Upper Extremity Home Exercises in Patients With Scleroderma

NCT05080738 | Completed

• 1 other identifier: 2021-085
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Scleroderma; System; Sclerosis

Keywords

Scleroderma; Upper extremity exercises; Home exercises; Grip strength

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  8 weeks

Secondary Outcomes (4)

• Score for Assessment and quantification of Chronic Rheumatic Affections of the Hands=SACRAH

  8 weeks

• Duruöz Hand Index (Duruöz Hand Index=DHI/DEI)

  8 weeks

• Range of Motion

  8 weeks

• Disabilities of Arm, Shoulder and Hand questionnaire:

  8 weeks

Study Arms (2)

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.

Other: Upper Extremity Home Exercises

Control

NO INTERVENTION

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

Interventions

Upper Extremity Home Exercises OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a diagnosis of SSc according to 2013 ACR/EULAR criteria
• Having upper extremity/hand involvement
• Voluntary and consent to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 29198478 RESULT

MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Sebahat Yaprak Cetin, PhD

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigators

Model Details: 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.

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 18, 2021
• Study Start: September 10, 2021
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)