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Набор скоро начнётся NCT07327073

The Effect of Exercise on Serum Irisin Levels and Clinical Parameters in Patients With Axial Spondyloarthritis.

Без фазы С лечением Ankylosing Spondylitis (AS) Irisin

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: High-Intensity Interval Training, Moderate-Intensity Continuous Exercise, control group.
Кому может быть актуально
Состояния в реестре: Ankylosing Spondylitis (AS), Irisin. Базовые параметры: 18 лет — 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

The Effect of High-intensity Intermittent Exercise and Moderate-intensity Continuous Exercise on Serum Irisin Levels, Disease Activity, Functional Status, and Quality of Life in Patients With Axial Spondyloarthritis: a Prospective, Randomized Study

Обзор

This study aimed to investigate the effects of high-intensity intermittent exercise and moderate-intensity continuous exercise on serum irisin levels, disease activity, functional status, and quality of life in patients with axial spondyloarthritis.

Подробное описание

Axial spondyloarthritis (axSpA) is a chronic inflammatory rheumatic disease affecting young individuals, with a prevalence of 0.3-1.4%. The main features of the disease include inflammatory back pain, reduced joint mobility, and functional disability. In addition, accumulating evidence over recent years has demonstrated that inflammatory rheumatic diseases are associated with an increased risk of cardiovascular disease. Exercise constitutes an important component of the management of inflammatory rheumatic diseases and is widely used to reduce pain and improve joint mobility.

Irisin is a myokine secreted by skeletal muscle through the cleavage of the membrane protein fibronectin type III domain-containing protein 5 (FNDC-5). Irisin is considered a mediator of exercise-induced metabolic benefits and has been shown to exert protective effects in several non-metabolic diseases. At the molecular level, irisin contributes to increased energy expenditure and metabolic regulation by promoting the browning of white adipose tissue. Previous studies have demonstrated that serum irisin levels increase following exercise.

Studies evaluating the role of irisin in ankylosing spondylitis have reported lower serum irisin levels in patients with more severe disease manifestations. However, no studies investigating the effects of exercise therapy on serum irisin levels in patients with axial spondyloarthritis have been identified in the literature. Previous research has focused on the relationship between disease severity and serum irisin levels, as well as the association between serum irisin levels and cardiovascular disease in patients with ankylosing spondylitis. Overall, low serum irisin levels are thought to be indicative of subclinical atherosclerosis, increased cardiovascular risk, and more severe disease. Evaluating the relationship between serum irisin levels and exercise in patients with axial spondyloarthritis may provide important contributions to disease management and follow-up. Therefore, the present study aimed to investigate the effects of high-intensity intermittent exercise and moderate-intensity continuous exercise on serum irisin levels, disease activity, functional status, and quality of life in patients with axial spondyloarthritis.

Вмешательства

  • Другое High-Intensity Interval Training
    Patients will be trained at 80% to 100% of their maximum heart rate. For the first 4 weeks, they will train at 80% of their maximum heart rate, then at 85%, 90%, 95%, and finally 100%. This protocol will consist of 4 active periods of 4 minutes each at 80% to 100% of maximum heart rate (percentage to be determined weekly) and 3 rest periods of 3 minutes each at 60-70% of maximum heart rate (4x4 minutes). Each session will include a 5-minute warm-up before HIIT and a 5-minute cool-down after HIIT
  • Другое Moderate-Intensity Continuous Exercise
    Patients will be trained for 30 minutes at 50% to 70% of their maximum heart rate and with an RPE of 11-13. Each session will include a 5-minute warm-up before MCIT and a 5-minute cool-down after MCIT, for a total exercise time of 40 minutes.
  • Другое control group
    They will be given information and education about their illnesses and will be advised to continue their current medical treatment and attend their follow-up appointments regularly.

Первичные конечные точки

  • serum irisin level [Срок оценки: Before treatment and after treatment (week 8)]
Вторичные конечные точки (5)
  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Срок оценки: Before treatment, after treatment (week 8)]
  • Ankylosing Spondylitis Activity Scoring-CRP (ASDAS-CRP) [Срок оценки: Before treatment, after treatment (week 8)]
  • Bath Ankylosing Spondylitis Functional Index (BASFI) [Срок оценки: Before treatment, after treatment (week 8)]
  • Bath Ankylosing Spondylitis Metrology Index (BASMI) [Срок оценки: Before treatment, after treatment (week 8)]
  • Ankylosing Spondylitis Quality of Life Scale (ASQoL) [Срок оценки: Before treatment, after treatment (week 8)]

Критерии участия

Критерии включения

  • Patients diagnosed with axillary spondyloarthropathy according to ASAS diagnostic criteria,
  • Having a high disease severity (ASDAS-CRP above 2.1),
  • Being sedentary (not engaging in physical activity at least 3 days a week in the last 3 months),
  • Having no change in ankylosing spondylitis medical treatment in the last 3 months,
  • Not having any orthopedic, neurological, cardiovascular, or mental disease that would affect exercise,
  • Not using any assistive devices for ambulation,
  • Having a BMI of 25 kg/m2 or less,
  • Male and female patients aged 18-50 years.

Критерии исключения

  • Those with uncontrolled cardiopulmonary disease (such as hypertension, chronic obstructive pulmonary disease, heart failure),
  • Having comorbidities that reduce exercise capacity,
  • Pregnancy,
  • Malignancy,
  • Those with a recent history of surgery,
  • Those who have engaged in regular exercise (aquatic exercise, land exercise, etc.) in the previous 3 months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Kırşehir Ahi Evran Üniversitesi — Kırşehir

Идентификаторы

NCT: NCT07327073 · AhiEvranU-FTR-NK-AS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗