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Telerehabilitation Based on Aerobic Exercise in Fibromyalgia

NCT ID: NCT04340674

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-06

Study Completion Date

2020-10-19

Brief Summary

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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.

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Telerehabilitation based on aerobic exercise

Intervention Type OTHER

To perform different whole body aerobic exercises moderately intense according to Borg scale.

Control group

Group that maintain the same medical treatment and not receive additional intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telerehabilitation based on aerobic exercise

To perform different whole body aerobic exercises moderately intense according to Borg scale.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Valladolid

OTHER

Sponsor Role lead

Responsible Party

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Ignacio Hernando Garijo

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ignacio Hernando, PT

Role: PRINCIPAL_INVESTIGATOR

University of Valladolid

Locations

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Health Sciences Faculty, University of Valladolid

Soria, , Spain

Site Status

Countries

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Spain

Other Identifiers

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UValladolid

Identifier Type: -

Identifier Source: org_study_id