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

NCT04365842 | Unknown

• 1 other identifier: 09.2019.577
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

mhealth; hand exercise; rheumatoid arthritis

Outcome Measures

Primary Outcomes (2)

• Change from baseline of Hand pain at 7 week

  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

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

  week 7

Secondary Outcomes (1)

• Change from baseline of Hand Function

  Baseline and week 7

Study Arms (2)

Digital exercise group

EXPERIMENTAL

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

Waiting list conrol

ACTIVE COMPARATOR

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

Interventions

Digital exercise group 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

Digital exercise group

General Home Hand Therapy 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

Waiting list conrol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Marmara University

Istanbul, 34854, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 29496655 BACKGROUND

• 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.

  PMID: 29237581 BACKGROUND

• 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.

  PMID: 25903352 BACKGROUND

• 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.

  PMID: 29090628 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Eda Tonga, PhD

CONTACT

+905323275451; eda.tonga@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 28, 2020
• Study Start: November 2, 2019
• Primary Completion: July 30, 2020
• Study Completion: August 30, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

TU (1)