Clinical trial NCT05080738: 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
Overall status: COMPLETED
Phase: NA
Conditions: Scleroderma
System; Sclerosis
Keywords: Scleroderma
Upper extremity exercises
Home exercises
Grip strength
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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:

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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Activity Performance
timeFrame: 8 weeks
measure: Grip strength
timeFrame: 8 weeks
Secondary outcomes:
measure: Score for Assessment and quantification of Chronic Rheumatic Affections of the Hands=SACRAH
timeFrame: 8 weeks
measure: Duruöz Hand Index (Duruöz Hand Index=DHI/DEI)
timeFrame: 8 weeks
measure: Range of Motion
timeFrame: 8 weeks
measure: Disabilities of Arm, Shoulder and Hand questionnaire:
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital
Study officials:
affiliation: Akdeniz University
name: Sebahat Yaprak Cetin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.