Effect of Structured Exercise in Patients With Knee Osteoarthritis

Официальное название

Effect of Nordic Walking and Inspiratory Muscle Training to Promote Cardiopulmonary Function in Patients With Knee Osteoarthritis

Обзор

The aim of this randomized controlled trial is to evaluate the effect of Nordic walking and inspiratory muscle training (IMT) on cardiopulmonary function in patients with knee osteoarthritis (OA). Mild-to-moderate knee OA patients are randomly allocated into Experimental group (Nordic walking plus routine management) or Control group (Routine management). While End-stage knee OA patients are randomly allocated into Experimental group (IMT plus pre-operative rehabilitation exercise) or Control group (Pre-operative rehabilitation exercise). Participants are invited to undergo two assessments, including baseline assessment, post-intervention assessment. Researchers will compare two groups to see if the cardiopulmonary function can be improved after intervention.

Подробное описание

This study recruits patients with different stages and assigns them into different interventions and comparing the effect with those not receiving intervention. It will provide the evidence in terms of the exercise that can promote cardiopulmonary function and at the same time reduce pain and disability for patients with different stages of knee osteoarthritis.

Вмешательства

• Устройство Nordic walking or inspiratory muscle training
  Nordic walking is a form of low-impact aerobic exercise that incorporates the use of walking poles. And inspiratory muscle training is a type of exercise that provides resistance during the inhalation phase.

Первичные конечные точки

• The six-minute walk test [Срок оценки: Baseline, up to 8 weeks]
• 30-sec chair stand test [Срок оценки: Baseline, up to 8 weeks]
• Grip strength [Срок оценки: Baseline, up to 8 weeks]
• Timed up-and-go test [Срок оценки: Baseline, up to 8 weeks]
• Quadriceps strength [Срок оценки: Baseline, up to 8 weeks]

Вторичные конечные точки (12)

• Forced vital capacity [Срок оценки: Baseline, up to 8 weeks]
• Forced expiratory volume at first second [Срок оценки: Baseline, up to 8 weeks]
• Maximum voluntary ventilation [Срок оценки: Baseline, up to 8 weeks]
• Inspiratory muscle strength [Срок оценки: Baseline, up to 8 weeks]
• Inspiratory muscle endurance [Срок оценки: Baseline, up to 8 weeks]
• Quadriceps muscle oxygenation [Срок оценки: Baseline, up to 8 weeks]
• Multidimensional Fatigue Inventory [Срок оценки: Baseline, up to 8 weeks]
• Medical Research Council scale [Срок оценки: Baseline, up to 8 weeks]
• Physical Activity Scales for the Elderly [Срок оценки: Baseline, up to 8 weeks]
• Actigraph [Срок оценки: Baseline, up to 8 weeks]
• Pittsburgh Sleep Quality Index [Срок оценки: Baseline, up to 8 weeks]
• Western Ontario and McMaster Universities Osteoarthritis Index [Срок оценки: Baseline, up to 8 weeks]

Критерии участия

Критерии включения

• pain on the most days in one or both knees in the past month;
• difficulty with at least one of daily living activities measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale;
• radiographic evidence of knee OA in the tibial-femoral compartment (Kellgren and Lawrence grade, K/L ≥1, K/L 1-3 regarded as mild-to-moderate knee OA, others waiting for knee arthroplasty regarded as end-stage knee OA);
• with normal or corrected visual and auditory function and walking unaided;
• primary knee OA for more than 6 months, be stable on medication for at least 3 weeks.

Критерии исключения

• knee surgery priorly;
• have steroid injection in previous three weeks;
• have inflammatory arthritis (e.g., rheumatoid); or unstable angina, or myocardial infarction, or cardiac surgery; or stroke; or treatment with steroids, hormones, or cancer chemotherapy; or pulmonary diseases (force vital capacity<80% of predicted and/or forced expiratory volume at first second<70% of predicted); or a history of exercise-induced asthma;
• unable to understand the procedure and potential risks of the study;
• medically unstable that indicate unsafe to participate in exercise test

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The Hong Kong Polytechnic University — Kowloon City

Идентификаторы

NCT: NCT06084949 · HSEARS20230703001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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