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The Effect of Telerehabilitation on Symptoms in Fibromyalgia Patients

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
High Intensity Interval Training
Moderate Exercise Training
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, high intensity interval training, telerehabilitation, tryptophan

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

High Intensity Interval Training

Moderate Exercise Training

Control

Arm Description

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.

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.

No aerobic exercise program will be applied to this group.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Pressure Pain Threshold Assessment
Pressure pain threshold assessment will be done with an algometer.
Evaluation of Grip Strength
Grip strength will be evaluated with a dynamometer (Hydraulic hand dynamometer).
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.
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.
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.
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.

Full Information

First Posted
August 10, 2022
Last Updated
March 25, 2023
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05502003
Brief Title
The Effect of Telerehabilitation on Symptoms in Fibromyalgia Patients
Official Title
Effect Of High Intensity Interval Upper Extremity Training On Biochemistry Parameters And Disease Symptoms In Patients With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 25, 2022 (Actual)
Primary Completion Date
January 25, 2023 (Actual)
Study Completion Date
January 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia, high intensity interval training, telerehabilitation, tryptophan

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Interval Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Moderate Exercise Training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No aerobic exercise program will be applied to this group.
Intervention Type
Other
Intervention Name(s)
High Intensity Interval Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Moderate Exercise Training
Intervention Description
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 Outcome Measure Information:
Title
Assessment of serum free tryptophan
Description
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.
Time Frame
6 weeks
Title
Assessment of 5-Hydroxyindolacetic Acid
Description
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.
Time Frame
6 weeks
Title
Assessment of Superoxide dismutase
Description
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.
Time Frame
6 weeks
Title
Assessment of Glutathione Peroxidase
Description
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.
Time Frame
6 weeks
Title
Assessment of Malondialdehyde
Description
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.
Time Frame
6 weeks
Title
Assessment of Myeloperoxidase
Description
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.
Time Frame
6 weeks
Title
Assessment of 25-hydroxy vitamin D
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Pressure Pain Threshold Assessment
Description
Pressure pain threshold assessment will be done with an algometer.
Time Frame
6 weeks
Title
Evaluation of Grip Strength
Description
Grip strength will be evaluated with a dynamometer (Hydraulic hand dynamometer).
Time Frame
6 weeks
Title
Evaluation of Fatigue
Description
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.
Time Frame
6 weeks
Title
Evaluation of Depression and Anxiety
Description
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.
Time Frame
6 weeks
Title
Evaluation of Quality of Sleep
Description
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.
Time Frame
6 weeks
Title
Evaluation of Functional Status Assessment
Description
Functional Status Assessment will be evaluated with The Revised Fibromyalgia Impact Questionnaire. A high score indicates that the disease affects the person more.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Health Sciences Bakırköy Dr. Sadi Konuk Training and Research Hospital
City
Istanbul
State/Province
Bakırköy
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
15206740
Citation
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.
Results Reference
background
PubMed Identifier
33918736
Citation
Siracusa 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.
Results Reference
background

Learn more about this trial

The Effect of Telerehabilitation on Symptoms in Fibromyalgia Patients

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