CClinicalTrials.gg
CompletedNCT06791954Updated Jan 24, 2025

The Efficacy of a Telerehabilitation Pilates Program in Fibromyalgia Syndrome Patients

An interventional study of Exercise in Fibromyalgia Syndrome, sponsored by Necmettin Erbakan University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-24.

Sponsored by Necmettin Erbakan University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jun 2024, registered Jan 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

The study aims to evaluate the effects of a telerehabilitation-based clinical pilates program in patients with fibromyalgia syndrome. A randomized controlled trial was designed. An online clinical Pilates-based exercise program targeting stability and strength that was conducted for 8 weeks with 2 sessions per week was developed for the telerehabilitation group. The same exercise programs for the control group were provided in brochures.

02

Conditions studied

  • Fibromyalgia Syndrome

Keywords

  • Fibromyalgia
  • Pain
  • Telehealth
  • Telemedicine
03

In context

Fibromyalgia

1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.

This study's enrollment of 45 is below the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Necmettin Erbakan University is the lead sponsor of 198 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Diagnosis of FMS at least one year before the study
  • Stable general health condition for the past 6 months

Exclusion criteria

Exclusion Criteria:

  • Inability to cooperate with measurements
  • Regular engagement in exercise
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Active comparator
    Telerehabilitation group

    Telerehabilitation group

    Other: Exercise

  • Other
    Control group

    Control group

    Other: Exercise

  • No intervention
    Healthy Control Group

    The first results were compared

Interventions

  • OtherExercise

    Clinical pilates program

06

What researchers measure

Primary outcomes

  1. Ultrasonographic assessment

    A 9 MHz linear probe was utilized to determine the transversus abdominis, external oblique, and internal oblique muscles. For the ultrasonographic evaluation of the lumbar multifidus muscles, subjects were positioned in supine and prone positions. A 1.5-6 MHz convex probe was initially placed in a transverse orientation to cover the L4-L5-S1 anatomical region.

    Time frame: First day (at beginning) and last day (8. weeks)

  2. McGill core endurance tests

    The lumbopelvic stability was conducted using McGill core endurance tests, which included tests for trunk flexion, extension, and right and left lateral flexion endurance.

    Time frame: First day (at beginning) and last day (8. weeks)

  3. Fibromyalgia Impact Questionnaire

    The Fibromyalgia Impact Questionnaire (FIQ) is a measure consisting of 10 items that assess physical function, work status, productivity level, depression, anxiety, sleep, pain, stiffness, fatigue, and overall well-being. Higher scores indicate higher disease activity.

    Time frame: First day (at beginning) and last day (8. weeks)

  4. Fatigue Severity Scale

    Fatigue Severity Scale (FSS) consists of a total of nine items. Each item is scored on a scale from 1 to 7. An increase in the total score indicates a higher level of fatigue severity.

    Time frame: First day (at beginning) and last day (8. weeks)

  5. Central Sensitization Inventory Short-Form

    Central Sensitization Inventory Short Form (CSI-SF) is designed to assess the presence of central sensitization and associated symptoms. The total score ranges from 0 to 36, with higher scores indicating greater severity of central sensitization.

    Time frame: First day (at beginning) and last day (8. weeks)

  6. Hospital Anxiety and Depression Scale

    The Hospital Anxiety and Depression Scale comprises 14 items. Odd-numbered items assess anxiety, while even-numbered items evaluate depression. The lowest possible score for each subscale is 0, and the highest is 21.

    Time frame: First day (at beginning) and last day (8. weeks)

  7. Numeric Rating Scale

    The Pain Numeric Rating Scale is a numerical version of the visual analog scale, where patients are asked to indicate the number that best reflects their pain severity on a scale from 0 to 10.

    Time frame: First day (at beginning) and last day (8. weeks)

07

Study locations

1 site
  • Necmettin Erbakan University
    Konya, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06791954
Lead sponsor
Necmettin Erbakan University
Responsible party
YASEMİN MİRZA (Research Assistant, Necmettin Erbakan University) — Principal investigator
First posted
Jan 24, 2025
Start date
Jun 15, 2024
Primary completion
Aug 15, 2024
Completion
Nov 20, 2024
Last update
Jan 24, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion