Back to resultsStrength Training in Fibromyalgia on Balance, Neuromuscular Performance and Symptoms
Primary Purpose
Fibromyalgia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Strength exercise
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise
Control
Arm Description
8 weeks of strength training.
Maintain their usual medical treatment and daily routines
Outcomes
Primary Outcome Measures
Balance
Force plate
Balance
Force plate
Balance
Force plate
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05646641
First Posted
November 29, 2022
Last Updated
December 14, 2022
Sponsor
University of Beira Interior
1. Study Identification
Unique Protocol Identification Number
NCT05646641
Brief Title
Strength Training in Fibromyalgia on Balance, Neuromuscular Performance and Symptoms
Official Title
Does Strength Training in Fibromyalgia Affect Balance, Neuromuscular Performance and Symptoms? A 12 Week of a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Beira Interior
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is verify the effects of a 8 weeks strength training, on balance, neuromuscular performance and symptomatology of fibromyalgia.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
8 weeks of strength training.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Maintain their usual medical treatment and daily routines
Intervention Type
Other
Intervention Name(s)
Strength exercise
Intervention Description
The protocol consists of 8 weeks of training, consisting of 16 sessions of 50 minutes, twice a week on alternate days.
Primary Outcome Measure Information:
Title
Balance
Description
Force plate
Time Frame
Change from Baseline balance at week 9
Title
Balance
Description
Force plate
Time Frame
Change from Baseline balance at week 12
Title
Balance
Description
Force plate
Time Frame
Change from week 9 balance at week 12
Title
Neuromuscular performance
Description
Optical measurement system consisting of two transmitting and receiving cells to assess vertical jump and medicine ball to assess strength of the upper limbs.
Time Frame
Change from Baseline neuromuscular performance at week 9
Title
Neuromuscular performance
Description
Optical measurement system consisting of two transmitting and receiving cells to assess vertical jump and medicine ball to assess strength of the upper limbs.
Time Frame
Change from Baseline neuromuscular performance at week 12
Title
Neuromuscular performance
Description
Optical measurement system consisting of two transmitting and receiving cells to assess vertical jump and medicine ball to assess strength of the upper limbs.
Time Frame
Change from week 9 neuromuscular performance at week 12
Secondary Outcome Measure Information:
Title
Fibromyalgia impact questionnaire
Description
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.
Time Frame
Baseline, week 9, week 12
Title
Pain intensity
Description
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.
Time Frame
baseline and everyday until the week 12
Title
Anxiety
Description
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.
Time Frame
baseline and everyday until the week 12
Title
Quality of sleep
Description
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.
Time Frame
baseline and everyday until the week 12
Title
Fatigue
Description
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.
Time Frame
baseline and everyday until the week 12
Title
Mood state
Description
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.
Time Frame
baseline and everyday until the week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Coordinator
Phone
+351910308992
Email
luiza.albuquerque@ubi.pt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Investigator
Organizational Affiliation
University of Beira Interior
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Strength Training in Fibromyalgia on Balance, Neuromuscular Performance and Symptoms
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