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

NCT ID: NCT04426864

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2020-07-01

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)

Conditions

Fibromyalgia Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Supervised Aerobic Plus Stretching Exercises

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Supervised Resistance Plus Stretching Exercises Group

Intervention Type: 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.

Home-based Stretching Exercises Group

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

Group Type: EXPERIMENTAL

Home-based Stretching Exercises Group

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Füsun Ardıç

Director, Head of Physical Medicine and Rehabilitation, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fusun ARDIC, Prof.M.D.

Role: STUDY_DIRECTOR

Pamukkale University

Locations

Pamukkale University Faculty of Medicine

Denizli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2018TIPF044

Identifier Type: -

Identifier Source: org_study_id