The Effects of Exercise on Serum BDNF and Irisin Levels in Patients With Rheumatoid Arthritis

NCT05546294 | Completed

• 1 other identifier: RAİRİSİNBDNF2021
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to investigate the effects of aerobic exercise on sleep quality, fatigue, quality of life, depression and serum BDNF and irisin levels, which are important biomarkers of sleep in patients with rheumatoid arthritis.

Conditions

Rheumatoid Arthritis; Sleep Quality; Aerobic Exercise

Keywords

Rheumatoid Arthritis; Sleep Quality; Serum BDNF; Serum Irisin; Quality of Life; Fatigue; Depression

Outcome Measures

Primary Outcomes (1)

• Change from baseline disease activity score (DAS28) at 4th week

  DAS 28 is a scale consisting of 4 parameters; tender and swollen joint counts from 28 joints (shoulders, elbows, wrists, MCFs,PIPs and knee joints), blood sedimentation (mm/hour) or CRP (mg/liter) value and patient global assessment (between 0 and 100; Best imaginable health condition-100, The worst possible health condition -0) A mathematical formula is used to calculate the overall score. DAS28 can range from 0 to 9.4.Generally, a DAS28 score of; * More than 5.1 indicates high disease activity * Between 3.2 and 5.1 indicates moderate disease activity * Between 2.6 and less than 3.2 indicates low disease activity * Lower than 2.6 indicates disease remission It is only applied to Rheumatoid Arthritis patients.

  Up to 4th week

Secondary Outcomes (6)

• Change from baseline quality of life (short form 36 (SF-36)) at 4th week

  Up to 4th week

• Change from baseline Fatigue Severity Scale (FSS) at 4th week

  Up to 4th week

• Change from baseline Beck's Depression Inventory (BDI) at 4th week

  Up to 4th week

• Change from baseline Pittsburgh Sleep Quality Index (PSQI) at 4th week

  Up to 4th week

• Change from baseline Six Minute Walk Test (6MWT) at 4th week

  Up to 4th week

Study Arms (3)

RA patients receiving aerobic and home exercise

EXPERIMENTAL

A total of 20 sessions of aerobic exercises using bicycle ergometer, five times a week and once a day for four weeks, were applied to the patients. Then the patients were showed a daily home exercise program to apply once a day at their home.

Device: Aerobic and home exercise

RA patients receiving only home exercise

ACTIVE COMPARATOR

The patients were showed only a daily home exercise program to apply once a day at their home.

Other: Home exercise

Healthy control group

OTHER

There is no intervention to this group.

Other: Healthy control group

Interventions

Aerobic and home exercise DEVICE

A total of 20 sessions of aerobic exercises using bicycle ergometer, five times a week and once a day for four weeks, were applied to the patients.Maximum heart rate was calculated for each subject (220 - age) and a heart rate monitor will be used to follow subjects' heart rate during aerobic exercise. Then the patients were showed a daily home exercise program to apply once a day at their home. As a daily home exercise program:ROM exercises and strengthening exercises for major muscle groups (such as abdominal muscles, erector spinae, hamstring, quadriceps, hip flexors, strengthening exercises for all extremities) were showed. At the beginning of the treatment and at the end of the treatment (4th week), serum BDNF and irisin levels will be tested using the ELISA kit, with blood samples taken from the RA patients in the early morning.

RA patients receiving aerobic and home exercise

Home exercise OTHER

The patients were showed only a daily home exercise program to apply once a day at their home. As a daily home exercise program:ROM exercises and strengthening exercises for major muscle groups (such as abdominal muscles, erector spinae, hamstring, quadriceps, hip flexors, strengthening exercises for all extremities) were showed. At the beginning of the treatment and at the end of the treatment (4th week), serum BDNF and irisin levels will be tested using the ELISA kit, with blood samples taken from the RA patients in the early morning.

RA patients receiving only home exercise

Healthy control group OTHER

Serum BDNF and irisin levels will be tested using the ELISA kit, with blood samples taken only once from healthy control group in the early morning. It will be checked whether there is a difference between the basal serum BDNF and irisin levels of rheumatoid arthritis patients and healthy control group.

Healthy control group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female gender between the ages of 20 and 60 who were diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR diagnostic criteria,
• Patients with Disease Activity Score (DAS28) ≤3.2 (low disease activity or remission) (no change in anti-rheumatic drugs or steroid dose in the last 3 months),
• Patients who were being followed at Afyonkarahisar Health Sciences University Department of Physical Medicine and Rehabilitation,

You may not qualify if:

• Active malignancy and/or a history of malignancy within the past 5 years,
• Uncontrolled cardiopulmonary disease (such as severe hypertension, chronic obstructive pulmonary disease, stage 3 or 4 heart failure, significant left ventricular outflow obstruction, dissecting aneurysm, embolism or thrombophlebitis history),
• Patients who cannot tolerate cardiorespiratory exercise training due to unstable angina pectoris, dangerous cardiac arrhythmias and myocardial infarction in the last 3 months,
• Pregnancy or planning a pregnancy in the near future,
• History of major surgery (including joint surgery) within the last six months,
• Regular physical activity at least 3 days a week in the last 3 months,
• Orthopedic, neurological or mental disease that may affect exercise,

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, 03200, Turkey (Türkiye)

Location

Related Publications (3)

• Baillet A, Zeboulon N, Gossec L, Combescure C, Bodin LA, Juvin R, Dougados M, Gaudin P. Efficacy of cardiorespiratory aerobic exercise in rheumatoid arthritis: meta-analysis of randomized controlled trials. Arthritis Care Res (Hoboken). 2010 Jul;62(7):984-92. doi: 10.1002/acr.20146.

  PMID: 20589690 BACKGROUND

• Gamal RM, Mohamed ME, Hammam N, El Fetoh NA, Rashed AM, Furst DE. Preliminary study of the association of serum irisin levels with poor sleep quality in rheumatoid arthritis patients. Sleep Med. 2020 Mar;67:71-76. doi: 10.1016/j.sleep.2019.10.021. Epub 2019 Nov 30.

  PMID: 31918120 BACKGROUND

• Tan X, van Egmond LT, Cedernaes J, Benedict C. The role of exercise-induced peripheral factors in sleep regulation. Mol Metab. 2020 Dec;42:101096. doi: 10.1016/j.molmet.2020.101096. Epub 2020 Oct 9.

  PMID: 33045432 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid; Sleep Initiation and Maintenance Disorders; Fatigue; Depression

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Ümit DÜNDAR, MD

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

• Hatice Kudret MİROĞLU, MD

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Doctor

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 19, 2022
• Study Start: March 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: February 20, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)