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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04481984
Recruitment Status : Completed
First Posted : July 22, 2020
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Neslihan Gokcen, Cukurova University

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.

Condition or disease Intervention/treatment Phase
Systemic Sclerosis Scleroderma Hand Rheumatism Rehabilitation Other: Home-based Hand exercise Other: Care advice Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled, Single-blind, Clinical Study
Masking: Single (Outcomes Assessor)
Masking Description: Single
Primary Purpose: Treatment
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
Actual Study Start Date : July 15, 2016
Actual Primary Completion Date : June 5, 2019
Actual Study Completion Date : June 5, 2019


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 Name: Rehabilitation

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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female patients with Systemic sclerosis
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04481984


Locations
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Turkey
Cukurova University
Adana, Saricam, Turkey, 01330
Sponsors and Collaborators
Cukurova University
  Study Documents (Full-Text)

Documents provided by Neslihan Gokcen, Cukurova University:
Informed Consent Form  [PDF] July 15, 2016

Publications:

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Responsible Party: Neslihan Gokcen, Principal Investigator, Cukurova University
ClinicalTrials.gov Identifier: NCT04481984    
Other Study ID Numbers: Cukurova Uni. Neslihan G.
First Posted: July 22, 2020    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected IPD may be shared with other researches
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Up to 6 months
Access Criteria: Researchers who would like to access to individual participant data will be reviewed and approved by the principal investigator.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Neslihan Gokcen, Cukurova University:
Systemic sclerosis
Scleroderma
Hand
Rehabilitation
Exercise therapy
Self-management
Additional relevant MeSH terms:
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Rheumatic Diseases
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Musculoskeletal Diseases