The Effect of Telerehabilitation on Symptoms in Fibromyalgia Patients
Effect Of High Intensity Interval Upper Extremity Training On Biochemistry Parameters And Disease Symptoms In Patients With Fibromyalgia
1 other identifier
interventional
33
1 country
1
Brief Summary
The aim of this study is to evaluate the effect of telerehabilitation-based high-intensity interval upper extremity exercise training on biochemistry parameters and disease symptoms in fibromyalgia patients. It has been reported that substances such as serotonin and tryptophan are found at abnormal levels in the serotonergic system in patients with fibromyalgia, and symptoms such as depression, pain, and fatigue related to the disease may be associated with this condition. In the literature, there are studies conducted in other disease groups showing that aerobic exercise regulates tryptophan and serotonin levels and can produce positive results regarding these symptoms. This study was planned to evaluate the effect of high-intensity interval exercise training, which is an aerobic exercise form, whose benefits are frequently mentioned in recent publications, on both blood parameters and symptoms in fibromyalgia patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2022
CompletedFirst Posted
Study publicly available on registry
August 16, 2022
CompletedStudy Start
First participant enrolled
August 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2023
CompletedMarch 28, 2023
March 1, 2023
5 months
August 10, 2022
March 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Assessment of serum free tryptophan
Blood will be drawn from the participants in the morning. Centrifugation will be performed and the blood taken will be frozen.The analysis will be completed by following the manufacturer's instructions of the appropriate kits.
6 weeks
Assessment of 5-Hydroxyindolacetic Acid
Blood will be drawn from the participants in the morning. Centrifugation will be performed and the blood taken will be frozen.The analysis will be completed by following the manufacturer's instructions of the appropriate kits.
6 weeks
Assessment of Superoxide dismutase
Superoxide dismutase is the most important enzymatic antioxidants that prevent the initiation of lipid peroxidation. Blood will be drawn from the participants in the morning. Centrifugation will be performed and the blood taken will be frozen. The analysis will be completed by following the manufacturer's instructions of the appropriate kits.
6 weeks
Assessment of Glutathione Peroxidase
Glutathione Peroxidase is the most important enzymatic antioxidants that prevent the initiation of lipid peroxidation. Blood will be drawn from the participants in the morning. Centrifugation will be performed and the blood taken will be frozen. The analysis will be completed by following the manufacturer's instructions of the appropriate kits.
6 weeks
Assessment of Malondialdehyde
Blood will be drawn from the participants in the morning. Centrifugation will be performed and the blood taken will be frozen. The analysis will be completed by following the manufacturer's instructions of the appropriate kits.
6 weeks
Assessment of Myeloperoxidase
Blood will be drawn from the participants in the morning. Centrifugation will be performed and the blood taken will be frozen. The analysis will be completed by following the manufacturer's instructions of the appropriate kits.
6 weeks
Assessment of 25-hydroxy vitamin D
Blood will be drawn from the participants in the morning. Centrifugation will be performed and the blood taken will be frozen. The analysis will be completed by following the manufacturer's instructions of the appropriate kits.
6 weeks
Secondary Outcomes (6)
Pressure Pain Threshold Assessment
6 weeks
Evaluation of Grip Strength
6 weeks
Evaluation of Fatigue
6 weeks
Evaluation of Depression and Anxiety
6 weeks
Evaluation of Quality of Sleep
6 weeks
- +1 more secondary outcomes
Study Arms (3)
High Intensity Interval Training
EXPERIMENTALWith the arm ergometer given to the participants, a telerehabilitation-based upper extremity aerobic exercise program will be applied. Maximum Heart Rate (MHR) will be determined by the formula '220-age', and exercise intensity will be calculated, and exercise will begin with a 5 minute warm-up. Cycle will be created with 4 min MHR (80-95%) high intensity and 3 min MHR (70%) active recovery and exercise will be terminated with 5 min cool down. A total of 35 minutes of exercise program will be given.
Moderate Exercise Training
ACTIVE COMPARATORAn upper extremity exercise program with telerehabilitation (Zoom/videoconference) will be applied to the moderate-intensity exercise group. Maximum heart rate (MHR) will be determined by the formula 220-Age. A total of 55 minutes of moderate exercise training will be given at 65-70% of MHR, with five minutes of warm-up and cool-down.
Control
NO INTERVENTIONNo aerobic exercise program will be applied to this group.
Interventions
Telerehabilitation-based high-intensity exercise training will be applied to the participants for 6 weeks, 3 times a week for 35 minutes, under the control of a physiotherapist.
The participants will be given telerehabilitation-based moderate exercise training under the control of a physiotherapist for 55 minutes, 3 times a week for 6 weeks.
Eligibility Criteria
You may qualify if:
- Participants diagnosed with fibromyalgia according to the American College of Rheumatology 2016 criteria.
- Participants between the ages of 18-65
- Participants who do not use a drug that will affect the treatment results
- Participants who volunteer
You may not qualify if:
- Infection
- Fever
- Any known advanced-stage pathology associated with the locomotor system that contraindicates physical activity.
- Cardiopulmonary problem
- Presence of autoimmune disease
- Pregnancy
- Malignancy
- Severe psychiatric problem
- Neurological disorder
- Epilepsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Health Sciences Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Bakırköy, Turkey (Türkiye)
Related Publications (2)
Schwarz MJ, Offenbaecher M, Neumeister A, Ackenheil M. Experimental evaluation of an altered tryptophan metabolism in fibromyalgia. Adv Exp Med Biol. 2003;527:265-75. doi: 10.1007/978-1-4615-0135-0_30.
PMID: 15206740BACKGROUNDSiracusa R, Paola RD, Cuzzocrea S, Impellizzeri D. Fibromyalgia: Pathogenesis, Mechanisms, Diagnosis and Treatment Options Update. Int J Mol Sci. 2021 Apr 9;22(8):3891. doi: 10.3390/ijms22083891.
PMID: 33918736BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physiotherapist
Study Record Dates
First Submitted
August 10, 2022
First Posted
August 16, 2022
Study Start
August 25, 2022
Primary Completion
January 25, 2023
Study Completion
January 25, 2023
Last Updated
March 28, 2023
Record last verified: 2023-03