Telerehabilitation Based on Aerobic Exercise in Fibromyalgia

NCT04340674 | Completed

• 1 other identifier: UValladolid
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia

Keywords

exercise; aerobic exercise; telerehabilitation

Outcome Measures

Primary Outcomes (2)

• Pain Intensity

  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

  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 Outcomes (12)

• Impact of fibromyalgia (Fibromyalgia Impact Questionnaire)

  Baseline

• Impact of fibromyalgia (Fibromyalgia Impact Questionnaire)

  Post-intervention, an average 15 weeks

• Mechanical pain sensitivity

  Baseline

• Pressure Pain Threshold

  Post-intervention, an average 15 weeks

• Pain Catastrophizing

  Baseline

Study Arms (2)

Telerehabilitation based on aerobic exercise

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Telerehabilitation based on aerobic exercise OTHER

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

Telerehabilitation based on aerobic exercise

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Valladolid: lead

Study Sites (1)

Health Sciences Faculty, University of Valladolid

Soria, 42002, Spain

Location

MeSH Terms

Conditions

Fibromyalgia; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Study Officials

• Ignacio Hernando, PT

  University of Valladolid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: April 9, 2020
• Study Start: February 6, 2020
• Primary Completion: September 15, 2020
• Study Completion: October 19, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)