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

Sponsor
St. Pölten University of Applied Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05955300
Collaborator
University of Vienna (Other), Danube University Krems (Other)
60
2
2
17
30
1.8

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Other: GLAD training program in combination with nutrition therapy based on the New Nordic Niet
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Clinical trial with 2 groupsClinical trial with 2 groups
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evidence Based Training Program Combined With Nutrition Therapy for Patients With Knee Osteoarthritis
Anticipated Study Start Date :
Oct 2, 2023
Anticipated Primary Completion Date :
Apr 2, 2024
Anticipated Study Completion Date :
Mar 2, 2025

Arms and Interventions

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: GLAD training program in combination with nutrition therapy based on the New Nordic Niet
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.

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: GLAD training program in combination with nutrition therapy based on the New Nordic Niet
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.

Outcome Measures

Primary Outcome Measures

  1. Knee Injury and Osteoarthritis Outcome Score (Quality of Life) [9 Month]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sankt Pölten University of Applied Sciences St. Pölten Lower Austria Austria 3100
2 St. Poelten University of Applied Sciences St. Poelten Austria 3100

Sponsors and Collaborators

  • St. Pölten University of Applied Sciences
  • University of Vienna
  • Danube University Krems

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
St. Pölten University of Applied Sciences
ClinicalTrials.gov Identifier:
NCT05955300
Other Study ID Numbers:
  • NUMOQUA
First Posted:
Jul 21, 2023
Last Update Posted:
Jul 21, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by St. Pölten University of Applied Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2023