise video prepared by the project team and sent to the patients, the participants will be prevented from forgetting the exercises and they will be stimulated to do the exercises correctly. The content of the exercise program will include exercises that include aerobic, strengthening and flexibility components. The exercise program will take approximately 30-45 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| research group | Experimental | Other: exercisesprovide primary care services to individuals with physical disabilities |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Individuals between the ages of 18-65
- To give primary care to a person with a physical disability
- Being caring for at least 6 months
- Voluntarily performing care
- Being able to understand and read Turkish as a language
Key exclusion criteria (8 listed)
- Caring for a paid job other than voluntarily
- Encountering a disease related to the caregiver during the working process
- Having any known musculoskeletal disease
- Having a known spinal problem such as scoliosis, kyphosis, kyphoscoliosis
- Having undergone surgery affecting the musculoskeletal system in the last 1 month
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 |
|---|---|---|
| exercisesparticipants will be given a structured home exercise program | Other | research group |
Primary outcome
The Nordic Musculoskeletal Questionnaire
Time frame: twice (before and after 6 week exercise program)
NMQ is a questionnaire that evaluates low back, neck, shoulder and general musculoskeletal complaints with standardized questions. In NMQ; Pain and discomfort in nine mapped and marked areas of the body (feet-ankles, knees, thighs-hips, wrists-hands, waist, elbows, back, shoulders, neck), and whether this is interfering with normal work being questioned
Oswestry Low Back Pain Disability Index
Time frame: twice (before and after 6 week exercise program)
It consists of 10 titles (Pain sensitivity, self-care, weight lifting, reading, headaches, concentration, study/work, driving, sleep, and social activities). Each question has 6 answer options that measure the severity of pain or limitation. Scoring is done between 0-5. The total score is between 0-50. There is no limitation between 0-4 points according to the total score; 5-14 mild limitation; 15-24 moderately restricted; 25-34 severe limitation; 34 and above are classified as completely restricted
The shortened disabilities of the arm, shoulder and hand questionnaire (Quick DASH)
Time frame: twice (before and after 6 week exercise program)
Q-DASH is a regional outcome measure developed for upper extremity musculoskeletal disorders and includes 11 questions. Each question is scored on a 5-point scale and a final score ranging from 0 (no disability) to 100 (severe disability) is calculated.
The Oswestry Disability Index (ODI)
Time frame: twice (before and after 6 week exercise program)
It consists of a total of 10 items measuring the severity of pain, personal care, lifting, walking, sitting, standing, social life, sleeping, traveling and the degree of pain. Each item is graded between 0-5. The maximum score is 50 points; It is evaluated as severe disability between 31-50 points, moderate between 11-30 points and mild disability between 1-10 points.
Two Minute Walk Test (2MWT)
Time frame: twice (before and after 6 week exercise program)
2DYT is carried out in a 30 meter long corridor. The starting and ending points are determined by marking the corridor every 3 meters. A colored cone is placed in the turning zones. Participants are asked to walk the 30-meter corridor for 2 minutes at their own walking speed without running. Distance traveled in 2 minutes is recorded
Sit and Reach Test
Time frame: twice (before and after 6 week exercise program)
The test will be used to assess lower extremity flexibility. For this test, the participants will be asked to rest their feet on the test bench while in a long sitting position with their knees straight, and without bending their knees, put their hands on each other and extend their arms towards the test bench in front. 3 repetitions will be made and the average value will be recorded.
force platform
Time frame: twice (before and after 6 week exercise program)
Balance and sole pressure distribution will be evaluated with the force platform. Balance parameters and footpad pressure distribution evaluations of the cases will be recorded with a force platform (Matscan, TekScan, Boston, MA, USA) with a recording speed of 100Hz and a resolution of 4 senses/cm². Measurements; It will be performed with eyes open and closed, in free standing position and on one foot (first on the dominant, then on the non-dominant foot). For the measurement at each position, force platform records will be taken for 30 seconds. Analysis of the data will be done using Matscan 7.10 (TekScan, Boston, MA) software provided by the manufacturer. To evaluate the balance, center of gravity range of motion (cm2), antero-postero oscillation (cm) and medio-lateral oscillation (cm) values will be recorded.
Back reach test
Time frame: twice (before and after 6 week exercise program)
This test evaluates shoulder flexibility. While in a standing position, one arm is externally rotated with the fingers extended and the palm facing the back, reaching the lowest point of the back over the shoulder towards the back and while doing this, the other arm is internally rotated, with the palm facing forward and the fingers again. While in extension, he will be asked to reach the highest point on his back. The distance between the middle fingers placed on the back will be recorded
The Zarit Care Burden Scale (ZBVYS)
Time frame: twice (before and after 6 week exercise program)
It was developed by Zarit et al to evaluate the effects of the caregiving process on the caregiver. It consists of 22 statements that determine the effect of caregiving on the life of the individual. Although a maximum of 88 points can be obtained from a 5-point Likert-type scale (1=never, 5=always), higher scores indicate higher caregiving burden
Warwick-Edinburgh Mental Well-being
Time frame: twice (before and after 6 week exercise program)
It was developed by Tennant et al. to measure the mental well-being of the caregiver. The scale consists of 14 items covering psychological well-being and subjective well-being. It is a 5-point Likert-type scale, with the lowest 14 points and the highest 70 points. High scores from the scale indicate high mental (psychological) well-being.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
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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.
NİLÜFER KABLAN study director
associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercises in people with Physical Disability, run by Istanbul Medeniyet 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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 18 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GÜLSER CİNBAZ (05558502576, gulser.cinbaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Nordic Musculoskeletal Questionnaire (time frame: twice (before and after 6 week exercise program)). The study lists 10 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 18 Jun 2023.