Clinical trial NCT04481984: Effectiveness of a Home-based, Self-administered Exercise Program for Hands in Patients With Systemic Sclerosis
Official title: Effectiveness of a Home-based, Self-administered Exercise Program for Hands in Patients With Systemic Sclerosis: a Randomized Controlled, Single-blind, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Sclerosis
Scleroderma
Hand Rheumatism
Rehabilitation
Keywords: Systemic sclerosis
Scleroderma
Hand
Rehabilitation
Exercise therapy
Self-management
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled, Single-blind, Clinical Study
Primary purpose: TREATMENT

Brief summary: Systemic sclerosis (SSc) is a heterogeneous autoimmune disease characterized by fibrosis of the skin and internal organs. Hand involvement is one of the most observed musculoskeletal involvements in patients with SSc, which can impact on general health, quality of life, and psychological status. Hand exercise programs can help patients to improve not only hand function but also general health status; nevertheless, further randomized control trials (RCTs) are needed to clarify its effect. Hence, the investigators aimed to investigate the effectiveness of home-based, self-administered exercise program for hands in patients with SSc and demonstrate the improvements in general health status.

Detailed description: The current study was designed as a single-blind, prospective, randomized controlled, comparative study with a 2-month follow-up period, conducted in a rheumatology outpatient clinic of a university hospital, between July 2016-June 2019. Female patients with SSc who fulfilled the 2013 ACR/EULAR classification criteria for systemic sclerosis were included in the study. Patients with neurological disorders, arthritis, myositis, amputation of fingers, serious contracture resisting handgrip, and history of undergoing hand surgery were excluded from the study. Patients were enrolled in the study after they signed the written informed consent. Following the assessment of patients in terms of eligibility, patients were randomized into an exercise and a control group. The computerized block randomization method was used to randomize subjects into groups. Both groups were informed about systemic sclerosis and they received the printed materials that include recommendations such as avoiding cold and trauma. The treatment group participated in a single hand exercise training (isometric hand exercise and self-administered stretching) applied by a physiatrist. They additionally received the printable instructions for exercises. Compliance was assessed by a checklist, which included all information on how to exercise and how many times to do them. The investigators aimed to investigate the impact of hand exercise program on hand function and demonstrate its influence on health status, quality of life, and psychological status of patients with SSc.

Eligibility criteria: Inclusion Criteria:

- Female systemic sclerosis patients who fulfilled the 2013 ACR/EULAR classification criteria for systemic sclerosis

Exclusion Criteria:

* Patients with neurological disorders,
* Arthritis,
* Myositis,
* Amputation of fingers,
* Serious contracture resisting hand grip
* History of undergoing hand surgery

Primary outcomes:
measure: Handgrip strength
timeFrame: Before treatment to 8 weeks
Secondary outcomes:
measure: Duruoz Hand Index
timeFrame: Before treatment to 8 weeks
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
state: Saricam
Study officials:
References:
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