Telerehabilitation Based on Aerobic Exercise in Fibromyalgia

October 31, 2020 updated by: Ignacio Hernando Garijo, University of Valladolid

Immediate Effects of a Telerehabilitation Program Based on Aerobic Exercise in Women With Fibromyalgia

Fibromyalgia syndrome is the most common cause of chronic generalized musculoskeletal pain and is characterized by pain associated with generalizad sensitivity, fatigue, sleep disturbances and psychological problems. Due to the chronic nature of the pathology and the great dependence on analgesic drugs that it often entails, in these patients it is considered necessary to provide an individualized approach and provide strategies that allow symptoms to be controlled conservatively and non-pharmacologically.

The objective of this trial is to analyse the immediate effects on pain, mechanical pain sensitivity, impact of fibromyalgia, pain catastrophizing, psychological distress and physical function when a telerehabilitation program based on aerobic exercise is applied in women with fibromyalgia.

For this purpose the investigators conduct a randomized controlled trial single-blind (examiner). The investigators included female patients diagnosed of fibromyalgia according to the American College of Rheumatology (ACR).

Thirty-four women with fibromyalgia are included and randomized into 2 groups: telerehabilitation program group based on aerobic exercise and control group. Exercise group receive 2 treatment sessions a week over 15 weeks.

All the variables are measured at the beginning of intervention and after the intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Soria, Spain, 42002
        • Health Sciences Faculty, University of Valladolid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women diagnosed medically with Fibromyalgia
  • Diagnosed according to the American College of Rheumatology criteria
  • Age between 30 and 75 years old
  • Telerehabilitation equipment including a laptop computer and access to internet

Exclusion Criteria:

  • Any kind of contraindications for physical activity
  • Other physical or psychological therapies in the last 3 months.
  • Medication modifications in the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Telerehabilitation based on aerobic exercise
Aerobic low-impact exercise guided by audiovisual material. The intensity of exercise is adapted to each participant and is established according to the perceived effort after each session, according to the modified Borg perceived effort scale.
Other: Telerehabilitation based on aerobic exercise
To perform different whole body aerobic exercises moderately intense according to Borg scale.
NO_INTERVENTION: Control group
Group that maintain the same medical treatment and not receive additional intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: Baseline
The investigators measure the intensity of pain with a Visual Analogic Scale at baseline. The scale score ranges from 0 to 100 and higher scores indicate greater pain intensity.
Baseline
Pain Intensity
Time Frame: Post-intervention, an average 15 weeks
The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) at the end of the intervention. The scale score ranges from 0 to 100 and higher scores indicate greater pain intensity.
Post-intervention, an average 15 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of fibromyalgia (Fibromyalgia Impact Questionnaire)
Time Frame: Baseline
The investigators measure the impact of fibromyalgia with the Fibromyalgia Impact Questionnaire at baseline
Baseline
Impact of fibromyalgia (Fibromyalgia Impact Questionnaire)
Time Frame: Post-intervention, an average 15 weeks
The investigators measure the impact of fibromyalgia with the Fibromyalgia Impact Questionnaire at post-intervention
Post-intervention, an average 15 weeks
Mechanical pain sensitivity
Time Frame: Baseline
The investigators measure mechanical pain sensitivity of the 18 points described initially by the American College of rheumatology with an algometer at baseline
Baseline
Pressure Pain Threshold
Time Frame: Post-intervention, an average 15 weeks
The investigators measure mechanical pain sensitivity of the 18 points described initially by the American College of rheumatology with an algometer at the end of treatment
Post-intervention, an average 15 weeks
Pain Catastrophizing
Time Frame: Baseline
The investigators measure the pain catastrophizing with the Pain Catastrophizing Scale at baseline. Total values range from 0 to 52 points. Higher values indicate a higher level of pain catastrophizing.
Baseline
Pain Catastrophizing
Time Frame: Post-intervention, an average 15 weeks
The investigators measure the pain catastrophizing with the Pain Catastrophizing Scale at post-intervention. Total values range from 0 to 52 points. Higher values indicate a higher level of pain catastrophizing.
Post-intervention, an average 15 weeks
Psychological distress
Time Frame: Baseline
The investigators measure psychological distress levels with the Hospital Anxiety and Depression Scale at baseline.The questionnaire consists of two subscales and each subscale has a total score of 21 points. Higher scores represent higher levels of anxiety.
Baseline
Psychological distress
Time Frame: Post-intervention, an average 15 weeks
The investigators measure psychological distress levels with the Hospital Anxiety and Depression Scale (HADS) at post-intervention. The questionnaire consists of two subscales and each subscale has a total score of 21 points. Higher scores represent higher levels of anxiety.
Post-intervention, an average 15 weeks
Upper limb function
Time Frame: Baseline
The investigators measure upper limb functional capacity with the the Arm Curl Test at baseline. The number of repetitions that the participant can flex and re-extend the elbow holding a weight in 30 seconds is recorded.
Baseline
Upper limb function
Time Frame: Post-intervention, an average 15 weeks
The investigators measure upper limb functional capacity with the Arm Curl Test at post-intervention. The number of repetitions that the participant can flex and re-extend the elbow holding a weight in 30 seconds is recorded.
Post-intervention, an average 15 weeks
Lower limb function
Time Frame: Baseline
The investigators measure lower limb functional capacity with the 6-Minute Walk Test at baseline. The distance (meters) that the patient can walk in 6 minutes is recorded.
Baseline
Lower limb function
Time Frame: Post-intervention, an average 15 weeks
The investigators measure lower limb functional capacity with the 6-Minute Walk Test at post-intervention. The distance (meters) that the patient can walk in 6 minutes is recorded.
Post-intervention, an average 15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valladolid

Investigators

  • Principal Investigator: Ignacio Hernando, PT, University of Valladolid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 6, 2020

Primary Completion (ACTUAL)

September 15, 2020

Study Completion (ACTUAL)

October 19, 2020

Study Registration Dates

First Submitted

March 27, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (ACTUAL)

April 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 3, 2020

Last Update Submitted That Met QC Criteria

October 31, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UValladolid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The patient data were confidential and were assigned a number to each patient to maintain confidentiality

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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