Upper Extremity Home Exercises in Patients With Scleroderma

Sponsor

Pamukkale University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05080738

Collaborator

(none)

Enrollment

Location

Arms

2.2

Anticipated Duration (Months)

21.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Scleroderma System; Sclerosis	Other: Upper Extremity Home Exercises	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 seconds10 repetitions for fingers, wrists, elbows and shoulders. Strengthening exercises: It will be applied as 2 sets10 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 (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Investigation of Upper Extremity Home Exercises Effects on Grip Strength, Range of Motion, Activity Performance and Funcionality in Patients With Scleroderma

Anticipated Study Start Date :

Oct 10, 2021

Anticipated Primary Completion Date :

Dec 10, 2021

Anticipated Study Completion Date :

Dec 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Upper Extremity Home Exercises The exercises will be performed as follows: Stretching exercises: It will be applied in the form of 10 seconds10 repetitions for fingers, wrists, elbows and shoulders. Strengthening exercises: It will be applied as 2 sets10 repetitions for fingers, wrists, elbows and shoulders.
No Intervention: Control Education group:Patients will be informed about joint protection principles by a physiotherapist for once.

Arm

Intervention/Treatment

Experimental: 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.

Other: Upper Extremity Home Exercises

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.

No Intervention: Control

Education group:Patients will be informed about joint protection principles by a physiotherapist for once.

Outcome Measures

Primary Outcome Measures

Activity Performance [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 [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.

Secondary Outcome Measures

Score for Assessment and quantification of Chronic Rheumatic Affections of the Hands=SACRAH [8 weeks]
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) [8 weeks]
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 [8 weeks]
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: [8 weeks]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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