SclerodermaNCT05080738
Upper Extremity Home Exercises in Patients With Scleroderma
A study testing Upper Extremity Home Exercises in people with Scleroderma and System; Sclerosis, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Hand involvement in scleroderma leads to functional disability due to the relationship between grip strength, wrist and finger movement. The vast majority of patients report that their activities are restricted and their quality of life decreases for this reason. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Scleroderma, System; Sclerosis
- What is being tested?
- Upper Extremity Home Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2021to 15 Jun 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a diagnosis of SSc according to 2013 ACR/EULAR criteria
- Having upper extremity/hand involvement
- Voluntary and consent to participate in the study
Who cannot join
- Having a known diagnosis of additional rheumatological disease
- Diagnosis of any known non-rheumatic disease
- Existence of deformity that prevents doing the exercises
- Presence of active digital ulcer Being involved in another rehabilitation program
- Having cognitive disorder
- Failure to give consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya
About this study
Official title: Investigation of Upper Extremity Home Exercises Effects on Grip Strength, Range of Motion, Activity Performance and Funcionality in Patients With Scleroderma
Hand involvement in scleroderma leads to functional disability due to the relationship between grip strength, wrist and finger movement. The vast majority of patients report that their activities are restricted and their quality of life decreases for this reason. Literature indicate that more work is needed to continue to develop and evaluate rehabilitation interventions in this population.
This study is a randomized controlled study examining the effects of 8 weeks of upper extremity home exercises on grip strength, normal joint movement, activity performance and functionality in patients with scleroderma. In our study, it is aimed to contribute to the standardization of upper extremity exercise protocols for scleroderma patients, to increase the quality of life of patients and to increase their independence in daily living activities.
Read the detailed description
The primary aim of the study is to examine the effects of upper extremity exercises on joint range of motion, grip strength, activity performance and functionality in patients with scleroderma, and thus contribute to the standardization of exercise protocols for the upper extremity in patients with scleroderma. The secondary aim of the study is to ensure the independence of scleroderma patients in their daily living activities and to increase their quality of life.
At least 46 scleroderma patients meeting the inclusion criteria will be included in the study. Demographic information form, Canadian Activity Performance Measurement (COPM), Arm, Shoulder and Hand Problems Questionnaire (DASH), Chronic Rheumatological Influence of the Hands Assessment and Measurement Score Questionnaire (SACRAH), Duruöz Hand Index (DHI) will be applied to the patients, upper extremity joint range of motion will be applied, gross and fine grip strength measurements will be made.
After the initial evaluation, patients will be randomized to intervention and control groups. Upper extremity home exercises including stretching and strengthening will be taught to the intervention group, and they will be asked to do it 5 days a week for 8 weeks. For eight weeks, the patients will be supported by the phone by the physiotherapist and it will be checked whether they do the exercises. The control group will be trained on the principles of joint protection. At the end of eight weeks, patients will have their final evaluation and analysis.
- Conditions
- Scleroderma, System; Sclerosis
- Being tested
- Upper Extremity Home Exercises
- Keywords
- Scleroderma, Upper extremity exercises, Home exercises, Grip strength
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper Extremity Home ExercisesOther
The exercises will be performed as follows:
- Stretching exercises: It will be applied in the form of 10 seconds*10 repetitions for fingers, wrists, elbows and shoulders.
- Strengthening exercises: It will be applied as 2 sets*10 repetitions for fingers, wrists, elbows and shoulders.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The patients in the intervention group will be asked to practice upper extremity home exercises including stretching, mobility and strengthening, as home exercises, 5 days a week for 8 weeks, which will be taught by the physiotherapist. Receives: Other: Upper Extremity Home Exercises |
| Control | No intervention | Education group:Patients will be informed about joint protection principles by a physiotherapist for once. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity Performance
Canadian Activity Performance Measure (Canadian Occupational Performance Measure=COPM/COPM): COPM is a standard measurement tool used to identify an individual's activity performance problems and measure performance satisfaction. COPM is administered as a semi-structured interview. The patient is asked to identify, discuss and rank certain activities that cause him or her difficulty. The five most important issues (as chosen by the patient) are recorded and the patient is asked to indicate their perception of how well they are currently performing the task and to rate how satisfied they are with this level of performance on a scale of 1 to 10 (1-5 not able to / not at all satisfied). not staying and being able to do it very well / extremely satisfied). Performance (COPM-P) and satisfaction (COPM-S) scores are summed separately and divided by five (number of problem areas). This gives average performance and satisfaction scores.
Measured: 8 weeks
Grip strength
Gross grip strength will be measured with a hand dynamometer (Jamar) 3 times for both hands while the patient is sitting with the elbows bent at 90 degrees near the body and the average will be taken.
Fine grip strength will be measured and recorded with a pinchmeter as lateral, triple and fingertip.
Measured: 8 weeks
Secondary outcomes (4)
Score for Assessment and quantification of Chronic Rheumatic Affections of the Hands=SACRAH
The newly developed questionnaire SACRAH includes 23 VASs covering three symptom categories (function, joint stiffness, pain) that primarily determine the status of patients with rheumatic diseases of the hand. The first part consists of 17 questions evaluating hand function. The determined daily activities are eval
Measured: 8 weeks
Duruöz Hand Index (Duruöz Hand Index=DHI/DEI)
It consists of 18 items evaluating hand and wrist activities. The answers are evaluated on a 6-level (0-5) Likert scale and the total score ranges from 0 to 90. The degree of difficulty of the patients in trying to perform these daily activities without using any assistive devices is scored. If the patient can perform this activity without any difficulty, it is scored 0, 1 if it can be done with little difficulty, 2 if it can be done with a little difficulty, 3 if it is very difficult, 4 if it is almost impossible to perform this activity, and 5 if it is completely impossible. The values given for each activity are summed at the end of the index and this value gives the patient's DHI value.
Measured: 8 weeks
Range of Motion
Flexion and extension range of motion will be measured and recorded by the physiotherapist passively and actively with universal goniometer and finger goniometer at appropriate positions.
Measured: 8 weeks
Disabilities of Arm, Shoulder and Hand questionnaire:
It consists of three parts: The first part consists of 30 questions; 21 questions assess the patient's difficulty during activities of daily living, 5 questions assess symptoms (pain, activity-related pain, tingling, stiffness, weakness), and 4 questions assess social function, work, sleep and self-confidence of the patient. In all questions, the patient marks the appropriate answer according to the 5-point Likert system (1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: not at all). The scores for each section are summed and divided by the number of questions and '1' is subtracted from the result. The result found is multiplied by 25. Results from 0 to 100 are obtained from each section (0: no disability, 100: maximum disability).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start10 Sep 2021
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SclerodermaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1\) Intervention Group: The patients in the intervention group will be asked to practice upper extremity home exercises including stretching, mobility and strengthening, as home exercises, 5 days a week for 8 weeks, which will be taught by the physiotherapist. The exercises will be performed as follows: 1. Stretching exercises: It will be applied in the form of 10 seconds\*10 repetitions for fingers, wrists, elbows and shoulders. 2. Strengthening exercises: It will be applied as 2 sets\*10 repetitions for fingers, wrists, elbows and shoulders. Patients will be instructed to perform the exercises according to their pain tolerance. The compliance of the patients with the exercise will be checked during this process and the evaluations will be repeated at the end of 8 weeks. 2\) Control Group: The patients in the control group will be taught the principles of joint protection and evaluations will be made again after 8 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebahat Yaprak Cetin,PT, Pamukkale University
- Investigators
- Sebahat Yaprak Cetin, PhD, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080738
- Sponsor's protocol ID
- 2021-085
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is a randomized controlled trial. Data will record on Statistical Package for the Social Sciences and the data will share wih all researches which will be included the study.
Publications
Landim SF, Bertolo MB, Marcatto de Abreu MF, Del Rio AP, Mazon CC, Marques-Neto JF, Poole JL, de Paiva Magalhaes E. The evaluation of a home-based program for hands in patients with systemic sclerosis. J Hand Ther. 2019 Jul-Sep;32(3):313-321. doi: 10.1016/j.jht.2017.10.013. Epub 2017 Dec 1.
PubMed 29198478
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Upper Extremity Home Exercises Effects on Grip Strength, Range of Motion, Activity Performance and Funcionality in Patients With Scleroderma
- ClinicalTrials.gov ID
- NCT05080738
- Acronym / sponsor ID
- 2021-085
- Conditions
- Scleroderma, System; Sclerosis
- Keywords
- Scleroderma, Upper extremity exercises, Home exercises, Grip strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 18 Oct 2021 (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.
Hand involvement in scleroderma leads to functional disability due to the relationship between grip strength, wrist and finger movement. The vast majority of patients report that their activities are restricted and their quality of life decreases for this reason. Literature indicate that more work is needed to continue to develop and evaluate rehabilitation interventions in this population.
This study is a randomized controlled study examining the effects of 8 weeks of upper extremity home exercises on grip strength, normal joint movement, activity performance and functionality in patients with scleroderma. In our study, it is aimed to contribute to the standardization of upper extremity exercise protocols for scleroderma patients, to increase the quality of life of patients and to increase their independence in daily living activities.
Detailed description
The primary aim of the study is to examine the effects of upper extremity exercises on joint range of motion, grip strength, activity performance and functionality in patients with scleroderma, and thus contribute to the standardization of exercise protocols for the upper extremity in patients with scleroderma. The secondary aim of the study is to ensure the independence of scleroderma patients in their daily living activities and to increase their quality of life.
At least 46 scleroderma patients meeting the inclusion criteria will be included in the study. Demographic information form, Canadian Activity Performance Measurement (COPM), Arm, Shoulder and Hand Problems Questionnaire (DASH), Chronic Rheumatological Influence of the Hands Assessment and Measurement Score Questionnaire (SACRAH), Duruöz Hand Index (DHI) will be applied to the patients, upper extremity joint range of motion will be applied, gross and fine grip strength measurements will be made.
After the initial evaluation, patients will be randomized to intervention and control groups. Upper extremity home exercises including stretching and strengthening will be taught to the intervention group, and they will be asked to do it 5 days a week for 8 weeks. For eight weeks, the patients will be supported by the phone by the physiotherapist and it will be checked whether they do the exercises. The control group will be trained on the principles of joint protection. At the end of eight weeks, patients will have their final evaluation and analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 1) Intervention Group: The patients in the intervention group will be asked to practice upper extremity home exercises including stretching, mobility and strengthening, as home exercises, 5 days a week for 8 weeks, which will be taught by the physiotherapist. The exercises will be performed as follows: 1. Stretching exercises: It will be applied in the form of 10 seconds*10 repetitions for fingers, wrists, elbows and shoulders. 2. Strengthening exercises: It will be applied as 2 sets*10 repetitions for fingers, wrists, elbows and shoulders. Patients will be instructed to perform the exercises according to their pain tolerance. The compliance of the patients with the exercise will be checked during this process and the evaluations will be repeated at the end of 8 weeks. 2) Control Group: The patients in the control group will be taught the principles of joint protection and evaluations will be made again after 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Upper Extremity Home ExercisesThe patients in the intervention group will be asked to practice upper extremity home exercises including stretching, mobility and strengthening, as home exercises, 5 days a week for 8 weeks, which will be taught by the physiotherapist. |
| Control | No intervention | –Education group:Patients will be informed about joint protection principles by a physiotherapist for once. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having a diagnosis of SSc according to 2013 ACR/EULAR criteria
- Having upper extremity/hand involvement
- Voluntary and consent to participate in the study
Key exclusion criteria (6 listed)
- Having a known diagnosis of additional rheumatological disease
- Diagnosis of any known non-rheumatic disease
- Existence of deformity that prevents doing the exercises
- Presence of active digital ulcer Being involved in another rehabilitation program
- Having cognitive disorder
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 |
|---|---|---|
| Upper Extremity Home ExercisesThe exercises will be performed as follows: 1. Stretching exercises: It will be applied in the form of 10 seconds*10 repetitions for fingers, wrists, elbows and shoulders. 2. Strengthening exercises: It will be applied as 2 sets*10 repetitions for fingers, wrists, elbows and shoulders. | Other | Intervention group |
Primary outcome
Activity Performance
Time frame: 8 weeks
Canadian Activity Performance Measure (Canadian Occupational Performance Measure=COPM/COPM): COPM is a standard measurement tool used to identify an individual's activity performance problems and measure performance satisfaction. COPM is administered as a semi-structured interview. The patient is asked to identify, discuss and rank certain activities that cause him or her difficulty. The five most important issues (as chosen by the patient) are recorded and the patient is asked to indicate their perception of how well they are currently performing the task and to rate how satisfied they are with this level of performance on a scale of 1 to 10 (1-5 not able to / not at all satisfied). not staying and being able to do it very well / extremely satisfied). Performance (COPM-P) and satisfaction (COPM-S) scores are summed separately and divided by five (number of problem areas). This gives average performance and satisfaction scores.
Grip strength
Time frame: 8 weeks
Gross grip strength will be measured with a hand dynamometer (Jamar) 3 times for both hands while the patient is sitting with the elbows bent at 90 degrees near the body and the average will be taken. Fine grip strength will be measured and recorded with a pinchmeter as lateral, triple and fingertip.
4 secondary outcomes
Score for Assessment and quantification of Chronic Rheumatic Affections of the Hands=SACRAH
Time frame: 8 weeks
Duruöz Hand Index (Duruöz Hand Index=DHI/DEI)
Time frame: 8 weeks
Range of Motion
Time frame: 8 weeks
Disabilities of Arm, Shoulder and Hand questionnaire:
Time frame: 8 weeks
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 12 Oct 2022.
- Results publication: PubMed 29198478Landim SF, Bertolo MB, Marcatto de Abreu MF, Del Rio AP, Mazon CC, Marques-Neto JF, Poole JL, de Paiva Magalhaes E. The evaluation of a home-based program for hands in patients with systemic sclerosis. J Hand Ther. 2019 Jul-Sep;32(3):313-321. doi: 10.1016/j.jht.2017.10.013. Epub 2017 Dec 1.
- Individual participant dataSharing planned: No. This study is a randomized controlled trial. Data will record on Statistical Package for the Social Sciences and the data will share wih all researches which will be included the study.
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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.
Sebahat Yaprak Cetin, PhD principal investigator
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper Extremity Home Exercises in people with Scleroderma and System; Sclerosis, run by Pamukkale 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 3 inclusion and 6 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 12 Oct 2022. 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?
Activity Performance (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05080738, which also lists 1 linked publication.
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 12 Oct 2022.