High Intensity Interval Training in Osteoarthritis, Effects on Metabolomics

NCT ID: NCT03039452

Last Updated: 2017-10-31

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

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-10-31

Brief Summary

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Purpose: The purpose of this study will be to examine the feasibility and acceptability of a 6-week high intensity interval training (HIIT) program in patients with knee OA symptoms ranging from mild to severe. A secondary purpose will be to evaluated changes in whole body metabolism induced by 6-weeks of HIIT.

Participants: Fifteen patients (age 40-70 yrs; BMI 20-35 kg/m²) with symptomatic knee OA

Procedures (methods): All participants will be assigned to the single-arm of the study in which all participants will receive 6 weeks of HIIT, delivered twice per week. Outcomes will be assessed at baseline and 6 weeks. The primary outcome will evaluate tolerability, feasibility, acceptability, compliance, and adherence to the HIIT program. Secondary outcomes will include whole body metabolism markers, inflammation, and a set of physical function including knee osteoarthritis symptomatic burden and pain, cardiorespiratory fitness, isometric knee extensor and flexor strength (factors associated with physical function and symptomatic knee OA progression), and body composition.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High intensity interval training

Group Type EXPERIMENTAL

High intensity interval training

Intervention Type BEHAVIORAL

Each training session will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Interventions

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High intensity interval training

Each training session will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Intervention Type BEHAVIORAL

Other Intervention Names

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Stationary bike

Eligibility Criteria

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Inclusion Criteria

* Must exhibit symptomatic knee OA (WOMAC \> 31), radiographic evidence of tibiofemoral OA (2-4 Kellgren-Lawrence scale)
* Age 40-70 years
* Body mass index 20-35 kg/m²
* Cleared by study physician from 12 lead EKG and medical history review

Exclusion Criteria

* Individuals diagnosed with a cardiovascular condition restricting exercise Individuals currently meeting Department of Health and Human Services Guidelines for Physical Activity (meeting \>150 minutes of exercise per week)
* Individuals currently doing HIIT
* Individuals currently participating in physical therapy for knee OA
* Individuals currently participating in another OA intervention study
* Received a corticosteroid or hyaluronic acid injection involved in the knee in the previous 3 weeks or scheduled for during the intervention
* Diagnosis of gout in the knee
* Diagnosis of Rheumatoid arthritis
* Diagnosis of Fibromyalgia
* Other systemic rheumatic disease
* Severe dementia or other memory loss
* Active diagnosis of psychosis or uncontrolled substance abuse disorder
* Hospitalization for a stroke, heart attack, or heart failure, or had surgery for blocked arteries in the past 6 months
* Diabetics (medications include exogenous insulin)
* Total joint replacement knee surgery, other knee surgery, meniscus tear, or ACL tear in the past 12 months
* On a waiting list for total joint replacement
* Severely impaired hearing or speech
* Pregnant or planning to become pregnant in the next 8 weeks
* Inability to speak English
* Serious or terminal illness as indicated by referral to hospice or palliative care
* Nursing home residence
* Inability to ride a stationary bike
* Any other health problems that would prohibit safe participation in the study.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abbie Smith-Ryan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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Applied Physiology Laboratory

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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Smith-Ryan AE, Blue MNM, Anderson KC, Hirsch KR, Allen KD, Huebner JL, Muehlbauer MJ, Ilkayeva OR, Kraus VB, Kraus WE, Golightly YM, Huffman KM. Metabolic and physiological effects of high intensity interval training in patients with knee osteoarthritis: A pilot and feasibility study. Osteoarthr Cartil Open. 2020 Jun 10;2(4):100083. doi: 10.1016/j.ocarto.2020.100083. eCollection 2020 Dec.

Reference Type DERIVED
PMID: 36474875 (View on PubMed)

Other Identifiers

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1P2CHD086851-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16-0829

Identifier Type: -

Identifier Source: org_study_id