Telerehabilitation Based on Aerobic Exercise in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04340674
• Other study ID #: UValladolid
• Status: Completed
• Phase: N/A
• Start date: February 6, 2020
• Est. completion date: October 19, 2020

Study information

• Verified date: October 2020
• Source: University of Valladolid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 19, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Telerehabilitation based on aerobic exercise
To perform different whole body aerobic exercises moderately intense according to Borg scale.

Locations

Country	Name	City	State
Spain	Health Sciences Faculty, University of Valladolid	Soria

Sponsors (1)

Lead Sponsor	Collaborator
University of Valladolid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Impact of fibromyalgia (Fibromyalgia Impact Questionnaire)	The investigators measure the impact of fibromyalgia with the Fibromyalgia Impact Questionnaire at baseline	Baseline
Secondary	Impact of fibromyalgia (Fibromyalgia Impact Questionnaire)	The investigators measure the impact of fibromyalgia with the Fibromyalgia Impact Questionnaire at post-intervention	Post-intervention, an average 15 weeks
Secondary	Mechanical pain sensitivity	The investigators measure mechanical pain sensitivity of the 18 points described initially by the American College of rheumatology with an algometer at baseline	Baseline
Secondary	Pressure Pain Threshold	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
Secondary	Pain Catastrophizing	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
Secondary	Pain Catastrophizing	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
Secondary	Psychological distress	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
Secondary	Psychological distress	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
Secondary	Upper limb function	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
Secondary	Upper limb function	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
Secondary	Lower limb function	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
Secondary	Lower limb function	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