Skip to main content
OpenTrials
Completed

NCT Number: NCT05502003

The Effect of Telerehabilitation on Symptoms in Fibromyalgia Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Bakırköy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Bakırköy, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

High Intensity Interval Training

Other

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 Training

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Secondary outcomes

  1. Pressure Pain Threshold Assessment

    Time frame: 6 weeks

    Pressure pain threshold assessment will be done with an algometer.

  2. Evaluation of Grip Strength

    Time frame: 6 weeks

    Grip strength will be evaluated with a dynamometer (Hydraulic hand dynamometer).

  3. Evaluation of Fatigue

    Time frame: 6 weeks

    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.

  4. Evaluation of Depression and Anxiety

    Time frame: 6 weeks

    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.

  5. Evaluation of Quality of Sleep

    Time frame: 6 weeks

    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.

  6. Evaluation of Functional Status Assessment

    Time frame: 6 weeks

    Functional Status Assessment will be evaluated with The Revised Fibromyalgia Impact Questionnaire. A high score indicates that the disease affects the person more.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

Effect Of High Intensity Interval Upper Extremity Training On Biochemistry Parameters And Disease Symptoms In Patients With Fibromyalgia

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 16, 2022
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.