Strength Training in Fibromyalgia on Balance, Neuromuscular Performance and Symptoms

Fibromyalgia Clinical Trial

Official title:

Does Strength Training in Fibromyalgia Affect Balance, Neuromuscular Performance and Symptoms? A 12 Week of a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05646641
• Other study ID #: D2834
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: January 2025

Study information

• Verified date: November 2023
• Source: University of Beira Interior
• Contact: Coordinator
• Phone: +351910308992
• Email: luiza.albuquerque[@]ubi.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is verify the effects of a 8 weeks strength training, on balance, neuromuscular performance and symptomatology of fibromyalgia.

Description:

Thirty participants will be recruited. Volunteers will be randomly assigned to the control group or experimental group. Before the training period, symptoms, balance and neuromuscular performance will be assessed. Participants in the experimental group will perform strength training twice a week (50 min each) for eight weeks. Then, four weeks of detraining will be completed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• medical diagnosis of fibromyalgia according to the American College of Rheumatology criteria

• at least 18 years old

Exclusion Criteria:

• severe comorbidity or any other type of condition that negatively influences participation in the training program

• cognitive disorders

• heart problems

• surgeries or fractures in the last 6 months

• regular practice of physical exercises in the least 3 months before program.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Strength exercise
The protocol consists of 8 weeks of training, consisting of 16 sessions of 50 minutes, twice a week on alternate days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Beira Interior

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Balance	Force plate	Change from Baseline balance at week 9
Primary	Balance	Force plate	Change from Baseline balance at week 12
Primary	Balance	Force plate	Change from week 9 balance at week 12
Primary	Neuromuscular performance	Optical measurement system consisting of two transmitting and receiving cells to assess vertical jump and medicine ball to assess strength of the upper limbs.	Change from Baseline neuromuscular performance at week 9
Primary	Neuromuscular performance	Optical measurement system consisting of two transmitting and receiving cells to assess vertical jump and medicine ball to assess strength of the upper limbs.	Change from Baseline neuromuscular performance at week 12
Primary	Neuromuscular performance	Optical measurement system consisting of two transmitting and receiving cells to assess vertical jump and medicine ball to assess strength of the upper limbs.	Change from week 9 neuromuscular performance at week 12
Secondary	Fibromyalgia impact questionnaire	Questionnaire to ccess information on the functional capacity and health status of individuals with fibromyalgia. Composed of 20 questions. , the values vary from 0 to 100, in which the higher the value, the greater the impact of fibromyalgia.	Baseline, week 9, week 12
Secondary	Pain intensity	Visual Analogue Scale (VAS). The scoring range will be from 0 to 100, in which the higher the value, the greater the intensity. During non-presencial days, participants will respond daily the intensity with a cell phone application developed for this purpose.	baseline and everyday until the week 12
Secondary	Anxiety	Visual Analogue Scale (VAS). The scoring range will be from 0 to 100, in which the higher the value, the greater the intensity. During non-presencial days, participants will respond daily the intensity with a cell phone application developed for this purpose.	baseline and everyday until the week 12
Secondary	Quality of sleep	Visual Analogue Scale (VAS). The scoring range will be from 0 to 100, in which the higher the value, the greater the intensity. During non-presencial days, participants will respond daily the intensity with a cell phone application developed for this purpose.	baseline and everyday until the week 12
Secondary	Fatigue	Visual Analogue Scale (VAS). The scoring range will be from 0 to 100, in which the higher the value, the greater the intensity. During non-presencial days, participants will respond daily the intensity with a cell phone application developed for this purpose.	baseline and everyday until the week 12
Secondary	Mood state	Visual Analogue Scale (VAS). The scoring range will be from 0 to 100, in which the higher the value, the greater the intensity. During non-presencial days, participants will respond daily the intensity with a cell phone application developed for this purpose.	baseline and everyday until the week 12