NCT06006494

Brief Summary

In this study, yoga, aerobic exercise, resistance exercise training in female individuals with fibromyalgia syndrome; It was aimed to compare their effectiveness on fatigue, quality of life and pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

August 17, 2023

Last Update Submit

September 28, 2024

Conditions

Keywords

womensleeptiredness

Outcome Measures

Primary Outcomes (1)

  • Fibromyalgia Impact Questionnaire

    It assesses the impact of fibromyalgia on the patient's health and functional abilities. High scores indicate that the disease affects the person more. The total score can be between 0-80. A score of 80 indicates high influence.

    14 weeks

Study Arms (3)

aerobic group

ACTIVE COMPARATOR

only a separate aerobic exercise will be given

Other: aerobic

resistant group

EXPERIMENTAL

aerobic and resistance exercises will be given

Other: aerobicOther: resistant

yoga group

EXPERIMENTAL

aerobic exercises will be given and yoga will be done

Other: aerobicOther: yoga

Interventions

aerobicOTHER

We can think of aerobic exercise as a low-intensity long-term activity using large muscle groups (between 60-80% of maximal heart rate). For example; includes activities such as walking, cycling, jogging, aerobic dancing, swimming. An average of 50 minutes of exercise per day will be required, 3 days a week.

aerobic groupresistant groupyoga group

Resistance exercises are the whole of the exercises in which effort is made against the weight and the weight is lifted. Exercises with therabands, dumbbells or body weight will be given. The exercises will be done 2 days a week for an average of 30-40 minutes.

resistant group
yogaOTHER

Yoga is basically breathing exercises, warm-up exercises, relaxation, It is a session consisting of movements and relaxation exercises.movements are performed by standing in a fixed posture for 15 seconds to 2 minutes in a certain posture, they are postures for both strengthening, stretching and balance. Yoga practice will be done 2 days a week for an average of 40 minutes.

yoga group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18-45
  • Be woman
  • Being diagnosed with fibromyalgia

You may not qualify if:

  • Receiving pharmacological treatment
  • Having had a surgical operation in the last 6 months
  • Being pregnant
  • Having a musculoskeletal injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar University

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

  • Sosa-Reina MD, Nunez-Nagy S, Gallego-Izquierdo T, Pecos-Martin D, Monserrat J, Alvarez-Mon M. Effectiveness of Therapeutic Exercise in Fibromyalgia Syndrome: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Biomed Res Int. 2017;2017:2356346. doi: 10.1155/2017/2356346. Epub 2017 Sep 20.

    PMID: 29291206BACKGROUND
  • Busch AJ, Webber SC, Brachaniec M, Bidonde J, Bello-Haas VD, Danyliw AD, Overend TJ, Richards RS, Sawant A, Schachter CL. Exercise therapy for fibromyalgia. Curr Pain Headache Rep. 2011 Oct;15(5):358-67. doi: 10.1007/s11916-011-0214-2.

    PMID: 21725900BACKGROUND
  • Bidonde J, Busch AJ, Schachter CL, Overend TJ, Kim SY, Goes SM, Boden C, Foulds HJ. Aerobic exercise training for adults with fibromyalgia. Cochrane Database Syst Rev. 2017 Jun 21;6(6):CD012700. doi: 10.1002/14651858.CD012700.

    PMID: 28636204BACKGROUND
  • Busch AJ, Webber SC, Richards RS, Bidonde J, Schachter CL, Schafer LA, Danyliw A, Sawant A, Dal Bello-Haas V, Rader T, Overend TJ. Resistance exercise training for fibromyalgia. Cochrane Database Syst Rev. 2013 Dec 20;2013(12):CD010884. doi: 10.1002/14651858.CD010884.

    PMID: 24362925BACKGROUND
  • Verma A, Shete SU, Doddoli G. Yoga therapy for fibromyalgia syndrome: A case report. J Family Med Prim Care. 2020 Jan 28;9(1):435-438. doi: 10.4103/jfmpc.jfmpc_816_19. eCollection 2020 Jan.

    PMID: 32110633BACKGROUND
  • Sevgin O, Bugday B, Aydogan Baykara R, Gunendi G, Akkurt B, Atasoy H, Dikmen Hosbas B, Akkurt MF, Karamancioglu B. Efficacy of different exercises in women with fibromyalgia syndrome: a randomised controlled trial. Clin Exp Rheumatol. 2025 Jun;43(6):1010-1018. doi: 10.55563/clinexprheumatol/uol8so. Epub 2025 Feb 12.

MeSH Terms

Conditions

FibromyalgiaFatigue

Interventions

Yoga

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Hilal ATASOY

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Aerobic exercises, resistant exercises and yoga
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst.Prof.Dr.

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 23, 2023

Study Start

September 1, 2023

Primary Completion

December 10, 2023

Study Completion

December 15, 2023

Last Updated

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations