Telerehabilitation in Patients With Fibromyalgia

NCT06299527 | Completed

• 1 other identifier: 01032024
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Sixty-six FMS patients received the same exercise program for 8 weeks and divided, synchronous (n: 33), asynchronous (n: 33). Pain (Visual analog Scale, VAS), functional limitations and disabilities (Revised Fibromyalgia Impact Questionnaire, FEA), health-related quality of life (HRQol; Short Form-12, SF 12), catastrophizing (pain catastrophizing scale, PCS), anxiety and depression (Hospital Anxiety and Depression Scale, HAD), functional capacity (6-minute walking test, 6MWT), muscle strength (Arm curl test) joint position sense (Laser Cursor Assisted Angle Repetition Test, LI-RATT) were assessed at baseline, mid-treatment (week 4), end of treatment (week 8), and eight weeks after treatment (week 16).

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Telerehabilitation; Mobile health

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  A visual analog scale was used to evaluate the patient's pain. This scale is used to quantify pain intensity that cannot be measured numerically. Numbers are written on the two ends of a 10 cm line. The patient is asked to indicate on this line where the pain condition is appropriate during rest by drawing a line, putting a dot or pointing. For pain intensity, according to the scale, "no pain" will be rated as 0 points and "worst pain imaginable" as 10 points. The ranges for pain intensity were determined as \<3 Mild pain, 3-6 moderate pain, 6 and above severe pain.

  at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)

Secondary Outcomes (7)

• Revised Fibromyalgia Impact Questionnaire

  at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)

• Pain Catastrophizing Scale

  at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)

• Hospital Anxiety and Depression Scale

  at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)

• 6 Minute Walk Test

  at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)

• Arm Curl Test

  at baseline at mid-treatment (week 4), at the end of treatment (week 8), and eight weeks after treatment (week 16)

Study Arms (2)

Synchronous Exercise Group

EXPERIMENTAL

Synchronous telerehabilitation was performed via videoconference. Patients were taken to video conference calls accompanied by a researcher and supervisor. Participants were to perform their exercises simultaneously under the guidance of the researcher. Participants were taken to video conference calls in groups of 5 with similar functional levels. Each session lasts an average of 45 minutes. It was last. The start and end date of the exercise program, the number of repetitions for each exercise, the number of sets, daily repetitions, rest time between sets and the order of the exercises were determined by the researcher.

Other: Exercise Program

Asynchronous Exercise Group

ACTIVE COMPARATOR

Asynchronous telerehabilitation was carried out through the mobile application. Researchers created a record for each participant in the mobile application with the personal information of the participants. Participants were logged in to the application with an account address and password created for them. The mobile application was supervised and followed by a researcher. The principal researcher prepared an exercise program specifically for each participant. He sent the exercise program he had prepared to the relevant participants through the application. In the mobile application, all exercises are explained in video and writing.

Other: Exercise Program

Interventions

Exercise Program OTHER

Exercise Program In our study, the telerehabilitation program was applied for both synchronous and asynchronous groups, 3 days a week, 1 session per day, for 8 weeks. The exercises were combined individually according to the person's capacity, and the intensity and duration of the exercise will gradually increase according to the patient's tolerance.

Asynchronous Exercise Group; Synchronous Exercise Group

Eligibility Criteria

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

You may qualify if:

• Diagnosed with FMS by the physician in accordance with ACR 2016 criteria,
• Having independent mobility,
• Not having advanced vision and hearing loss,
• Minimum literacy, participating voluntarily, making video calls, Internet and smartphone access

You may not qualify if:

• Have a rheumatic disease with more prominent symptoms than FMS,
• Have an active infection,
• Have a surgical operation in the last three months,
• Have an uncontrollable chronic disease,
• Have another musculoskeletal disorder

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Faculty of Health Sciences

Istanbul, Maltepe, 1464185881, Turkey (Türkiye)

Location

Related Publications (6)

• BALKE B. A SIMPLE FIELD TEST FOR THE ASSESSMENT OF PHYSICAL FITNESS. REP 63-6. Rep Civ Aeromed Res Inst US. 1963 Apr:1-8. No abstract available.

  PMID: 14131272 BACKGROUND

• Soylu C, Kütük B. "Reliability and validity study of the Turkish form of the SF-12 Quality of Life Scale." Turkish Journal of Psychiatry.2020; 1-9.

  BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Sullivan MJ, Bishop SR, Pivik J. The pain catastrophizing scale: development and validation. Psychological assessment. 1995; 7(4): 524.

  BACKGROUND

• Bennett RM, Friend R, Jones KD, Ward R, Han BK, Ross RL. The Revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric properties. Arthritis Res Ther. 2009;11(4):R120. doi: 10.1186/ar2783. Epub 2009 Aug 10.

  PMID: 19664287 BACKGROUND

• Timurtas E, Huzmeli I, Demirbuken I, Polat MG. Clinical outcomes of asynchronous telerehabilitation through a mobile app are equivalent to synchronous telerehabilitation in patients with fibromyalgia: a randomized control study. BMC Musculoskelet Disord. 2025 Feb 4;26(1):118. doi: 10.1186/s12891-025-08377-6.

  PMID: 39905353 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

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

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 8, 2024
• Study Start: May 27, 2023
• Primary Completion: November 15, 2023
• Study Completion: January 27, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

TU (1)