Effectiveness of Technology-Supported Hand Strengthening and Stretching Exercises in Patients With Rheumatoid Arthritis

April 27, 2020 updated by: Eda Tonga, Marmara University

Development, Feasibility, and Effectiveness of Smartphone Application for Hand Therapy for Patients With Rheumatoid Arthritis: Mix Method Study

Growing research evidence supports the effectiveness of mHealth interventions for improving exercise adherence and motivation. The aims of our study are; 1) to develop and design a smartphone application for a structured hand exercise program for patients with RA and to test its usability. 2) Evaluate the feasibility and effectiveness of hand exercise app. This study is a mixed-methods study that aims to investigate the effectiveness of the Mar-HandTherapy app: a qualitative and quantitative study with the iterative design approach.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The long-term beneficial effects of strengthening and stretching for rheumatoid arthritis (RA) for hand programs (SARAH) on functions have been shown in recent studies. Also, recently a usable web-based hand exercise program developed for patients with RA in UK. 1- The aim of our study is to develop and design a smartphone application for structured hand exercise program for patients with RA and to test its usability. 2- Evaluate the feasibility and effectiveness of smartphone app hand exercise app. In our study, a qualitative iterative design approach that includes focus groups of experts/patients was used. The mobile application was designed in 3 phases: PHASE 1: we conducted focus group meetings to compromise the content, feature and design of app in the first phase (Prototype version of smartphone software for RA hand training program/Mar-Hand-Therapy app). Focus Group were consisted two physiotherapist (PT), three hand therapists (HT) working in the field in different rheumatology or hand rehabilitation clinics, two software-computer engineers, 3 patients with RA who had previously participated hand therapy. All focus group members (n=10) and 6 patients used the app for one week. All users filled the usability questionnaire, made the comments and advises. The revised version was tested again for one week. The last revised version completed after two weeks tested. 40 patients diagnosed with rheumatoid arthritis will be included to the study. Participants randomized to digital intervention and waiting list control. After the 6-week digital intervention qualitative interviews have done with 6-15 patients from intervention group to assess the feasibility of digital intervention. The primary outcomes are hand pain and function and exercise adherence.

Study Type

Interventional

Enrollment (Anticipated)

40

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
      • Istanbul, Turkey, 34854
        • Recruiting
        • Marmara University
        • Contact:

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Those diagnosed with rheumatoid arthritis according to ARA criteria
  • RA patients with stage 2 or 3 according to ACR criteria
  • The first symptoms started at least a year ago and those who are undergoing medical treatment
  • Those between the ages of 18-65

Exclusion Criteria:

  • Those who are in the inflammatory period
  • Those who have had surgery for neurological, orthopedic or other reasons recently
  • Those with specified depression or other psychological diagnosis
  • Those who have received physiotherapy and ergotherapy in the past year

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital exercise group

After the 6-week digital intervention, 1) qualitative interviews have done with 6-15 patients from intervention group to assess the feasibility of digital intervention.

2) The primary outcomes are hand pain and function and exercise adherence will be evaluated for all participants
Behavioral: Digital exercise group

Hand Rehabilitation Program: Developed hand exercise smartphone app which include: Self-assessment, (b) self-monitoring (c) exercises types/frequency/ diary, (d) patient education, (e) behavioral change and encouragement (f) exercise adherence Sample exercises

  1. Hand and finger movements: 6-8 repetitions, according to the diagnosis of the patient
  2. Strengthening exercises of hand and finger muscles
  3. Exercises to increase grip and pinch strength
  4. Exercises to increase tendon swing and pull angle
Active Comparator: Waiting list conrol
A hand rehabilitation home program will be given to the patients in the group through the telephone messages with brochures.
Other: General Home Hand Therapy

Hand rehabilitation home program will be given to the through the telephone messages with brochures.

  1. Hand and finger movements: 6-8 repetitions, according to the diagnosis of the patient
  2. Strengthening exercises of hand and finger muscles
  3. Exercises to increase grip and pinch strength
  4. Exercises to increase tendon swing and pull angle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of Hand pain at 7 week
Time Frame: Baseline and week 7

Measurement of health perspective with 100 mm visual analogue scale (VAS). We assess the hand pain score change from baseline scores at 7th week.

The leftmost value in the 100mm horizontal line used for VAS is scored between 0 mm (no pain) and the rightmost value is rated between 100mm (unbearable pain).
Baseline and week 7
exercise adherance
Time Frame: week 7
Qualitative data from smartphone (Time using the app, times of using videos etc)
week 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of Hand Function
Time Frame: Baseline and week 7
Measure of Activity Performance in the Hand (MAP-HAND). It consists of 18 questions. Each question scores between 0 and 3 points. It worsens as the total score increases.We assess the hand function score change from baseline. scores at 7th week.
Baseline and week 7

Collaborators and Investigators

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

Sponsor

Marmara University

Collaborators

The Scientific and Technological Research Council of Turkey

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)

November 2, 2019

Primary Completion (Anticipated)

July 30, 2020

Study Completion (Anticipated)

August 30, 2020

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 27, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2019.577

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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