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Recruiting NCT06084949

Effect of Structured Exercise in Patients With Knee Osteoarthritis

No phase Interventional Osteoarthritis, Knee Physical Inactivity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nordic walking or inspiratory muscle training.
Who it may be relevant to
Registry conditions: Osteoarthritis, Knee, Physical Inactivity. Basic parameters: from 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Nordic Walking and Inspiratory Muscle Training to Promote Cardiopulmonary Function in Patients With Knee Osteoarthritis

Overview

The aim of this randomized controlled trial is to evaluate the effect of Nordic walking and inspiratory muscle training (IMT) on cardiopulmonary function in patients with knee osteoarthritis (OA). Mild-to-moderate knee OA patients are randomly allocated into Experimental group (Nordic walking plus routine management) or Control group (Routine management). While End-stage knee OA patients are randomly allocated into Experimental group (IMT plus pre-operative rehabilitation exercise) or Control group (Pre-operative rehabilitation exercise). Participants are invited to undergo two assessments, including baseline assessment, post-intervention assessment. Researchers will compare two groups to see if the cardiopulmonary function can be improved after intervention.

Detailed description

This study recruits patients with different stages and assigns them into different interventions and comparing the effect with those not receiving intervention. It will provide the evidence in terms of the exercise that can promote cardiopulmonary function and at the same time reduce pain and disability for patients with different stages of knee osteoarthritis.

Interventions

  • Device Nordic walking or inspiratory muscle training
    Nordic walking is a form of low-impact aerobic exercise that incorporates the use of walking poles. And inspiratory muscle training is a type of exercise that provides resistance during the inhalation phase.

Primary outcome measures

  • The six-minute walk test [Time frame: Baseline, up to 8 weeks]
  • 30-sec chair stand test [Time frame: Baseline, up to 8 weeks]
  • Grip strength [Time frame: Baseline, up to 8 weeks]
  • Timed up-and-go test [Time frame: Baseline, up to 8 weeks]
  • Quadriceps strength [Time frame: Baseline, up to 8 weeks]
Secondary outcome measures (12)
  • Forced vital capacity [Time frame: Baseline, up to 8 weeks]
  • Forced expiratory volume at first second [Time frame: Baseline, up to 8 weeks]
  • Maximum voluntary ventilation [Time frame: Baseline, up to 8 weeks]
  • Inspiratory muscle strength [Time frame: Baseline, up to 8 weeks]
  • Inspiratory muscle endurance [Time frame: Baseline, up to 8 weeks]
  • Quadriceps muscle oxygenation [Time frame: Baseline, up to 8 weeks]
  • Multidimensional Fatigue Inventory [Time frame: Baseline, up to 8 weeks]
  • Medical Research Council scale [Time frame: Baseline, up to 8 weeks]
  • Physical Activity Scales for the Elderly [Time frame: Baseline, up to 8 weeks]
  • Actigraph [Time frame: Baseline, up to 8 weeks]
  • Pittsburgh Sleep Quality Index [Time frame: Baseline, up to 8 weeks]
  • Western Ontario and McMaster Universities Osteoarthritis Index [Time frame: Baseline, up to 8 weeks]

Eligibility criteria

Inclusion criteria

  • pain on the most days in one or both knees in the past month;
  • difficulty with at least one of daily living activities measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale;
  • radiographic evidence of knee OA in the tibial-femoral compartment (Kellgren and Lawrence grade, K/L ≥1, K/L 1-3 regarded as mild-to-moderate knee OA, others waiting for knee arthroplasty regarded as end-stage knee OA);
  • with normal or corrected visual and auditory function and walking unaided;
  • primary knee OA for more than 6 months, be stable on medication for at least 3 weeks.

Exclusion criteria

  • knee surgery priorly;
  • have steroid injection in previous three weeks;
  • have inflammatory arthritis (e.g., rheumatoid); or unstable angina, or myocardial infarction, or cardiac surgery; or stroke; or treatment with steroids, hormones, or cancer chemotherapy; or pulmonary diseases (force vital capacity<80% of predicted and/or forced expiratory volume at first second<70% of predicted); or a history of exercise-induced asthma;
  • unable to understand the procedure and potential risks of the study;
  • medically unstable that indicate unsafe to participate in exercise test

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The Hong Kong Polytechnic University — Kowloon City

Identifiers

NCT: NCT06084949 · HSEARS20230703001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗