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Comparative Study About the Effect of Aquatic Therapy vs Land-based Therapy in Women With Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Aquatic therapy
Land-based therapy
Sponsored by
Universidade da Coruña
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Pain, Postural balance, Physical therapy, Aquatic therapy

Eligibility Criteria

35 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female.
  • Age range between 35 and 64 years.
  • Diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology (ACR) in 1990 and 2010.
  • Mark ≥ 4 on the Visual Analogue Scale (VAS).
  • Mark ≥ 5 on the Visual Analogue Scale for balance included in The Revised Fibromyalgia Impact Questionnaire (FIQR).

Exclusion Criteria:

  • History of severe trauma.
  • Neurological diseases (stroke, Parkinson's disease, dementia).
  • Frequent migraines.
  • Inflammatory rheumatic diseases.
  • People who have been treated in the past six months by traumatic injuries.
  • Being pregnant.
  • Visual or hearing deficits uncorrected.
  • Infectious diseases.
  • Severe cardiovascular disease.
  • People who do exercise regularly more than 20 minutes, more than 3 times a week in the past 3 months.

Sites / Locations

  • Asociación Coruñesa de Fibromialgia, Síndrome de Fatiga Crónica y Sensibilidad Química Múltiple (ACOFIFA)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Aquatic therapy

Land-based therapy

Arm Description

Aquatic therapy is the experimental group. This therapy will take place in a warm pool which is located in Rialta's Sports Complex. Aquatic therapy session will be conducted by the main researcher with the help of an assistant. Because the number of patients (n=17), they will be subdivided into two subgroups of 8 and 9 people respectively in order to ensure the safety and care of patients. The intervention will last for one hour: Warming (15 minutes); exercises to train the static and dynamic balance (25 minutes); stretching (10 minutes); relaxation (10 minutes). Over 12 weeks of treatment, difficulty in performing exercises to train balance will increase progressively.

The description is the same as aquatic therapy. The difference is land-based therapy sessions will be made at Faculty of Physiotherapy at University of "A Coruña".

Outcomes

Primary Outcome Measures

Change from baseline Pain at 3 months of therapy and one month and a half after treatment.
Pain will be assessed using the visual analog scale (VAS).
Change from baseline Static Balance at 3 months of therapy and one month and a half after treatment.
It will be evaluated with the Romberg's test, whose execution will be filmed in slow motion and then, these videos will be analysed with a motion software.
Change from baseline Dynamic Balance at 3 months of therapy and one month and a half after treatment.
It will be assessed using the Timed Up & Go test (TUG), whose execution will be filmed in slow motion and then, these videos will be analysed with a motion software.

Secondary Outcome Measures

Change from baseline Quality of Life at 3 months of therapy and one month and a half after treatment.
It will be measured with the "Revised Fibromyalgia Impact Questionnaire" (FIQR).
Change from baseline Sleep Quality at 3 months of therapy and one month and a half after treatment.
It will be assessed with the "Pittsburgh Sleep Quality Index" (PSQI).
Change from baseline Fatigue at 3 months of therapy and one month and a half after treatment.
It will be evaluated with the "Multidimensional Fatigue Inventory" (MFI).
Change from baseline Physical Capacity at 3 months of therapy and one month and a half after treatment.
It will be measured with the "six minute walk test" (SMWT).
Change from baseline Confidence in Balance at 3 months of therapy and one month and a half after treatment.
It will be assessed with the "Activities-specific Balance Confidence" scale (ABC).
Change from baseline Pain Threshold for each one of the 18 tender points established at 3 months of therapy and one month and a half after treatment.
It will be assessed using an electronic algometer.
Change from baseline Functional Independence to perform activities of daily living at 3 months of therapy and one month and a half after treatment.
It will be assessed using the Berg Balance Scale.

Full Information

First Posted
February 18, 2016
Last Updated
May 11, 2023
Sponsor
Universidade da Coruña
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1. Study Identification

Unique Protocol Identification Number
NCT02695875
Brief Title
Comparative Study About the Effect of Aquatic Therapy vs Land-based Therapy in Women With Fibromyalgia
Official Title
Comparative Study About the Effect of a Physical Therapy Protocol in Warm Water vs Land-based Therapy in Women With Fibromyalgia Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 11, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade da Coruña

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Fibromyalgia is a disease whose incidence rate is increasing and causing a severe disability to those who suffer it. Currently, other treatment resources are being implemented, such as aquatic therapy. This therapy seems to provide positive results in different dimensions of fibromyalgia. The main objective of the study is to determine the effectiveness of a physical therapy program in warm water vs. land-based therapy in women with fibromyalgia for pain reduction and improvement balance at the end of treatment and a month and a half later (follow-up). The type of study is a randomized controlled opened trial. The sample is composed of 34 women with age between 35 and 64 years and fibromyalgia diagnosis who will be divided into 2 groups: Aquatic Therapy Group (n=17) and Land-Based Therapy Group (n=17). This study will have two primary outcomes: Pain and balance. The intensity of pain will be assessed using the visual analog scale (VAS) and the pain threshold for each one of the 18 tender points will be assessed using a electronic algometer. Static balance will be evaluated with the Romberg's test and the dynamic balance with the Timed Up & Go test (TUG) and Berg Balance Scale. Both type of balance will be recorded in slow motion and then, will be analysed with a motion software. Secondary outcomes are: The impact of fibromyalgia on patient's lives, that will be measured with the "Revised Fibromyalgia Impact Questionnaire" (FIQR); the sleep quality, that will be assessed with the "Pittsburgh Sleep Quality Index" (PSQI); the fatigue, that will be evaluated witn the "Multidimensional Fatigue Inventory" (MFI); the physical capacity, that will be measured with the "six minute walk test" (SMWT) and confidence in balance that will be assessed with the "Activities-specific Balance Confidence" scale (ABC). Each intervention will last one hour and will be made 3 times a week for three months . It will consist of 4 sections: Warming, exercises for static and dynamic balance training, stretching and relaxation. Statistical analysis will be made using the Statistical Package for the Social Sciences software, version 21.0 for Windows. p ≤ 0.05 will be the significance level set for all analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Pain, Postural balance, Physical therapy, Aquatic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aquatic therapy
Arm Type
Experimental
Arm Description
Aquatic therapy is the experimental group. This therapy will take place in a warm pool which is located in Rialta's Sports Complex. Aquatic therapy session will be conducted by the main researcher with the help of an assistant. Because the number of patients (n=17), they will be subdivided into two subgroups of 8 and 9 people respectively in order to ensure the safety and care of patients. The intervention will last for one hour: Warming (15 minutes); exercises to train the static and dynamic balance (25 minutes); stretching (10 minutes); relaxation (10 minutes). Over 12 weeks of treatment, difficulty in performing exercises to train balance will increase progressively.
Arm Title
Land-based therapy
Arm Type
Other
Arm Description
The description is the same as aquatic therapy. The difference is land-based therapy sessions will be made at Faculty of Physiotherapy at University of "A Coruña".
Intervention Type
Procedure
Intervention Name(s)
Aquatic therapy
Intervention Description
Pool material is contributed by Maria José Jove Foundation. The exercises that will be made during treatment, are designed and developed to improve "core" muscles and, in this way, improve postural balance.
Intervention Type
Procedure
Intervention Name(s)
Land-based therapy
Intervention Description
The material is contributed by Faculty of Physiotherapy at University of "A Coruña". The exercises that will be made during treatment, are designed and developed to improve "core" muscles and, in this way, improve postural balance.
Primary Outcome Measure Information:
Title
Change from baseline Pain at 3 months of therapy and one month and a half after treatment.
Description
Pain will be assessed using the visual analog scale (VAS).
Time Frame
It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
Title
Change from baseline Static Balance at 3 months of therapy and one month and a half after treatment.
Description
It will be evaluated with the Romberg's test, whose execution will be filmed in slow motion and then, these videos will be analysed with a motion software.
Time Frame
It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
Title
Change from baseline Dynamic Balance at 3 months of therapy and one month and a half after treatment.
Description
It will be assessed using the Timed Up & Go test (TUG), whose execution will be filmed in slow motion and then, these videos will be analysed with a motion software.
Time Frame
It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
Secondary Outcome Measure Information:
Title
Change from baseline Quality of Life at 3 months of therapy and one month and a half after treatment.
Description
It will be measured with the "Revised Fibromyalgia Impact Questionnaire" (FIQR).
Time Frame
It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
Title
Change from baseline Sleep Quality at 3 months of therapy and one month and a half after treatment.
Description
It will be assessed with the "Pittsburgh Sleep Quality Index" (PSQI).
Time Frame
It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
Title
Change from baseline Fatigue at 3 months of therapy and one month and a half after treatment.
Description
It will be evaluated with the "Multidimensional Fatigue Inventory" (MFI).
Time Frame
It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
Title
Change from baseline Physical Capacity at 3 months of therapy and one month and a half after treatment.
Description
It will be measured with the "six minute walk test" (SMWT).
Time Frame
It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
Title
Change from baseline Confidence in Balance at 3 months of therapy and one month and a half after treatment.
Description
It will be assessed with the "Activities-specific Balance Confidence" scale (ABC).
Time Frame
It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
Title
Change from baseline Pain Threshold for each one of the 18 tender points established at 3 months of therapy and one month and a half after treatment.
Description
It will be assessed using an electronic algometer.
Time Frame
It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).
Title
Change from baseline Functional Independence to perform activities of daily living at 3 months of therapy and one month and a half after treatment.
Description
It will be assessed using the Berg Balance Scale.
Time Frame
It will be measured at baseline, at 3 months of therapy and one month and a half after treatment (follow-up).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female. Age range between 35 and 64 years. Diagnosis of fibromyalgia according to the criteria of the American College of Rheumatology (ACR) in 1990 and 2010. Mark ≥ 4 on the Visual Analogue Scale (VAS). Mark ≥ 5 on the Visual Analogue Scale for balance included in The Revised Fibromyalgia Impact Questionnaire (FIQR). Exclusion Criteria: History of severe trauma. Neurological diseases (stroke, Parkinson's disease, dementia). Frequent migraines. Inflammatory rheumatic diseases. People who have been treated in the past six months by traumatic injuries. Being pregnant. Visual or hearing deficits uncorrected. Infectious diseases. Severe cardiovascular disease. People who do exercise regularly more than 20 minutes, more than 3 times a week in the past 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabela Rivas Neira, Physiotherapy
Organizational Affiliation
Facultade de Fisioterapia da Universidade da Coruña
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jamile Vivas Costa, Physiotherapy
Organizational Affiliation
Facultade de Fisioterapia da Universidade da Coruña
Official's Role
Study Director
Facility Information:
Facility Name
Asociación Coruñesa de Fibromialgia, Síndrome de Fatiga Crónica y Sensibilidad Química Múltiple (ACOFIFA)
City
A Coruña
ZIP/Postal Code
15006
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28103853
Citation
Rivas Neira S, Pasqual Marques A, Pegito Perez I, Fernandez Cervantes R, Vivas Costa J. Effectiveness of Aquatic Therapy vs Land-based Therapy for Balance and Pain in Women with Fibromyalgia: a study protocol for a randomised controlled trial. BMC Musculoskelet Disord. 2017 Jan 19;18(1):22. doi: 10.1186/s12891-016-1364-5.
Results Reference
derived

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Comparative Study About the Effect of Aquatic Therapy vs Land-based Therapy in Women With Fibromyalgia

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