Feasibility of Resting Intervals During Exercise Programs for Individuals With Knee Osteoarthritis

Официальное название

Mechanical and Molecular Determinants of Cartilage Response to Exercise

Обзор

This pilot randomize trial tests the feasibility of administering two different exercise programs in people with knee osteoarthritis. One group receives the exercise program administered as usual, and the other group received the exercise program with resting intervals.

Подробное описание

Participants will be randomly assigned to 1 of 2 treatment groups. Both groups do the same exercise program 3 times a week for 12 weeks on nonconsecutive days. The only difference is that one group will perform the exercises with small resting periods between exercises as normally done in clinical practice. The other group will have two long rests of 45 minutes during the exercise training session. Before and after the exercise programs, participants will undergo a series of assessments including gait analysis, MRI imaging of knees, tests of muscle strength and physical performance. Questionnaires will be completed. Blood and synovial fluid will be collected as part of this study.

Вмешательства

• Поведенческое Exercise with Rest
  Participants in this arm exercise 3 times a week for 12 weeks. Exercise program consists of warm-up, strengthening exercises of the lower major extremity muscle groups, and aerobic training using a treadmill. These sessions include two 45 minute rest periods between exercises and take about two and a half hours.
• Поведенческое Exercise without Rest
  Participants in this arm exercise 3 times a week for 12 weeks. Exercise program consists of warm-up, strengthening exercises of the lower major extremity muscle groups, and aerobic training using a treadmill. These sessions include minimal resting periods between exercises and take about one hour.

Первичные конечные точки

• Feasibility of recruitment [Срок оценки: The time frame for this outcome is from the enrollment period up to randomization. This outcome measure is independent of treatment assignment.]

Вторичные конечные точки (1)

• Safety of interventions [Срок оценки: 3 months (window of 1 month)]

Критерии участия

Критерии включения

• Age between 45 and 79 yo.
• Clinical diagnosis of primary, early to moderate stage knee osteoarthritis.
• BMI range < 35 kg/m2.
• Sedentary lifestyle
• Knee joint is the most painful joint in the body.
• Ability to speak and understand English.
• Willingness to comply with all study procedures and be available for the duration of the study.

Критерии исключения

• Non-OA disease of the knee.
• Advanced knee osteoarthritis
• Knee injection in the past 3 months.
• Major knee trauma/surgery in the past 5 years or previous knee surgery with hardware limiting cartilage assessment..
• Participate in regular exercise or physical activity .
• Participation in an intervention study for knee OA.
• Currently using a cane, walker or crutches to walk.
• History of cardiovascular disease or hypertension not controlled by medication.
• Two or more unexplained falls in the past year.
• Inflammatory, autoimmune disorders, neurological, systemic, muscular, or connective tissue conditions that affect walking or ability to exercise.
• Contraindication to MRI.
• Medical condition or characteristic of the participant that could place the individual at increased risk or preclude s/he from complying with study procedures.
• Pregnant female.
• Acute or terminal illness.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT06857123 · STUDY23050179

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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