Ignite Creation Date:
2024-05-06 @ 6:06 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05546294
Status:
COMPLETED
Last Update Posted:
2023-02-28
First Post:
2022-09-15
Brief Title:
The Effects of Exercise on Serum BDNF and Irisin Levels in Patients With Rheumatoid Arthritis
Sponsor:
Afyonkarahisar Health Sciences University
Organization:
Afyonkarahisar Health Sciences University
Study Overview
Official Title:
The Effects of Aerobic Exercise on Sleep Quality Fatigue Quality of Life Depression Serum BDNF and Irisin Levels in Patients With Rheumatoid Arthritis A Prospective Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Rheumatoid arthritis RA is a chronic progressive autoimmune disease characterized primarily by inflammation of synovial joints and tendon sheaths of synovial nature
Sleep disturbance in RA patients has a negative impact on their quality of life in addition to their mental and physical health Exercise has been identified as an important non-pharmacological factor in improving sleep quality and mood in patients with rheumatoid arthritis
Irisin is a myokine and adipokine that has anti-inflammatory effects and can help regulate energy expenditure It is secreted from skeletal muscles after exercise as well as from other tissues such as the liver nerves heart kidneys and skin It has been observed that serum irisin levels are decreased in RA patients with poor sleep quality compared to RA patients with good sleep quality
BDNF one of the biochemical parameters evaluating sleep is a signal protein encoded by the BDNF gene located on chromosome 11 It belongs to the neurotrophin family which regulates the survival development and function of neurons Neuronal activity is a powerful stimulant that elicits BDNF production Thus activation of brain areas associated with motor control during exercise contributes to increased BDNF production in the brain and additionally in plasma During acute exercise irisin stimulates BDNF expression in the hippocampus of the brain In addition to the circadian variation of plasma BDNF the blood concentration of BDNF has been shown to increase acutely in response to aerobic exercise that does not include resistance exercise Moreover it has been reported that people with higher basal serum BDNF concentrations have lower REM sleep and therefore less sleep disturbances
This investigation was designed as prospective randomized controlled study Participants were randomized into 3 groups RA patients receiving aerobic and home exercise RA patients receiving only home exercise and healthy control group
As evaluation parameters DAS28 Score SF Short form -36 Quality of Life Scale Pittsburgh Sleep Quality Index PSQI Fatigue Severity Scale FSS Beck Depression Inventory BDI 6 Minute Walk Test and Borg Scale will be evaluated with It was planned that the evaluations were made and recorded by a blinded physician to the all patients with rheumatoid arthritis at the beginning of the treatment and at the end of the treatmentIn the healthy control group the evaluation parameters will be examined only once at the beginning of the study
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 It will be checked whether there is a difference between the basal serum BDNF and irisin levels of rheumatoid arthritis patients with the blood sample taken only once in the early morning from the healthy control group
Sleep disturbance in RA patients has a negative impact on their quality of life in addition to their mental and physical health Exercise has been identified as an important non-pharmacological factor in improving sleep quality and mood in patients with rheumatoid arthritis
Irisin is a myokine and adipokine that has anti-inflammatory effects and can help regulate energy expenditure It is secreted from skeletal muscles after exercise as well as from other tissues such as the liver nerves heart kidneys and skin It has been observed that serum irisin levels are decreased in RA patients with poor sleep quality compared to RA patients with good sleep quality
BDNF one of the biochemical parameters evaluating sleep is a signal protein encoded by the BDNF gene located on chromosome 11 It belongs to the neurotrophin family which regulates the survival development and function of neurons Neuronal activity is a powerful stimulant that elicits BDNF production Thus activation of brain areas associated with motor control during exercise contributes to increased BDNF production in the brain and additionally in plasma During acute exercise irisin stimulates BDNF expression in the hippocampus of the brain In addition to the circadian variation of plasma BDNF the blood concentration of BDNF has been shown to increase acutely in response to aerobic exercise that does not include resistance exercise Moreover it has been reported that people with higher basal serum BDNF concentrations have lower REM sleep and therefore less sleep disturbances
This investigation was designed as prospective randomized controlled study Participants were randomized into 3 groups RA patients receiving aerobic and home exercise RA patients receiving only home exercise and healthy control group
As evaluation parameters DAS28 Score SF Short form -36 Quality of Life Scale Pittsburgh Sleep Quality Index PSQI Fatigue Severity Scale FSS Beck Depression Inventory BDI 6 Minute Walk Test and Borg Scale will be evaluated with It was planned that the evaluations were made and recorded by a blinded physician to the all patients with rheumatoid arthritis at the beginning of the treatment and at the end of the treatmentIn the healthy control group the evaluation parameters will be examined only once at the beginning of the study
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 It will be checked whether there is a difference between the basal serum BDNF and irisin levels of rheumatoid arthritis patients with the blood sample taken only once in the early morning from the healthy control group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None