NCT04500444

Brief Summary

In our study, we aimed to evaluate and compare the effects of low-intensity aerobic exercise training with blood flow restriction and without blood flow restriction, on pain, functional status, quality of life and catecholamine metabolite levels in 24-hour urine in adults with Fibromyalgia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2020

Completed
Last Updated

August 5, 2020

Status Verified

August 1, 2020

Enrollment Period

10 months

First QC Date

August 3, 2020

Last Update Submit

August 4, 2020

Conditions

Fibromyalgia

Keywords

blood flow restriction trainingfibromyalgiaaerobic training

Outcome Measures

Primary Outcomes (1)

  • Change in Fibromyalgia Impact Questionnaire (FIQ) score

    The Fibromyalgia Impact Questionnaire (FIQ) was developed by clinicians at the Oregon Health Sciences University in the late 1980s to capture and evaluate the total spectrum of fibromyalgia-related problems and response to treatment. It was first used in 1991 and is still an indicator of therapeutic effectiveness today. it is used frequently. It consists of 10 questions to measure physical, emotional, cognitive and motivational symptoms such as physical disability, pain, fatigue, joint stiffness, depression and anxiety in fibromyalgia. Each question has been scored within itself. The total score will be between 0-100. 100 points indicate the highest exposure to the disease.

    Baseline, Immediately after the intervention , 3 months after the intervention period

Secondary Outcomes (4)

  • Change in Central Sensitization Inventory Score

    Baseline, Immediately after the intervention , 3 months after the intervention period

  • Change in Visual Analog Scale for Pain

    Baseline, Immediately after the intervention , 3 months after the intervention period

  • Change in Beck Depression Inventory Score

    Baseline, Immediately after the intervention , 3 months after the intervention period

  • Change in Chronic Pain Acceptance Questionnaire - 8 Score

    Baseline, Immediately after the intervention , 3 months after the intervention period

Study Arms (2)

Blood-Flow Restriction Group

EXPERIMENTAL

An aerobic exercise program with blood flow restriction will be applied 4 times a week for a total of 6 weeks. The aerobic exercise training consists of a warm up period for 5 minutes, walking on treadmill at 4 km per hour speed for 20 minutes and cooling down for another 5 minutes. The blood flow restriction protocol will be applied to both lower extremities at the crotch level with 10 cm wide elastic bandages before warming up. Before the first application, patients will be evaluated by a specialist physician using ultrasonography and it will be ensured that the arterial blood flow is not restricted as the blood flow restriction restricts only venous blood flow. The pressure threshold at this point is the level to be used in subsequent training sessions and the same person (physician) will be bandaging in the same way during all subsequent training sessions.

Other: exercise training

Control Group

SHAM COMPARATOR

An aerobic exercise program with blood flow restriction will be applied 4 times a week for a total of 6 weeks. The aerobic exercise training consists of a warm up period for 5 minutes, walking on treadmill at 4 km per hour speed for 20 minutes and cooling down for another 5 minutes. The sham blood flow restriction protocol will be applied which consists of loose bandaging to both lower extremities at the crotch level with 10 cm wide elastic bandages before warming up. The same person (physician) will be bandaging in the same way during all subsequent training sessions. The pressure feeling of the patient must correspond to level 0 -not tight at all- before starting the exercise training.

Other: exercise training

Interventions

exercise trainingOTHER

An aerobic exercise program with blood flow restriction will be applied 4 times a week for a total of 6 weeks. The aerobic exercise training consists of a warm up period for 5 minutes, walking on treadmill at 4 km per hour speed for 20 minutes and cooling down for another 5 minutes.

Also known as: low intensity aerobic training
Blood-Flow Restriction GroupControl Group

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being between 18 and 55 years old
  • Symptoms lasting longer than 3 months
  • According to the 2016 ACR criteria, the Common Pain Scale Score is ≥7 and the Symptom Severity Score is ≥5 or according to the 2016 ACR criteria, the Symptom Severity Score is ≥9 and the Common Pain Scale Score is between 4-6.
  • Fibromyalgia Impact Questionnaire (FIQ) score between 35 and 65 (out of 100)
  • To be able to come to the hospital for treatment 4 days a week for 6 weeks.
  • No change in the medical treatment received due to fibromyalgia syndrome during the study

You may not qualify if:

  • Presence of known central nervous system or peripheral nervous system disease, progressive neurological deficit
  • Peripheral venous insufficiency and coagulopathies
  • Serious cardiovascular pathologies
  • Sensory loss, loss of position sensation, unhealed fracture or open surgical wound
  • Uncontrolled hypertension, diabetes
  • Cognitive disorder causing simple commands difficulty
  • Pregnancy
  • Having entered the menopause

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Related Publications (7)

  • Evcik D, Ketenci A, Sindel D. The Turkish Society of Physical Medicine and Rehabilitation (TSPMR) guideline recommendations for the management of fibromyalgia syndrome. Turk J Phys Med Rehabil. 2019 May 28;65(2):111-123. doi: 10.5606/tftrd.2019.4815. eCollection 2019 Jun.

    PMID: 31453551BACKGROUND

  • Hauser W, Ablin J, Fitzcharles MA, Littlejohn G, Luciano JV, Usui C, Walitt B. Fibromyalgia. Nat Rev Dis Primers. 2015 Aug 13;1:15022. doi: 10.1038/nrdp.2015.22.

    PMID: 27189527BACKGROUND

  • Singh L, Kaur A, Bhatti MS, Bhatti R. Possible Molecular Mediators Involved and Mechanistic Insight into Fibromyalgia and Associated Co-morbidities. Neurochem Res. 2019 Jul;44(7):1517-1532. doi: 10.1007/s11064-019-02805-5. Epub 2019 Apr 19.

    PMID: 31004261BACKGROUND

  • Michiels V, Cluydts R. Neuropsychological functioning in chronic fatigue syndrome: a review. Acta Psychiatr Scand. 2001 Feb;103(2):84-93. doi: 10.1034/j.1600-0447.2001.00017.x.

    PMID: 11167310BACKGROUND

  • Bidonde J, Busch AJ, Bath B, Milosavljevic S. Exercise for adults with fibromyalgia: an umbrella systematic review with synthesis of best evidence. Curr Rheumatol Rev. 2014;10(1):45-79. doi: 10.2174/1573403x10666140914155304.

    PMID: 25229499BACKGROUND

  • Genc A, Tur BS, Aytur YK, Oztuna D, Erdogan MF. Does aerobic exercise affect the hypothalamic-pituitary-adrenal hormonal response in patients with fibromyalgia syndrome? J Phys Ther Sci. 2015 Jul;27(7):2225-31. doi: 10.1589/jpts.27.2225. Epub 2015 Jul 22.

    PMID: 26311959BACKGROUND

  • Patterson SD, Hughes L, Head P, Warmington S, Brandner C. Blood flow restriction training: a novel approach to augment clinical rehabilitation: how to do it. Br J Sports Med. 2017 Dec;51(23):1648-1649. doi: 10.1136/bjsports-2017-097738. Epub 2017 Jun 22. No abstract available.

    PMID: 28642225BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ayşegül Ketenci

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mert Zure, MD

CONTACT

+905356193965mertzure@gmail.com

Ayşegül Ketenci, Professor

CONTACT

draysegulketenci@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 3, 2020

First Posted

August 5, 2020

Study Start

November 13, 2019

Primary Completion

September 18, 2020

Study Completion

December 18, 2020

Last Updated

August 5, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)