search
Back to results

Efficacy of Exercise on Quality of Life and Physical Function in Patients With Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Pain

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Strength training
Aerobic exercise
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Pain, Exercise, Function, Cartilage quality

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Women and men aged 35-70 years
  • Clinical knee OA according to the American College of Rheumatology Clinical Criteria
  • Kellgren and Lawrence radiographic OA grade 2 and 3 (mild to moderate radiographic OA)

Exclusion Criteria:

  • Severe knee OA according to the Kellgren and Lawrence classification (grade 4)
  • Other known major musculoskeletal impairments in the lower extremities or the back or prostheses in any joint of the lower extremities
  • Known coronary heart diseases or cancer
  • Body mass index > 35
  • Scheduled for surgery in any joint
  • Known mental or psychologic diseases
  • Known drug abuse
  • Persons who already perform sports related moderate physical activity more than two times a week
  • Contraindications for magnetic resonance imaging (specific point list at Oslo University Hospital, radiographic department)
  • Not speaking Norwegian language

Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Strength training

Aerobic exercise

Control group

Arm Description

The strength group include progressive strength training and neuromuscular exercises. The inclusion will be performed 2-3 times a week for 12 weeks.

The aerobic exercise group will cycle on an ergometer bicycle 2-3 times a week for 12 weeks on moderate loading. The loading will be controlled by a heart rate monitor and is defined as 75% of maximal heart rate (calculated with formula for maximal heart rate reserve).

The control group will do as usual.

Outcomes

Primary Outcome Measures

Knee-related quality of life
Primary outcome for the study will be the quality of life subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) (0-100 scale). 0 is very poor knee-related quality of life, while 100 indicates normal knee-related quality of life.

Secondary Outcome Measures

Knee function
The KOOS is a self-administered knee-specific questionnaire containing 5-item Likert scales on pain, other symptoms, activities of daily living (ADL), function in sports and recreation and knee-related quality of life (QOL). Each scale goes from 0-100, 0 indicating worse function and 100 representing normal function.
Health-related quality of life
Euro Quality of life 5 dimensions 5 level (EQ-5D-5L) will be used to measure health related quality of life. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EuroQol (EQ) Visual analogue scale (VAS) records the patient's self-rated health on a vertical visual analogue scale. This can be used as a quantitative measure of health outcome that reflects the patient's own judgement. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number (utility) reflecting preferability compared to other health profiles.
Radiographic osteoarthritis progression
Conventional x-rays will be used to assess radiographic progression of osteoarthritis

Full Information

First Posted
September 7, 2012
Last Updated
April 13, 2023
Sponsor
Oslo University Hospital
Collaborators
University Hospital, Akershus, Oslo Metropolitan University
search

1. Study Identification

Unique Protocol Identification Number
NCT01682980
Brief Title
Efficacy of Exercise on Quality of Life and Physical Function in Patients With Knee Osteoarthritis
Official Title
Efficacy of Strength and Aerobic Exercise on Patient-reported Outcomes in Patients With Knee Osteoarthritis - A Randomised Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
University Hospital, Akershus, Oslo Metropolitan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The overall contribution of this study is to increase the knowledge of the efficacy of strength and aerobic exercise on knee related quality of life, knee pain, and physical function in patients with knee osteoarthritis (OA). Knee OA is one of the most important diseases within musculoskeletal conditions affecting a considerable number of people worldwide. This randomized controlled trial will involve one intervention group delivered strength exercises and one group delivered aerobic exercise (ergometer cycling). The two intervention groups will be compared to a control group undergoing usual care. Cost-effectiveness analysis will be performed comparing the three groups. The study is funded from The Research Council of Norway.
Detailed Description
The trial aimed to recruit 207 study participants randomly allocated to three arms. The participants had to have symptomatic knee osteoarthritis verified by grade 2-3 using the Kellgren and Lawrence radiographic classification system, and they had to have knee pain most of the days the last month and fulfil 2/3 of the ACR clinical criteria. Participants with other serious comorbidities or self-reported BMI >35 were included. The interventions consisted of structured strength training program over 12-14 weeks, and a structured stationary cycling program for 12-14 weeks. Primary outcome was the KOOS knee-related quality of life subscale at the 1 year follow-up. Secondary outcomes were other patient reported outcomes, muscle strength, and peak oxygen consumption at the 4-month and 1 year follow-up, and over time (1-year).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Pain
Keywords
Osteoarthritis, Pain, Exercise, Function, Cartilage quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
207 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Strength training
Arm Type
Experimental
Arm Description
The strength group include progressive strength training and neuromuscular exercises. The inclusion will be performed 2-3 times a week for 12 weeks.
Arm Title
Aerobic exercise
Arm Type
Experimental
Arm Description
The aerobic exercise group will cycle on an ergometer bicycle 2-3 times a week for 12 weeks on moderate loading. The loading will be controlled by a heart rate monitor and is defined as 75% of maximal heart rate (calculated with formula for maximal heart rate reserve).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will do as usual.
Intervention Type
Other
Intervention Name(s)
Strength training
Intervention Description
The strength training will be delivered 2-3 times per week for 12 weeks, 5-8 repetitions maximum in 3 series. The patients must warm up 5 minutes on an ergometer cycle. The following muscle groups will be trained: Quadriceps and hamstrings, hip muscles (abductors and extensors), calf muscles. A home exercise program will be delivered including one leg exercises and balance exercises. Progression will follow a 2+ principle. For instance, when the study participant is able to perform 2 more repetitions, more loads are required.
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
The aerobic exercise program include ergometer cycling for at least 45 minutes 2-3 times a week on 75-80% of max heart rate will be required.
Primary Outcome Measure Information:
Title
Knee-related quality of life
Description
Primary outcome for the study will be the quality of life subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) (0-100 scale). 0 is very poor knee-related quality of life, while 100 indicates normal knee-related quality of life.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Knee function
Description
The KOOS is a self-administered knee-specific questionnaire containing 5-item Likert scales on pain, other symptoms, activities of daily living (ADL), function in sports and recreation and knee-related quality of life (QOL). Each scale goes from 0-100, 0 indicating worse function and 100 representing normal function.
Time Frame
4 months and 1 year
Title
Health-related quality of life
Description
Euro Quality of life 5 dimensions 5 level (EQ-5D-5L) will be used to measure health related quality of life. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EuroQol (EQ) Visual analogue scale (VAS) records the patient's self-rated health on a vertical visual analogue scale. This can be used as a quantitative measure of health outcome that reflects the patient's own judgement. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number (utility) reflecting preferability compared to other health profiles.
Time Frame
4 months and 1 year
Title
Radiographic osteoarthritis progression
Description
Conventional x-rays will be used to assess radiographic progression of osteoarthritis
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Isokinetic muscle strength
Description
Isokinetic muscle strength will be measured in a Biodex6000 machine. The participants sit in a standardised position and flex/extend their knees at 60 degrees/second. The peak torque value of the five repetitions is recorded.
Time Frame
4 months and 1 year
Title
Maximal oxygen consumption (VO2max)
Description
VO2max is measured using an incremental ramp test procedure on a stationary bike, designed to achieve supramaximal workloads within ~4-6 min. The workload was increased by 25 watts every 30 second to total exhaustion.
Time Frame
4 months and 1 year
Title
Self-efficacy for pain
Description
Arthritis self-efficacy scale (ASES) was included to measure self-efficacy for pain. A modified version of ASES containing 11 questions regarding the patient's certainty to perform various tasks related to pain and symptoms, where each item is rated from 1 (very uncertain) to 5 (very certain) was used.
Time Frame
4 months and 1 year
Title
Total knee replacement
Description
We will register continuously numbers of total knee replacements during the follow-up years.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women and men aged 35-70 years Clinical knee OA according to the American College of Rheumatology Clinical Criteria Kellgren and Lawrence radiographic OA grade 2 and 3 (mild to moderate radiographic OA) Exclusion Criteria: Severe knee OA according to the Kellgren and Lawrence classification (grade 4) Other known major musculoskeletal impairments in the lower extremities or the back or prostheses in any joint of the lower extremities Known coronary heart diseases or cancer Body mass index > 35 Scheduled for surgery in any joint Known mental or psychologic diseases Known drug abuse Persons who already perform sports related moderate physical activity more than two times a week Contraindications for magnetic resonance imaging (specific point list at Oslo University Hospital, radiographic department) Not speaking Norwegian language
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
May Arna Risberg, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0407
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24028201
Citation
Oiestad BE, Osteras N, Frobell R, Grotle M, Brogger H, Risberg MA. Efficacy of strength and aerobic exercise on patient-reported outcomes and structural changes in patients with knee osteoarthritis: study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2013 Sep 12;14:266. doi: 10.1186/1471-2474-14-266.
Results Reference
derived

Learn more about this trial

Efficacy of Exercise on Quality of Life and Physical Function in Patients With Knee Osteoarthritis

We'll reach out to this number within 24 hrs