Nutrition and Movement to Improve Quality of Life With Knee Osteoarthritis

Osteo Arthritis Knee Clinical Trial

— NUMOQUA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05955300
• Other study ID #: NUMOQUA
• Status: Recruiting
• Phase: N/A
• Start date: January 6, 2024
• Est. completion date: March 2, 2025

Study information

• Verified date: December 2023
• Source: St. Pölten University of Applied Sciences
• Contact: Barbara Wondrasch, PhD
• Phone: +436504108196
• Email: barbara.wondrasch[@]fhstp.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2, 2025
• Est. primary completion date: April 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Mild to moderate knee osteoarthritis

Exclusion Criteria:

• Musculosceletal disorders which obviates a participation in the training program

• kognitive deficits

• internal, neurological and mental diseases

• drug and/or alcohol abuse

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Training program
The GLAD training program consists of neuromuscular exercises for the core, the knee and the hip muscles and patient education. The New Nordic Diet is a plant-based nutrition thats aims to reduce systematic low-grad inflammation.
• Nutrition therapy
Nutrition therapy based on the New Nordic Diet

Locations

Country	Name	City	State
Austria	St. Poelten University of Applied Sciences	St. Poelten
Austria	Sankt Pölten University of Applied Sciences	St. Pölten	Lower Austria

Sponsors (3)

Lead Sponsor	Collaborator
St. Pölten University of Applied Sciences	Danube University Krems, University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Injury and Osteoarthritis Outcome Score (Quality of Life)	Patient reported outcome measurement, Max: 100, Min: 0, Max is the best that can be achieved	9 Month