Clinical trial NCT04426864: Efficacy of Different Types of Exercises in Women With Fibromyalgia Syndrome.
Official title: Efficacy of Different Types of Exercises on Pain, Quality of Life, Depression, and Body Composition in Women With Fibromyalgia Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia Syndrome
Keywords: Fibromyalgia
Aerobic exercise
Resistance exercise
Stretching exercise
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to three groups in parallel for the duration of the study.
Primary purpose: TREATMENT

Brief summary: Objective: To demonstrate the most effective exercise intervention for women with fibromyalgia syndrome on the pain, quality of life, depression, and body composition through a comparative study of three types of exercise intervention: supervised aerobic plus stretching, supervised resistance plus stretching, and home-based stretching.

Detailed description: Objective: To demonstrate the most effective exercise intervention for women with fibromyalgia syndrome on the pain, quality of life, depression, and body composition through a comparative study of three types of exercise intervention.

Methods: Eighty-four patients women with fibromyalgia syndrome were assigned to three groups: supervised aerobic plus stretching exercises group (group I, n:28), supervised resistance plus stretching exercises group (group II, n:28) and home-based stretching exercises group (group III, n:28). The target heart rate (HR) corresponding to values of 50-70 % ergospirometric VO2max were determined by the submaximal treadmill test. Group I was instructed walking at their target HR on a treadmill. Exercise intensity in group II was determined by one-repetition maximum (1RM) measurements. Group III was instructed to exercise at home. All participants were instructed to perform stretching exercises. Before and after a 12-week exercise program, participants were evaluated by weight, Body Mass Index (BMI), total body fat and muscle percentage, Visual Analog Scale (VAS), Fibromyalgia Impact Questionnaire (FIQ), Short Form-36 (SF-36) and Beck Depression Inventory (BDI).

Study Type: Interventional (Clinical Trial)

Eligibility criteria: Inclusion Criteria:

* Eligible participants who meet the criteria for inclusion were women with Fibromyalgia Syndrome diagnosis according to ACR 2016 Fibromyalgia Diagnostic Criteria and were 18-65 years old.
* Participants were well communicative, motivated, and willing to participate in the study.

Exclusion Criteria:

• The exclusion criteria were the presence of uncontrolled hypertension, history of myocardial infarction or coronary artery disease, unstable angina pectoris, class 3-4 heart failure (New York Heart Association), musculoskeletal or systemic diseases contradicting the exercise, a neurological or psychiatric disease affecting cooperation and cognitive function, presence of active inflammation and immunosuppression.

Primary outcomes:
measure: Change from baseline in analogue scale (VAS) score at week 12
timeFrame: Week 12
measure: Change from baseline in Fibromyalgia Impact Questionnaire (FIQ) score at week 12
timeFrame: Week 12
measure: Change from baseline Beck Depression Inventory (BDI) score (0-63) at week 12
timeFrame: Week 12
measure: Change from baseline in Short Form 36 (SF-36) score at week 12.
timeFrame: Week 12
measure: Change from baseline in weight (kilograms) at week 12.
timeFrame: Week 12
measure: Change from baseline in body mass index (BMI) at week 12
timeFrame: Week 12
measure: Change from baseline in total body fat percentage at week 12
timeFrame: Week 12
measure: Change from baseline in in total body muscle percentage at week 12.
timeFrame: Week 12
measure: Change from baseline in blood lactate concentration at rest (mmol/L) at week 12
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University Faculty of Medicine
Study officials:
affiliation: Pamukkale University
name: Fusun ARDIC, Prof.M.D.
role: STUDY_DIRECTOR
References: