Tolerability of High Intensity Exercise for Knee Osteoarthritis

NCT05777564 | Completed DMC

• 1 other identifier: H-22064954
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Current knee osteoarthritis (OA) guidelines recommend knee specific exercise as treatment for knee OA pain. However, up to 87 % of patients with knee OA have at least one other chronic condition, typically cardiovascular in nature. The elevated risk of cardiovascular health problems can be mitigated by performing aerobic exercise. By consequence, it seems logical to apply aerobic exercise for this patient group as the symptomatic benefit is equal to other types of exercise. Aim: This study aims to assess the tolerability of cardiovascular exercise using High Intensity Interval Training (HIIT) on different self-selected exercise equipment in patients with knee OA and at least one CVD risk factor. Hypothesis: The hypothesis is that performing HIIT exercise is tolerable when having knee OA and at least one CVD risk factor. Method: The study is a prospective cohort study designed to assess if HIIT performed by patients with knee OA and at least one modifiable CVD risk factor influence knee pain. The investigators plan to include 40 participants. The participants will be recruited from the osteoarthritis outpatient clinic at Bispebjerg-Frederiksberg hospital. This study will include participants with a clinical diagnosis of knee OA (either one or both knees) and at least one CVD risk factor (obesity, hypertension, elevated HbA1c (long-term blood glycose), elevated triglycerides, elevated cholesterol (LDL)). All participants will attend the HIIT intervention 3 times per week, for 12 weeks. Before a participant attend their first exercise session, he/she will be asked to complete an educational session about knee OA and aerobic exercise. Participants will have a pre-screening visit (phone call), a screening visit, and a baseline visit, before the 12-week exercise period (3 sessions weekly), and after completion of the exercise period a follow-up visit. Finance: This study is fully funded by Sygesikring "Denmark". Publication: All results, both negative, positive, and inconclusive will be published. Should publication fail, the results will be made publicly available.

Conditions

Knee Osteoarthritis; Cardiovascular Diseases

Keywords

knee osteoarthritis; cardiovasculare diseases; aerobic exercise; tolerance

Outcome Measures

Primary Outcomes (3)

• Knee flares

  number of knee flares reported during the exercise period, a flare is defined at an increase of minimum 2 on a numeric rating scale from 0-10

  from exercise week 1-12

• Average knee pain

  reported average knee pain from first to last exercise session on a numeric rating scale from 0-10

  from exercise week 1-12

• Attendance

  number of attended sessions during the exercise period

  from exercise week 1-12

Secondary Outcomes (10)

• Completion of the HIIT protocol

  from exercise week 1-12

• Cardiopulmonary test (Vo2peak)

  at baseline (week 0) and after completion of the exercise period (week 13)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  baseline (week 0) and follow-up (week 13)

• PainDETECT Questionnaire

  baseline (week 0)

• Blood sample (cholesterol)

  baseline (week 0) and follow-up (week 13)

Study Arms (1)

HIIT for knee OA

OTHER

high intensity exercise

Other: High intensity exercise

Interventions

High intensity exercise OTHER

High intensity exercise on a indoor aerobic exercise device.

HIIT for knee OA

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically diagnosed with knee OA
• At least one of the following CVD risk factors: Overweight/obesity, hypertension, elevated HbA1c, elevated triglycerides, High LDL
• Age \> 18
• Willing and able to understand and participate in the study

You may not qualify if:

• Contraindication to exercise (e.g. resting systolic blood pressure \> 200 or diastolic blood pressure \> 115, acute or reoccurring chest pain)
• Major cardiovascular event within the last 5 years
• Planning to start another treatment for their knee OA during the study participation period
• Performing at least 150 minutes of moderate intensity activities or ≥ 75 minutes of vigorous activity weekly
• Insulin dependent type I or type II diabetes
• Scheduled surgery during study participation
• Evidence of other inflammatory joint disease (e.g., rheumatoid arthritis or gout)
• Generalized pain syndromes such as fibromyalgia
• Lumbar or cervical nerve root compression syndromes
• Other musculoskeletal, neurological, or medical condition precluding participation to aerobic exercise
• Any other condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as a large knee joint effusion, uncontrolled diabetes/hypertension, psychiatric disorders, or opiate dependency.

Sponsors & Collaborators

• Frederiksberg University Hospital: lead

Study Sites (1)

The Parker Insitute

Frederiksberg, 2770, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Cardiovascular Diseases

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Cecilie Bartholdy, PhD

  The Parker Institute, Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Doc

Model Details: prospective study design

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 21, 2023
• Study Start: March 28, 2023
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The SAP will become available at clincialtrials.gov before last patient last visit. The study protocol will be available if requested. Upon reasonable request from other researchers, addition data will be made available.
• Access Criteria: The request must be from an established research group. Approved ethical and data management documents must obtained before data sharing is accommodated.

Locations

DK (1)