Strength Training in Fibromyalgia on Balance, Neuromuscular Performance and Symptoms

Sponsor
University of Beira Interior (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05646641
Collaborator
(none)
30
2
7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Strength exercise
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Does Strength Training in Fibromyalgia Affect Balance, Neuromuscular Performance and Symptoms? A 12 Week of a Randomized Controlled Trial
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Exercise

8 weeks of strength training.

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

No Intervention: Control

Maintain their usual medical treatment and daily routines

Outcome Measures

Primary Outcome Measures

  1. Balance [Change from Baseline balance at week 9]

    Force plate

  2. Balance [Change from Baseline balance at week 12]

    Force plate

  3. Balance [Change from week 9 balance at week 12]

    Force plate

  4. Neuromuscular performance [Change from Baseline neuromuscular performance at week 9]

    Optical measurement system consisting of two transmitting and receiving cells to assess vertical jump and medicine ball to assess strength of the upper limbs.

  5. Neuromuscular performance [Change from Baseline neuromuscular performance at week 12]

    Optical measurement system consisting of two transmitting and receiving cells to assess vertical jump and medicine ball to assess strength of the upper limbs.

  6. Neuromuscular performance [Change from week 9 neuromuscular performance at week 12]

    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

  1. Fibromyalgia impact questionnaire [Baseline, week 9, week 12]

    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.

  2. Pain intensity [baseline and everyday until the week 12]

    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.

  3. Anxiety [baseline and everyday until the week 12]

    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.

  4. Quality of sleep [baseline and everyday until the week 12]

    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.

  5. Fatigue [baseline and everyday until the week 12]

    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.

  6. Mood state [baseline and everyday until the week 12]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Beira Interior

Investigators

  • Study Director: Investigator, University of Beira Interior

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maria Luiza Laurentino de Albuquerque, Principal Investigator, University of Beira Interior
ClinicalTrials.gov Identifier:
NCT05646641
Other Study ID Numbers:
  • D2834
First Posted:
Dec 12, 2022
Last Update Posted:
Dec 19, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 19, 2022