Clinical trial NCT04340674: Telerehabilitation Based on Aerobic Exercise in Fibromyalgia
Official title: Immediate Effects of a Telerehabilitation Program Based on Aerobic Exercise in Women With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: exercise
aerobic exercise
telerehabilitation
Lead sponsor: University of Valladolid
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 34
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain Intensity
timeFrame: Baseline
measure: Pain Intensity
timeFrame: Post-intervention, an average 15 weeks
Secondary outcomes:
measure: Impact of fibromyalgia (Fibromyalgia Impact Questionnaire)
timeFrame: Baseline
measure: Impact of fibromyalgia (Fibromyalgia Impact Questionnaire)
timeFrame: Post-intervention, an average 15 weeks
measure: Mechanical pain sensitivity
timeFrame: Baseline
measure: Pressure Pain Threshold
timeFrame: Post-intervention, an average 15 weeks
measure: Pain Catastrophizing
timeFrame: Baseline
measure: Pain Catastrophizing
timeFrame: Post-intervention, an average 15 weeks
measure: Psychological distress
timeFrame: Baseline
measure: Psychological distress
timeFrame: Post-intervention, an average 15 weeks
measure: Upper limb function
timeFrame: Baseline
measure: Upper limb function
timeFrame: Post-intervention, an average 15 weeks
measure: Lower limb function
timeFrame: Baseline
measure: Lower limb function
timeFrame: Post-intervention, an average 15 weeks
Other outcomes:
Locations:
city: Soria
country: Spain
facility: Health Sciences Faculty, University of Valladolid
Study officials:
affiliation: University of Valladolid
name: Ignacio Hernando, PT
role: PRINCIPAL_INVESTIGATOR
References: