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

NCT04426864 | Completed

• 1 other identifier: 2018TIPF044
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia Syndrome

Keywords

Fibromyalgia; Aerobic exercise; Resistance exercise; Stretching exercise

Outcome Measures

Primary Outcomes (9)

• Change from baseline in analogue scale (VAS) score at 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

  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

  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.

  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.

  Weight was measured with body composition analyzer (Tanita MC580).

  Week 12

• Change from baseline in body mass index (BMI) at 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

  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.

  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

  Finger-stick capillary whole blood was collected at rest. Blood lactate concentration was performed using a lactate analyzer (Lactate Scout Plus)

  Week 12

Study Arms (3)

Supervised Aerobic Plus Stretching Exercises Group

ACTIVE COMPARATOR

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

Supervised Resistance Plus Stretching Exercises Group

EXPERIMENTAL

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

Home-based Stretching Exercises Group

EXPERIMENTAL

The participants were instructed to perform the stretching exercises at home.

Other: Home-based Stretching Exercises Group

Interventions

Supervised Aerobic Plus Stretching Exercises OTHER

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.

Supervised Aerobic Plus Stretching Exercises Group

Supervised Resistance Plus Stretching Exercises Group OTHER

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.

Supervised Resistance Plus Stretching Exercises Group

Home-based Stretching Exercises Group OTHER

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.

Home-based Stretching Exercises Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Participant eligibility is based on the self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants were well communicative, motivated, and willing to participate in the study.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University Faculty of Medicine

Denizli, 20070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Fusun ARDIC, Prof.M.D.

  Pamukkale University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Physical Medicine and Rehabilitation, Principal Investigator, Clinical Professor

Model Details: Participants are assigned to three groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: June 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: July 1, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

TU (1)