Telerehabilitation Based on Aerobic Exercise in Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Telerehabilitation based on aerobic exercise
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring exercise, aerobic exercise, telerehabilitation
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
Sites / Locations
- Health Sciences Faculty, University of Valladolid
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Telerehabilitation based on aerobic exercise
Control group
Arm Description
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 that maintain the same medical treatment and not receive additional intervention.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Impact of fibromyalgia (Fibromyalgia Impact Questionnaire)
The investigators measure the impact of fibromyalgia with the Fibromyalgia Impact Questionnaire at baseline
Impact of fibromyalgia (Fibromyalgia Impact Questionnaire)
The investigators measure the impact of fibromyalgia with the Fibromyalgia Impact Questionnaire at post-intervention
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
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
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04340674
First Posted
March 27, 2020
Last Updated
October 31, 2020
Sponsor
University of Valladolid
1. Study Identification
Unique Protocol Identification Number
NCT04340674
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 6, 2020 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
October 19, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valladolid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
exercise, aerobic exercise, telerehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telerehabilitation based on aerobic exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Group that maintain the same medical treatment and not receive additional intervention.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation based on aerobic exercise
Intervention Description
To perform different whole body aerobic exercises moderately intense according to Borg scale.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
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.
Time Frame
Baseline
Title
Pain Intensity
Description
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.
Time Frame
Post-intervention, an average 15 weeks
Secondary Outcome Measure Information:
Title
Impact of fibromyalgia (Fibromyalgia Impact Questionnaire)
Description
The investigators measure the impact of fibromyalgia with the Fibromyalgia Impact Questionnaire at baseline
Time Frame
Baseline
Title
Impact of fibromyalgia (Fibromyalgia Impact Questionnaire)
Description
The investigators measure the impact of fibromyalgia with the Fibromyalgia Impact Questionnaire at post-intervention
Time Frame
Post-intervention, an average 15 weeks
Title
Mechanical pain sensitivity
Description
The investigators measure mechanical pain sensitivity of the 18 points described initially by the American College of rheumatology with an algometer at baseline
Time Frame
Baseline
Title
Pressure Pain Threshold
Description
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
Time Frame
Post-intervention, an average 15 weeks
Title
Pain Catastrophizing
Description
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.
Time Frame
Baseline
Title
Pain Catastrophizing
Description
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.
Time Frame
Post-intervention, an average 15 weeks
Title
Psychological distress
Description
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.
Time Frame
Baseline
Title
Psychological distress
Description
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.
Time Frame
Post-intervention, an average 15 weeks
Title
Upper limb function
Description
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.
Time Frame
Baseline
Title
Upper limb function
Description
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.
Time Frame
Post-intervention, an average 15 weeks
Title
Lower limb function
Description
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.
Time Frame
Baseline
Title
Lower limb function
Description
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.
Time Frame
Post-intervention, an average 15 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ignacio Hernando, PT
Organizational Affiliation
University of Valladolid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences Faculty, University of Valladolid
City
Soria
ZIP/Postal Code
42002
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The patient data were confidential and were assigned a number to each patient to maintain confidentiality
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Telerehabilitation Based on Aerobic Exercise in Fibromyalgia
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