FibromyalgiaNCT04340674
Telerehabilitation Based on Aerobic Exercise in Fibromyalgia
A study testing Telerehabilitation based on aerobic exercise in people with Fibromyalgia, run by University of Valladolid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Telerehabilitation based on aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 6 Feb 2020to 19 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any kind of contraindications for physical activity
- Other physical or psychological therapies in the last 3 months.
- Medication modifications in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effects of a Telerehabilitation Program Based on Aerobic Exercise in Women With 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.
Read more
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
- Being tested
- Telerehabilitation based on aerobic exercise
- Keywords
- exercise, aerobic exercise, telerehabilitation
- Medical subject headings
- Fibromyalgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation based on aerobic exerciseOther
To perform different whole body aerobic exercises moderately intense according to Borg scale.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Telerehabilitation based on aerobic exercise |
| Control group | No intervention | Group that maintain the same medical treatment and not receive additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Post-intervention, an average 15 weeks
Secondary outcomes (12)
Impact of fibromyalgia (Fibromyalgia Impact Questionnaire)
The investigators measure the impact of fibromyalgia with the Fibromyalgia Impact Questionnaire at baseline
Measured: Baseline
Impact of fibromyalgia (Fibromyalgia Impact Questionnaire)
The investigators measure the impact of fibromyalgia with the Fibromyalgia Impact Questionnaire at post-intervention
Measured: Post-intervention, an average 15 weeks
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
Measured: 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
Measured: Post-intervention, an average 15 weeks
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.
Measured: Baseline
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.
Measured: Post-intervention, an average 15 weeks
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.
Measured: Baseline
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.
Measured: Post-intervention, an average 15 weeks
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.
Measured: Baseline
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.
Measured: Post-intervention, an average 15 weeks
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.
Measured: Baseline
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.
Measured: Post-intervention, an average 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start6 Feb 2020
- Primary completion15 Sep 2020
- Study completion19 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio Hernando Garijo, University of Valladolid
- Investigators
- Ignacio Hernando, PT, Principal investigator, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340674
- Sponsor's protocol ID
- UValladolid
- Status last verified
- Oct 2020
- First submitted
- 27 Mar 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The patient data were confidential and were assigned a number to each patient to maintain confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of a Telerehabilitation Program Based on Aerobic Exercise in Women With Fibromyalgia
- ClinicalTrials.gov ID
- NCT04340674
- Acronym / sponsor ID
- UValladolid
- Conditions
- Fibromyalgia
- Keywords
- exercise, aerobic exercise, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 19 Oct 2020 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation based on aerobic exercise | Experimental | Other: Telerehabilitation based on aerobic exerciseAerobic 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. |
| Control group | No intervention | –Group that maintain the same medical treatment and not receive additional intervention. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Any kind of contraindications for physical activity
- Other physical or psychological therapies in the last 3 months.
- Medication modifications in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telerehabilitation based on aerobic exerciseTo perform different whole body aerobic exercises moderately intense according to Borg scale. | Other | Telerehabilitation based on aerobic exercise |
Primary outcome
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.
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.
12 secondary outcomes
Impact of fibromyalgia (Fibromyalgia Impact Questionnaire)
Time frame: Baseline
Impact of fibromyalgia (Fibromyalgia Impact Questionnaire)
Time frame: Post-intervention, an average 15 weeks
Mechanical pain sensitivity
Time frame: Baseline
Pressure Pain Threshold
Time frame: Post-intervention, an average 15 weeks
Pain Catastrophizing
Time frame: Baseline
Pain Catastrophizing
Time frame: Post-intervention, an average 15 weeks
Psychological distress
Time frame: Baseline
Psychological distress
Time frame: Post-intervention, an average 15 weeks
Upper limb function
Time frame: Baseline
Upper limb function
Time frame: Post-intervention, an average 15 weeks
Lower limb function
Time frame: Baseline
Lower limb function
Time frame: Post-intervention, an average 15 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: No. The patient data were confidential and were assigned a number to each patient to maintain confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignacio Hernando, PT principal investigator
University of Valladolid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation based on aerobic exercise in people with Fibromyalgia, run by University of Valladolid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.