Upper Extremity Home Exercises in Patients With Scleroderma
Primary Purpose
Scleroderma, System; Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Upper Extremity Home Exercises
Sponsored by
About this trial
This is an interventional treatment trial for Scleroderma focused on measuring Scleroderma, Upper extremity exercises, Home exercises, Grip strength
Eligibility Criteria
Inclusion Criteria:
- Having a diagnosis of SSc according to 2013 ACR/EULAR criteria
- Having upper extremity/hand involvement
- Voluntary and consent to participate in the study
Exclusion Criteria:
- 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
Sites / Locations
- Antalya Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control
Arm Description
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.
Education group:Patients will be informed about joint protection principles by a physiotherapist for once.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
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.
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05080738
Brief Title
Upper Extremity Home Exercises in Patients With Scleroderma
Official Title
Investigation of Upper Extremity Home Exercises Effects on Grip Strength, Range of Motion, Activity Performance and Funcionality in Patients With Scleroderma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, System; Sclerosis
Keywords
Scleroderma, Upper extremity exercises, Home exercises, Grip strength
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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:
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.
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Education group:Patients will be informed about joint protection principles by a physiotherapist for once.
Intervention Type
Other
Intervention Name(s)
Upper Extremity Home Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Activity Performance
Description
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.
Time Frame
8 weeks
Title
Grip strength
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Score for Assessment and quantification of Chronic Rheumatic Affections of the Hands=SACRAH
Description
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
Time Frame
8 weeks
Title
Duruöz Hand Index (Duruöz Hand Index=DHI/DEI)
Description
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.
Time Frame
8 weeks
Title
Range of Motion
Description
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.
Time Frame
8 weeks
Title
Disabilities of Arm, Shoulder and Hand questionnaire:
Description
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).
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Having a diagnosis of SSc according to 2013 ACR/EULAR criteria
Having upper extremity/hand involvement
Voluntary and consent to participate in the study
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebahat Yaprak Cetin, PhD
Organizational Affiliation
Akdeniz University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antalya Training and Research Hospital
City
Antalya
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
29198478
Citation
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.
Results Reference
result
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Upper Extremity Home Exercises in Patients With Scleroderma
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