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

Sponsor
Marmara University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04365842
Collaborator
The Scientific and Technological Research Council of Turkey (Other)
40
1
2
9.9
4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Digital exercise group
  • Other: General Home Hand Therapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Development, Feasibility, and Effectiveness of Smartphone Application for Hand Therapy for Patients With Rheumatoid Arthritis: Mix Method Study
Actual Study Start Date :
Nov 2, 2019
Anticipated Primary Completion Date :
Jul 30, 2020
Anticipated Study Completion Date :
Aug 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change from baseline of Hand pain at 7 week [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).

  2. exercise adherance [week 7]

    Qualitative data from smartphone (Time using the app, times of using videos etc)

Secondary Outcome Measures

  1. Change from baseline of Hand Function [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Marmara University Istanbul Turkey 34854

Sponsors and Collaborators

  • Marmara University
  • The Scientific and Technological Research Council of Turkey

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Eda Tonga, Assoc. Prof, Marmara University
ClinicalTrials.gov Identifier:
NCT04365842
Other Study ID Numbers:
  • 09.2019.577
First Posted:
Apr 28, 2020
Last Update Posted:
Apr 28, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eda Tonga, Assoc. Prof, Marmara University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2020