Back to resultsProgram of Supervised Occlusive Aerobic Training in People With Fibromyalgia.
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Occlusion training
Sponsored by
About this trial
This is an interventional supportive care trial for Fibromyalgia focused on measuring occlusive training
Eligibility Criteria
Inclusion Criteria: A patient meets diagnostic criteria for fibromyalgia if the following three conditions are present: (American Rheumatology Association). Wolfe et al., (2010). o 1) Widespread Pain Index (WPI) ≥ 7 and Symptom Severity Score (SS Score) ≥ 5 or WPI 3-6 and SS ≥ 9. Symptoms have been present, at a similar level, during the last three months. The patient has no other pathology that could explain the pain. Recent negative COVID-19 test. Exclusion Criteria: Other associated pathologies that may hinder the development of the research. Mobility limitations. Injuries that add to those of the disease itself and hinder mobility. No medical evaluation of the diagnosis of the disease. Negative results in the inclusion tests. Cardiac pathologies. Blood pressure higher than 130-90 mmHg. No COVID-19 test.
Sites / Locations
- Universidad Pablo de Olavide
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group 1: Aerobic exercise plus occlusive tool.
Group 2: Aerobic exercise without occlusive tool.
Arm Description
Performing low-impact aerobic exercise with an occlusive tool 2 days per week.
Performing low-impact aerobic exercise without an occlusive tool 2 days per week.
Outcomes
Primary Outcome Measures
Change in Coenzyme Q10 after a 9-week intervention period.
Coenzyme Q10
Change in total antioxidants after a 9-week intervention period.
TAS
Change in disease impact questionnaire WPI after a 9-week intervention period.
WPI; score between (0-19). The higher the score, the greater the impact of the disease.
Change in disease impact questionnaire SSscore after a 9-week intervention period.
SS score; score between (0-3) in the first half. Score between (0-40); between 1-10 (1 point), between 11-24 (2 points), more than 25 (3 points) in the second half. The higher the score, the greater the impact of the disease.
Change in disease impact questionnaire FIQ after a 9-week intervention period.
FIQ; score between (0-100). The higher the score, the greater the impact of the disease
Change in disease impact questionnaire MFI-20 after a 9-week intervention period.
MFI-20; (0-60) no fatigue. (60-70), fatigue, lighter or more severe, depending on the depending on the rating closer to 60 or 70 points. (more than 70 points), severe fatigue.
Change in high density lipoproteins after a 9-week intervention period.
HDL
Change in low density lipoproteins after a 9-week intervention period.
LDL
Change in total cholesterol lipoproteins after a 9-week intervention period.
CHOL
Change in triglycerides after a 9-week intervention period.
TG
Changes in urea after a 9-week intervention period.
Urea
Changes in creatinine after a 9-week intervention period.
Creatinine
Change in gamma-glutamyl transferase after a 9-week intervention period.
GGT
Change in glutamic-pyruvic transaminase after a 9-week intervention period.
GPT
Change in glutamic oxaloacetic acid transaminase after a 9-week intervention period.
GOT
Change in alkaline phosphatase after a 9-week intervention period.
ALP
Change in funcional test after a 9-week intervention period.
6-minute walking test
Change in funcional test after a 9-week intervention period.
incremental shuttle walking test
Change in funcional test after a 9-week intervention period.
30 second chair and stand test
Change in funcional test after a 9-week intervention period.
Time and go test
Change in malondialdehyde after a 9-week intervention period.
MDA (malondialdehyde)
Change in distance traveled after a 9-week intervention period.
Pedometer registration. Immediately after each session from week 1 to 9 of the intervention period. With a total of 18 recordings over the 9 weeks of the intervention period.
Change in visual pain scale VAS over a 9-week intervention period.
Visual pain scale (1-10). 1 being lighter and 10 being more severe. Visual pain scale recording. Before and immediately after each session from week 1 to week 9 of the intervention period. With a total of 36 recordings during the 9 weeks of the intervention period.
Change in perceived exertion scale BORG over a 9-week intervention period.
Perceived exertion scale. (1-10). 1 being lighter and 10 being more severe. Perceived exertion scale recording. Before and immediately after each session from week 1 to week 9 of the intervention period. With a total of 36 recordings during the 9 weeks of the intervention period.
Secondary Outcome Measures
Full Information
NCT ID
NCT06001034
First Posted
July 6, 2023
Last Updated
August 13, 2023
Sponsor
José Carlos Rodríguez Bautista
Collaborators
Universidad Pablo de Olavide, Hospital Universitario de Valme, Andaluz Health Service
1. Study Identification
Unique Protocol Identification Number
NCT06001034
Brief Title
Program of Supervised Occlusive Aerobic Training in People With Fibromyalgia.
Official Title
A 9-week Program of Supervised Occlusive Aerobic Training in People With Fibromyalgia in a Hospital Setting, and Its Impact on Blood/Plasma Variables, Quality of Life and Functional Autonomy.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
February 5, 2023 (Actual)
Study Completion Date
May 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
José Carlos Rodríguez Bautista
Collaborators
Universidad Pablo de Olavide, Hospital Universitario de Valme, Andaluz Health Service
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Occlusive training in people with fibromyalgia
Detailed Description
Intervention study in people with fibromyalgia with the implementation of a lower body occlusive tool in aerobic exercise. The study aims to descriptively test the impact on quality of life and functional autonomy of occlusive training in a controlled and individualized way in two groups: group 1 aerobic exercise with use of occlusive tool and group 2, aerobic exercise without occlusive tool in a period of 9 weeks twice a week.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
occlusive training
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1: Aerobic exercise plus occlusive tool. Group 2: Aerobic exercise without occlusive tool.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Aerobic exercise plus occlusive tool.
Arm Type
Experimental
Arm Description
Performing low-impact aerobic exercise with an occlusive tool 2 days per week.
Arm Title
Group 2: Aerobic exercise without occlusive tool.
Arm Type
No Intervention
Arm Description
Performing low-impact aerobic exercise without an occlusive tool 2 days per week.
Intervention Type
Device
Intervention Name(s)
Occlusion training
Other Intervention Name(s)
Occlusive cuffing during aerobic exercise in participants with fibromyalgia
Intervention Description
Impact of supervised occlusive training for 2 days per week for 10 weeks on quality of life and functional autonomy in participants with fibromyalgia.
Primary Outcome Measure Information:
Title
Change in Coenzyme Q10 after a 9-week intervention period.
Description
Coenzyme Q10
Time Frame
Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Title
Change in total antioxidants after a 9-week intervention period.
Description
TAS
Time Frame
Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Title
Change in disease impact questionnaire WPI after a 9-week intervention period.
Description
WPI; score between (0-19). The higher the score, the greater the impact of the disease.
Time Frame
Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Title
Change in disease impact questionnaire SSscore after a 9-week intervention period.
Description
SS score; score between (0-3) in the first half. Score between (0-40); between 1-10 (1 point), between 11-24 (2 points), more than 25 (3 points) in the second half. The higher the score, the greater the impact of the disease.
Time Frame
Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Title
Change in disease impact questionnaire FIQ after a 9-week intervention period.
Description
FIQ; score between (0-100). The higher the score, the greater the impact of the disease
Time Frame
Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Title
Change in disease impact questionnaire MFI-20 after a 9-week intervention period.
Description
MFI-20; (0-60) no fatigue. (60-70), fatigue, lighter or more severe, depending on the depending on the rating closer to 60 or 70 points. (more than 70 points), severe fatigue.
Time Frame
Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Title
Change in high density lipoproteins after a 9-week intervention period.
Description
HDL
Time Frame
Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Title
Change in low density lipoproteins after a 9-week intervention period.
Description
LDL
Time Frame
Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Title
Change in total cholesterol lipoproteins after a 9-week intervention period.
Description
CHOL
Time Frame
Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Title
Change in triglycerides after a 9-week intervention period.
Description
TG
Time Frame
Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Title
Changes in urea after a 9-week intervention period.
Description
Urea
Time Frame
Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Title
Changes in creatinine after a 9-week intervention period.
Description
Creatinine
Time Frame
Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Title
Change in gamma-glutamyl transferase after a 9-week intervention period.
Description
GGT
Time Frame
Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Title
Change in glutamic-pyruvic transaminase after a 9-week intervention period.
Description
GPT
Time Frame
Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Title
Change in glutamic oxaloacetic acid transaminase after a 9-week intervention period.
Description
GOT
Time Frame
Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Title
Change in alkaline phosphatase after a 9-week intervention period.
Description
ALP
Time Frame
Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Title
Change in funcional test after a 9-week intervention period.
Description
6-minute walking test
Time Frame
Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period)
Title
Change in funcional test after a 9-week intervention period.
Description
incremental shuttle walking test
Time Frame
Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period)
Title
Change in funcional test after a 9-week intervention period.
Description
30 second chair and stand test
Time Frame
Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Title
Change in funcional test after a 9-week intervention period.
Description
Time and go test
Time Frame
Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period)
Title
Change in malondialdehyde after a 9-week intervention period.
Description
MDA (malondialdehyde)
Time Frame
Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
Title
Change in distance traveled after a 9-week intervention period.
Description
Pedometer registration. Immediately after each session from week 1 to 9 of the intervention period. With a total of 18 recordings over the 9 weeks of the intervention period.
Time Frame
From week 1 to week 9 of the intervention period.
Title
Change in visual pain scale VAS over a 9-week intervention period.
Description
Visual pain scale (1-10). 1 being lighter and 10 being more severe. Visual pain scale recording. Before and immediately after each session from week 1 to week 9 of the intervention period. With a total of 36 recordings during the 9 weeks of the intervention period.
Time Frame
From week 1 to week 9 of the intervention period.
Title
Change in perceived exertion scale BORG over a 9-week intervention period.
Description
Perceived exertion scale. (1-10). 1 being lighter and 10 being more severe. Perceived exertion scale recording. Before and immediately after each session from week 1 to week 9 of the intervention period. With a total of 36 recordings during the 9 weeks of the intervention period.
Time Frame
From week 1 to week 9 of the intervention period.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A patient meets diagnostic criteria for fibromyalgia if the following three conditions are present: (American Rheumatology Association). Wolfe et al., (2010).
o 1) Widespread Pain Index (WPI) ≥ 7 and Symptom Severity Score (SS Score) ≥ 5 or WPI 3-6 and SS ≥ 9.
Symptoms have been present, at a similar level, during the last three months.
The patient has no other pathology that could explain the pain.
Recent negative COVID-19 test.
Exclusion Criteria:
Other associated pathologies that may hinder the development of the research.
Mobility limitations.
Injuries that add to those of the disease itself and hinder mobility.
No medical evaluation of the diagnosis of the disease.
Negative results in the inclusion tests.
Cardiac pathologies.
Blood pressure higher than 130-90 mmHg.
No COVID-19 test.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Carlos Rodríguez Bautista, PhD currently
Organizational Affiliation
Universidad Pablo de Olavide
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Pablo de Olavide
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Numeric code to each participant, concealing their personal data at all times.
IPD Sharing Time Frame
The protocol before the start and the numerical codes at the end of the intervention period.
IPD Sharing Access Criteria
Shared use only from principal investigator with collaborating investigators of the study.
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Links:
URL
https://upotv.upo.es/video/58da21db238583e0478b48f3
Description
30-second chair stand
URL
https://www.youtube.com/watch?v=8eRQexJzzUE
Description
Timed Up and Go test
URL
https://upotv.upo.es/video/5936500f238583f9658b464a
Description
6-Minute Walk test
URL
https://upotv.upo.es/video/5a72df02238583bd408b456a
Description
Incremental Shuttle Walk Test
Learn more about this trial
Program of Supervised Occlusive Aerobic Training in People With Fibromyalgia.
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