Effectiveness of a Home-based, Self-administered Exercise Program for Hands in Patients With Systemic Sclerosis

July 19, 2020 updated by: Neslihan Gokcen, Cukurova University

Effectiveness of a Home-based, Self-administered Exercise Program for Hands in Patients With Systemic Sclerosis: a Randomized Controlled, Single-blind, Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Saricam
      • Adana, Saricam, Turkey, 01330
        • Cukurova University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise group
The training including isometric and stretching hand exercise was applied once by a physiatrist. A hand exercise ball was used for isometric exercise. Patients performed both stretching exercises and isometric exercises according to the training and printed materials. The home-based exercise program was implemented 7 days per week during an 8-week period. In addition, patients received recommendations such as avoiding cold exposure and trauma.
Other: Home-based Hand exercise

Isometric exercise; patients squeezed a hand exercise ball for 60 seconds. This exercise repeated 15-times/3 set per day.

Stretching exercises; self-administered stretching exercises were as follows; i) forearm supination and pronation, ii) wrist flexion and extension, iii) finger flexion, extension, and abduction iv) thumb flexion, extension, and abduction. These exercises repeated 10-times/2 set per day.

Other Names:
  • Rehabilitation
Other: Control group
Patients received care advice including avoiding cold exposure and trauma.
Other: Care advice
Patients received care advice including avoiding cold exposure and trauma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Handgrip strength
Time Frame: Before treatment to 8 weeks
Handgrip strength was measured by hydraulic hand dynamometer (JAMAR®,USA) according to the standard protocol, which calculates the average of three consecutive measurements of the dominant hand. The measurements were recorded as kilograms (kg).
Before treatment to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duruoz Hand Index
Time Frame: Before treatment to 8 weeks
Duruoz Hand Index (DHI) is the 18-item questionnaire assessing hand skill in the kitchen, during dressing, while performing personal hygiene, while performing office tasks, and other general performances. Each item is rated from 0 (no difficulty) to 5 (impossible to do). The sum of the scores varies between 0 and 90. Higher scores indicate the impaired hand function.
Before treatment to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2016

Primary Completion (Actual)

June 5, 2019

Study Completion (Actual)

June 5, 2019

Study Registration Dates

First Submitted

July 12, 2020

First Submitted That Met QC Criteria

July 19, 2020

First Posted (Actual)

July 22, 2020

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 19, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cukurova Uni. Neslihan G.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All collected IPD may be shared with other researches

IPD Sharing Time Frame

Up to 6 months

IPD Sharing Access Criteria

Researchers who would like to access to individual participant data will be reviewed and approved by the principal investigator.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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