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

Primary Purpose

Osteo Arthritis Knee

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Training program
Nutrition therapy
Sponsored by
St. Pölten University of Applied Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Knee, Osteoarthritis, Exercise therapy, Nutrition, Quality of life

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sankt Pölten University of Applied SciencesRecruiting
  • St. Poelten University of Applied SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Training program and nutrition therapy

Training program

Arm Description

The intervention group receive the GLA:D® training program for 6 weeks and a nutrition therapy for 9 months.

The control group receive GLA:D® training program for 6 weeks and general information regarding a healthy life style for 9 months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 5, 2023
Last Updated
October 23, 2023
Sponsor
St. Pölten University of Applied Sciences
Collaborators
University of Vienna, Danube University Krems
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1. Study Identification

Unique Protocol Identification Number
NCT05955300
Brief Title
Nutrition and Movement to Improve Quality of Life With Knee Osteoarthritis
Acronym
NUMOQUA
Official Title
Evidence Based Training Program Combined With Nutrition Therapy for Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2023 (Anticipated)
Primary Completion Date
April 2, 2024 (Anticipated)
Study Completion Date
March 2, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Pölten University of Applied Sciences
Collaborators
University of Vienna, Danube University Krems

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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 To evaluate the effect of a nutrition therapy combined with exercise therapy on QL in patients knee OA 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
Knee, Osteoarthritis, Exercise therapy, Nutrition, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Clinical trial with 2 groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Training program and nutrition therapy
Arm Type
Experimental
Arm Description
The intervention group receive the GLA:D® training program for 6 weeks and a nutrition therapy for 9 months.
Arm Title
Training program
Arm Type
Active Comparator
Arm Description
The control group receive GLA:D® training program for 6 weeks and general information regarding a healthy life style for 9 months.
Intervention Type
Other
Intervention Name(s)
Training program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Nutrition therapy
Intervention Description
Nutrition therapy based on the New Nordic Diet
Primary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score (Quality of Life)
Description
Patient reported outcome measurement, Max: 100, Min: 0, Max is the best that can be achieved
Time Frame
9 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Wondrasch, PhD
Phone
+436504108196
Email
barbara.wondrasch@fhstp.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Chmelar, MSc
Email
sabine.chmelar@fhstp.ac.at
Facility Information:
Facility Name
Sankt Pölten University of Applied Sciences
City
St. Pölten
State/Province
Lower Austria
ZIP/Postal Code
3100
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriele Permoser
Phone
+43/676/847 228 286
Email
gabriele.permoser@fhstp.ac.at
First Name & Middle Initial & Last Name & Degree
Birgit Bauer, Dr.
Phone
+43/2742/313 228 371
Email
birgit.bauer@fhstp.ac.at
Facility Name
St. Poelten University of Applied Sciences
City
St. Poelten
ZIP/Postal Code
3100
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Wondrasch, PhD
Phone
+436504108196
Email
barbara.wondrasch@fhstp.ac.at
First Name & Middle Initial & Last Name & Degree
Sabine Chmelar, MSc
Email
sabine.chmelar@fhstp.ac.at

12. IPD Sharing Statement

Plan to Share IPD
No

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Nutrition and Movement to Improve Quality of Life With Knee Osteoarthritis

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