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

NCT ID: NCT04365842

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-02
• Study Completion Date: 2020-08-30

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.

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Digital exercise group

Intervention Type: BEHAVIORAL

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

Waiting list conrol

A hand rehabilitation home program will be given to the patients in the group through the telephone messages with brochures.

Group Type: ACTIVE_COMPARATOR

General Home Hand Therapy

Intervention Type: OTHER

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

Interventions

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

Intervention Type: BEHAVIORAL

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Eda Tonga

Assoc. Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Marmara University

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Eda Tonga, PhD

Role: CONTACT

eda.tonga@gmail.com

+905323275451

Facility Contacts

Eda Tonga, Assoc. Prof

Role: primary

eda.tonga@gmail.com

+905323275451

References

Argent R, Daly A, Caulfield B. Patient Involvement With Home-Based Exercise Programs: Can Connected Health Interventions Influence Adherence? JMIR Mhealth Uhealth. 2018 Mar 1;6(3):e47. doi: 10.2196/mhealth.8518.

Reference Type: BACKGROUND

PMID: 29496655 (View on PubMed)

Srikesavan CS, Williamson E, Eldridge L, Heine P, Adams J, Cranston T, Lamb SE. A Web-Based Training Resource for Therapists to Deliver an Evidence-Based Exercise Program for Rheumatoid Arthritis of the Hand (iSARAH): Design, Development, and Usability Testing. J Med Internet Res. 2017 Dec 13;19(12):e411. doi: 10.2196/jmir.8424.

Reference Type: BACKGROUND

PMID: 29237581 (View on PubMed)

Azevedo R, Bernardes M, Fonseca J, Lima A. Smartphone application for rheumatoid arthritis self-management: cross-sectional study revealed the usefulness, willingness to use and patients' needs. Rheumatol Int. 2015 Oct;35(10):1675-85. doi: 10.1007/s00296-015-3270-9. Epub 2015 Apr 24.

Reference Type: BACKGROUND

PMID: 25903352 (View on PubMed)

Choi W, Zheng H, Franklin P, Tulu B. mHealth technologies for osteoarthritis self-management and treatment: A systematic review. Health Informatics J. 2019 Sep;25(3):984-1003. doi: 10.1177/1460458217735676. Epub 2017 Nov 1.

Reference Type: BACKGROUND

PMID: 29090628 (View on PubMed)

Other Identifiers

09.2019.577

Identifier Type: -

Identifier Source: org_study_id