Nutrition and Movement to Improve Quality of Life With Knee Osteoarthritis

NCT ID: NCT05955300

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-06

Study Completion Date

2025-03-02

Brief Summary

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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

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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

Conditions

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Osteo Arthritis Knee

Keywords

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Knee Osteoarthritis Exercise therapy Nutrition Quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Clinical trial with 2 groups
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Training program and nutrition therapy

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

Group Type EXPERIMENTAL

Training program

Intervention Type OTHER

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

Intervention Type OTHER

Nutrition therapy based on the New Nordic Diet

Training program

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

Group Type ACTIVE_COMPARATOR

Training program

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Nutrition therapy

Nutrition therapy based on the New Nordic Diet

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Vienna

OTHER

Sponsor Role collaborator

Danube University Krems

OTHER

Sponsor Role collaborator

St. Pölten University of Applied Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sankt Pölten University of Applied Sciences

Sankt Pölten, Lower Austria, Austria

Site Status RECRUITING

St. Poelten University of Applied Sciences

Sankt Pölten, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Barbara Wondrasch, PhD

Role: CONTACT

Phone: +436504108196

Email: [email protected]

Sabine Chmelar, MSc

Role: CONTACT

Email: [email protected]

Facility Contacts

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Gabriele Permoser

Role: primary

Birgit Bauer, Dr.

Role: backup

Barbara Wondrasch, PhD

Role: primary

Sabine Chmelar, MSc

Role: backup

References

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Hold E, Chmelar S, Aubram T, Leitner G, Nehrer S, Neubauer O, Wagner KH, Wondrasch B. Nutrition and movement to improve quality of life in patients with knee osteoarthritis: the NUMOQUA study protocol for a randomised controlled trial. Trials. 2024 Apr 9;25(1):245. doi: 10.1186/s13063-024-08048-2.

Reference Type DERIVED
PMID: 38594710 (View on PubMed)

Other Identifiers

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NUMOQUA

Identifier Type: -

Identifier Source: org_study_id