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临床试验/NCT05955300
NCT05955300招募中不适用

Evidence Based Training Program Combined With Nutrition Therapy for Patients With Knee Osteoarthritis

St. Pölten University of Applied Sciences4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
4
主要终点
Knee Injury and Osteoarthritis Outcome Score (Quality of Life)

研究概览

简要总结

This project aims to evaluate the effects of an evidence-based training program in combination with an antiinflammatory dietetic intervention on quality of life for patients with knee osteoarthritis

详细描述

Osteoarthritis (OA) is the most prevalent arthritic disease worldwide characterized by pain, effusion and stiffness leading to functional decline and reduced quality of life (QL). It has been long considered as a degenerative disease of cartilage resulting from bodily wear and tear that affect the entire joint structure. However, there is accumulating evidence that inflammation plays a key role in the OA pathogenesis. Triggered from tissue damage and by metabolic dysfunction, inflammatory processes within the joint may trigger the development of chronic low-grade inflammation.

Factors that contribute to chronic low-grade inflammation include a nutrient overload, a metabolic surplus, pro-inflammatory cytokines and adipokines. Knee OA is the most common form of OA with prevalence rising with age peaked at around 50 years of age affecting more than 250 million people worldwide. Exercise therapy (ET) is an effective component of early treatment and is therefore recommended as a first line treatment. Good Life with osteoArthritis in Denmark (GLA:D®) represents an evidence-based treatment plan for knee OA and optimizes the implementation of ET. However, ET mainly addresses physical and functional deficits in patients with knee OA, but not the inflammatory processes. Due to the association of chronic low-grad inflammation with dietary patterns, nutrition plays a significant role in inflammation-related diseases. A plant-based, anti-oxidative and anti-inflammatory therapeutic diet helps to improve symptoms leading to improved quality of life. When implementing a therapeutic diet, it should be attractive for patients and regional needs should be considered. This might increase adherence to therapeutic diet and will have an environmental impact - the New Nordic Diet (NND) seems to fulfil these requirements. To our knowledge no study has examined the influence of NND on symptoms and QL in OA. Further, there is a lack of knowledge concerning the impact of exercise therapy AND nutrition therapy on symptoms and QL in patients with knee OA.

Aims

  1. To evaluate the effect of a nutrition therapy combined with exercise therapy on QL in patients knee OA
  2. To investigate the impact of a nutrition therapy combined with exercise therapy on symptoms, nutrition and inflammation status and joint function in patients with knee OA

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mild to moderate knee osteoarthritis

排除标准

  • Musculosceletal disorders which obviates a participation in the training program
  • kognitive deficits
  • internal, neurological and mental diseases
  • drug and/or alcohol abuse

结局指标

主要结局

Knee Injury and Osteoarthritis Outcome Score (Quality of Life)

时间窗: 9 Month

Patient reported outcome measurement, Max: 100, Min: 0, Max is the best that can be achieved

次要结局

未报告次要终点

研究者

发起方
St. Pölten University of Applied Sciences
申办方类型
Other
责任方
Sponsor

研究点 (4)

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