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Completed

NCT Number: NCT04340674

Telerehabilitation Based on Aerobic Exercise in 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.

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Key information

Conditions

Fibromyalgia Behavior Motor Activity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

30 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences Faculty, University of Valladolid

Soria, 42002, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telerehabilitation based on aerobic exercise

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Impact of fibromyalgia (Fibromyalgia Impact Questionnaire)

    Time frame: Baseline

    The investigators measure the impact of fibromyalgia with the Fibromyalgia Impact Questionnaire at baseline

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

University of Valladolid

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 9, 2020
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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