Nutrition and Movement to Improve Quality of Life With Knee Osteoarthritis (NUMOQUA)

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

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

Study Overview

• Status: Recruiting
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Other: Training program; Other: Nutrition therapy

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Barbara Wondrasch, PhD; Phone Number: +436504108196; Email: barbara.wondrasch@fhstp.ac.at
• Study Contact Backup: Name: Sabine Chmelar, MSc; Email: sabine.chmelar@fhstp.ac.at

Study Locations

• Austria
  • St. Poelten, Austria, 3100
    • Recruiting
    • St. Poelten University of Applied Sciences
    • Contact: Barbara Wondrasch, PhD; Phone Number: +436504108196; Email: barbara.wondrasch@fhstp.ac.at
    • Contact: Sabine Chmelar, MSc; Email: sabine.chmelar@fhstp.ac.at
  • Lower Austria
    • St. Pölten, Lower Austria, Austria, 3100
      • Recruiting
      • Sankt Pölten University of Applied Sciences
      • Contact: Birgit Bauer, Dr.; Phone Number: +43/2742/313 228 371; Email: birgit.bauer@fhstp.ac.at
      • Contact: Gabriele Permoser; Phone Number: +43/676/847 228 286; Email: gabriele.permoser@fhstp.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training program and nutrition therapy; The intervention group receive the GLA:D® training program for 6 weeks and a nutrition therapy for 9 months.	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.; Other: Nutrition therapy; Nutrition therapy based on the New Nordic Diet
Active Comparator: Training program; The control group receive GLA:D® training program for 6 weeks and general information regarding a healthy life style for 9 months.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: St. Pölten University of Applied Sciences
• Collaborators: University of Vienna; Danube University Krems

Study record dates

Study Major Dates

• Study Start (Estimated): January 6, 2024
• Primary Completion (Estimated): April 2, 2024
• Study Completion (Estimated): March 2, 2025

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Osteoarthritis; Quality of life; Nutrition; Knee; Exercise therapy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: NUMOQUA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No