Efficacy of Different Types of Exercises in Women With Fibromyalgia Syndrome.

September 14, 2020 updated by: Füsun Ardıç, Pamukkale University

Efficacy of Different Types of Exercises on Pain, Quality of Life, Depression, and Body Composition in Women With Fibromyalgia Syndrome.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Denizli, Turkey, 20070
        • Pamukkale University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Supervised Aerobic Plus Stretching Exercises Group
The participants were instructed to perform the walking exercise at their target HR on a treadmill and stretching exercises before and after the exercise program in the Sports Rehabilitation Unit of Pamukkale University.
Other: Supervised Aerobic Plus Stretching Exercises
An exercise prescription was developed for each woman based on the data acquired from the baseline treadmill exercise test. Target HR corresponding to values of 50-70 % ergospirometric VO2max (moderate-intensity) was determined by the submaximal treadmill test. The participants were instructed to perform their exercises at 50 % of VO2max for six weeks. At seventh their exercise intensity was increased to target HR corresponding to 70 % of VO2max. HR was monitored by a Polar HR monitor (Polar Beat, Port Washington, NY). Stretching exercises were performed at the beginning and end of each exercise session. Each muscle group exercise was performed 3-4 times and each repeat was 30 seconds long. The muscle groups which were involved in stretching exercises were upper trapezius, rhomboid, hip flexor, hamstring, pectoral, piriformis, quadriceps, gastrocnemius, soleus, levator scapulae, hip adductor and tensor fasciae late muscles. The exercise program was applied 3 days a week for 12 weeks.
EXPERIMENTAL: Supervised Resistance Plus Stretching Exercises Group
The participants were instructed to perform resistance exercises using weight machines and stretching exercises before and after the exercise program in the Sports Rehabilitation Unit of Pamukkale University.
Other: Supervised Resistance Plus Stretching Exercises Group
According to the data obtained from 1-RM tests, an exercise prescription was developed for each woman. The participants were instructed to perform their exercises with 50% of 1-RM for six weeks. In the 7. week, weights were increased to 70-80% of 1-RM. The number of sets increased progressively (10 repetitions per set; 1 set in the first two weeks; 2 sets in the 3rd and 4th week; 3 sets in the 5th and 6th week). The muscle groups which were involved in resistance exercises were bilateral biceps, deltoid, trapezius, pectorals, serratus anterior, latissimus dorsi, levator scapulae, rhomboid, gluteal, quadriceps, hip adductor and abductor, hamstring, gastrocnemius and abdominal muscles. Stretching exercises were performed at the beginning and end of each exercise session. Each muscle group exercise was performed 3-4 times and each repeat was 30 seconds long. Stretching exercises were given for the muscle groups they worked on. The exercise program was applied 3 days a week for 12 weeks.
EXPERIMENTAL: Home-based Stretching Exercises Group
The participants were instructed to perform the stretching exercises at home.
Other: Home-based Stretching Exercises Group
Each exercise was described to the patient by visually. For each muscle group exercise was performed for 3-4 times and each repeat was 30 seconds long. The muscle groups which were involved in stretching exercises were upper trapezius, rhomboid, hip flexor, hamstring, pectoral, piriformis, quadriceps, gastrocnemius, soleus, levator scapulae, hip adductor and tensor fasciae late muscles. Exercise program was applied 3 days in a week during 12 weeks. Each participant was called every 2 weeks to maintain compliance.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in analogue scale (VAS) score at week 12
Time Frame: Week 12
Pain intensity was measured with VAS for pain (0-10 cm; 0: no pain, 10: severe pain).
Week 12
Change from baseline in Fibromyalgia Impact Questionnaire (FIQ) score at week 12
Time Frame: Week 12
The Fibromyalgia Impact Questionnaire was designed to measure the health status of patients with fibromyalgia. Total score range from 0 to 100, with higher scores indicating higher levels of symptoms and severity.
Week 12
Change from baseline Beck Depression Inventory (BDI) score (0-63) at week 12
Time Frame: Week 12
This is a 21-item questionnaire that investigates the symptoms of depression. Total score range from 0 to 63, higher scores indicate higher levels of depression.
Week 12
Change from baseline in Short Form 36 (SF-36) score at week 12.
Time Frame: Week 12
Short- form health survey 36 contains 36 items which are used to evaluate the quality of life of patients. It measures eight different domains that address physical functioning, physical role limitation, body pain, general health, vitality, social functioning, emotional role limitation and mental health. The score of each domain ranges from 0 (worse quality of life) to 100 (best quality of life).
Week 12
Change from baseline in weight (kilograms) at week 12.
Time Frame: Week 12
Weight was measured with body composition analyzer (Tanita MC580).
Week 12
Change from baseline in body mass index (BMI) at week 12
Time Frame: Week 12
Height was measured with stadiometer and BMI was calculated with body composition analyzer (Tanita MC580).
Week 12
Change from baseline in total body fat percentage at week 12
Time Frame: Week 12
Total body fat percentage was measured with body composition analyzer (Tanita MC580).
Week 12
Change from baseline in in total body muscle percentage at week 12.
Time Frame: Week 12
Total body muscle percentage was measured with body composition analyzer (Tanita MC580).
Week 12
Change from baseline in blood lactate concentration at rest (mmol/L) at week 12
Time Frame: Week 12
Finger-stick capillary whole blood was collected at rest. Blood lactate concentration was performed using a lactate analyzer (Lactate Scout Plus)
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pamukkale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Fusun ARDIC, Prof.M.D., Pamukkale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018TIPF044

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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