Telerehabilitation in Patients With Fibromyalgia

NCT ID: NCT06299527

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-27

Study Completion Date

2024-01-27

Brief Summary

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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).

Detailed Description

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Materials and methods: A randomized clinical study. 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

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Synchronous Exercise Group

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.

Group Type EXPERIMENTAL

Exercise Program

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Exercise Program

Intervention Type 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.

Interventions

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Exercise Program

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Eren Timurtas

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Health Sciences

Istanbul, Maltepe, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 14131272 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 6880820 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 19664287 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39905353 (View on PubMed)

Other Identifiers

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01032024

Identifier Type: -

Identifier Source: org_study_id

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