FibromyalgiaNCT05502003
The Effect of Telerehabilitation on Symptoms in Fibromyalgia Patients
A study testing High Intensity Interval Training and Moderate Exercise Training in people with Fibromyalgia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- High Intensity Interval Training and Moderate Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2022to 25 Jan 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Infection
- Fever
- Any known advanced-stage pathology associated with the locomotor system that contraindicates physical activity.
- Cardiopulmonary problem
- Presence of autoimmune disease
- Pregnancy
Show all 10Show fewer
- Malignancy
- Severe psychiatric problem
- Neurological disorder
- Epilepsy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Bakırköy
About this study
Official title: Effect Of High Intensity Interval Upper Extremity Training On Biochemistry Parameters And Disease Symptoms In Patients With Fibromyalgia
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.
Read the detailed description
Fibromyalgia is a chronic musculoskeletal disease of unknown etiology accompanied by symptoms such as pain, hyperalgesia, sleep disorders, fatigue and mood disorders. It has been suggested that a defect in the serotonergic system is involved in the pathophysiology of the disease. The serotonergic system has been associated with many symptoms such as anxiety, depression, sleep problems, fatigue and pain. In studies on fibromyalgia, it was reported that plasma tryptophan and serotonin levels decreased in this patient group and that serotonin levels were abnormal in the endogenous pain blocking pathways. Although conflicting results have been reported, it was stated that vitamin D levels were also low in this patient group. Aerobic exercise makes muscles use branched-chain amino acids, reducing the amount of amino acids that compete with tryptophan and increasing the chance of tryptophan to cross the blood-brain barrier. Therefore, it has the potential to increase serotonin in the brain. In particular, aerobic exercise appears to modulate hormone, neurotrophin and neurotransmitter levels, depending on factors such as genes, age and hormonal status. On the other hand, it is reported that some types of exercise increase the production of free radicals and cause oxidative stress. It has been suggested that oxidative stress may be associated with pain, which is one of the main symptoms in fibromyalgia patients by affecting nociceptors. Studies have shown that when aerobic exercises are applied regularly for a long time, lipid peroxidation level, which is an indicator of oxidative stress, decreases and antioxidant enzyme activity increases. Regularly applied aerobic exercise programs have been reported as a suitable form of exercise for this patient group. Recent studies have focused on high-intensity interval training. This type of exercise; It is performed as successive short and intermittent sessions of high-intensity activity with periods of low intensity or rest. High-intensity interval training are shorter than moderate aerobic workouts and produce the same or more positive effects than moderate exercise. It is also reported that high-intensity interval training application improves oxidative capacity, antioxidant defense and endothelial functions. Telerehabilitation practices refer to the use of telematics procedures using telephone, video and computer technologies instead of traditional face-to-face approaches. The therapist ensures that patient communication and follow-up are maintained by maintaining social distance. It has been stated in studies that telerehabilitation can be used to increase the quality of life, to provide socialization and to treat pain in patients with fibromyalgia. This study was designed to evaluate the effectiveness of high-intensity interval training upper extremity exercise training, which is a form of aerobic exercise, on these parameters, associated symptoms and oxidative stress markers in fibromyalgia patients with negative effects on serotonin, tryptophan, vitamin D and related parameters.
- Conditions
- Fibromyalgia
- Being tested
- High Intensity Interval Training, Moderate Exercise Training
- Keywords
- fibromyalgia, high intensity interval training, telerehabilitation, tryptophan
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval TrainingOther
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.
Moderate Exercise TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training | Experimental | With 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. Receives: Other: High Intensity Interval Training |
| Moderate Exercise Training | Active comparator | An 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. Receives: Other: Moderate Exercise Training |
| Control | No intervention | No aerobic exercise program will be applied to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (6)
Pressure Pain Threshold Assessment
Pressure pain threshold assessment will be done with an algometer.
Measured: 6 weeks
Evaluation of Grip Strength
Grip strength will be evaluated with a dynamometer (Hydraulic hand dynamometer).
Measured: 6 weeks
Evaluation of Fatigue
Fatigue will be evaluated with Fatigue Severity Scale. Each item of the scale, which consists of 9 items that patients can apply on their own, is scored between 1 and 7 (1 = strongly disagree, 7 = completely agree) and the total score is calculated by taking the average of 9 items. The lower the total score, the less fatigue.
Measured: 6 weeks
Evaluation of Depression and Anxiety
Depression and anxiety will be evaluated with Hospital Anxiety and Depression Scale. Each item of the 14-item scale is scored between 0 and 3. For anxiety and depression values, 0-7 points are considered normal, 8-10 points are borderline, and 11 points and above are considered abnormal.
Measured: 6 weeks
Evaluation of Quality of Sleep
Quality of Sleep will be evaluated with Pittsburgh Sleep Quality Index. The total score is between 0-21. A high total score indicates poor sleep quality.
Measured: 6 weeks
Evaluation of Functional Status Assessment
Functional Status Assessment will be evaluated with The Revised Fibromyalgia Impact Questionnaire. A high score indicates that the disease affects the person more.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start25 Aug 2022
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selin Akıl Ağdere, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502003
- Sponsor's protocol ID
- aerobic exercise
- Status last verified
- Mar 2023
- First submitted
- 10 Aug 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 15206740Siracusa 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.
PubMed 33918736
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of High Intensity Interval Upper Extremity Training On Biochemistry Parameters And Disease Symptoms In Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT05502003
- Acronym / sponsor ID
- aerobic exercise
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, high intensity interval training, telerehabilitation, tryptophan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 16 Aug 2022 (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.
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.
Detailed description
Fibromyalgia is a chronic musculoskeletal disease of unknown etiology accompanied by symptoms such as pain, hyperalgesia, sleep disorders, fatigue and mood disorders. It has been suggested that a defect in the serotonergic system is involved in the pathophysiology of the disease. The serotonergic system has been associated with many symptoms such as anxiety, depression, sleep problems, fatigue and pain. In studies on fibromyalgia, it was reported that plasma tryptophan and serotonin levels decreased in this patient group and that serotonin levels were abnormal in the endogenous pain blocking pathways. Although conflicting results have been reported, it was stated that vitamin D levels were also low in this patient group. Aerobic exercise makes muscles use branched-chain amino acids, reducing the amount of amino acids that compete with tryptophan and increasing the chance of tryptophan to cross the blood-brain barrier. Therefore, it has the potential to increase serotonin in the brain. In particular, aerobic exercise appears to modulate hormone, neurotrophin and neurotransmitter levels, depending on factors such as genes, age and hormonal status. On the other hand, it is reported that some types of exercise increase the production of free radicals and cause oxidative stress. It has been suggested that oxidative stress may be associated with pain, which is one of the main symptoms in fibromyalgia patients by affecting nociceptors. Studies have shown that when aerobic exercises are applied regularly for a long time, lipid peroxidation level, which is an indicator of oxidative stress, decreases and antioxidant enzyme activity increases. Regularly applied aerobic exercise programs have been reported as a suitable form of exercise for this patient group. Recent studies have focused on high-intensity interval training. This type of exercise; It is performed as successive short and intermittent sessions of high-intensity activity with periods of low intensity or rest. High-intensity interval training are shorter than moderate aerobic workouts and produce the same or more positive effects than moderate exercise. It is also reported that high-intensity interval training application improves oxidative capacity, antioxidant defense and endothelial functions. Telerehabilitation practices refer to the use of telematics procedures using telephone, video and computer technologies instead of traditional face-to-face approaches. The therapist ensures that patient communication and follow-up are maintained by maintaining social distance. It has been stated in studies that telerehabilitation can be used to increase the quality of life, to provide socialization and to treat pain in patients with fibromyalgia. This study was designed to evaluate the effectiveness of high-intensity interval training upper extremity exercise training, which is a form of aerobic exercise, on these parameters, associated symptoms and oxidative stress markers in fibromyalgia patients with negative effects on serotonin, tryptophan, vitamin D and related parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training | Experimental | Other: High Intensity Interval TrainingWith 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 comparator | Other: Moderate Exercise TrainingAn 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 intervention | –No aerobic exercise program will be applied to this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Infection
- Fever
- Any known advanced-stage pathology associated with the locomotor system that contraindicates physical activity.
- Cardiopulmonary problem
- Presence of autoimmune disease
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 |
|---|---|---|
| High Intensity Interval TrainingTelerehabilitation-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. | Other | High Intensity Interval Training |
| Moderate Exercise TrainingThe 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. | Other | Moderate Exercise Training |
Primary outcome
Assessment of serum free tryptophan
Time frame: 6 weeks
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.
Assessment of 5-Hydroxyindolacetic Acid
Time frame: 6 weeks
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.
Assessment of Superoxide dismutase
Time frame: 6 weeks
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.
Assessment of Glutathione Peroxidase
Time frame: 6 weeks
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.
Assessment of Malondialdehyde
Time frame: 6 weeks
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.
Assessment of Myeloperoxidase
Time frame: 6 weeks
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.
Assessment of 25-hydroxy vitamin D
Time frame: 6 weeks
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 secondary outcomes
Pressure Pain Threshold Assessment
Time frame: 6 weeks
Evaluation of Grip Strength
Time frame: 6 weeks
Evaluation of Fatigue
Time frame: 6 weeks
Evaluation of Depression and Anxiety
Time frame: 6 weeks
Evaluation of Quality of Sleep
Time frame: 6 weeks
Evaluation of Functional Status Assessment
Time frame: 6 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 28 Mar 2023.
- Background: PubMed 15206740Schwarz 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.
- Background: PubMed 33918736Siracusa 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training and Moderate Exercise Training in people with Fibromyalgia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 10 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 28 Mar 2023. 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 Turkey (Türkiye). 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?
Assessment of serum free tryptophan (time frame: 6 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05502003, which also lists 2 linked publications.
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 28 Mar 2023.