Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000068561
Ethics application status
Approved
Date submitted
9/01/2015
Date registered
23/01/2015
Date last updated
23/01/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Individualised exercise programs for people with osteoarthritis of the knee
Scientific title
Enhancing aerobic fitness using individualized mixed-modality exercise programs for people with osteoarthritis
Secondary ID [1] 285936 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis knee 293864 0
Condition category
Condition code
Musculoskeletal 294168 294168 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 week, 24 session mixed modality exercise program.
Aerobic exercise conducted on treadmills and cycle ergometers; strength training on fixed weight machines.
Aerobic exercise intensity: 60% heart rate reserve.
Duration: 30 minutes per session, one-on-one supervision with a clinical exercise physiologist.
A log of adherence outside of the sessions was not kept.
The clinical exercise physiologist asked questions about general adherence at each session.
Exercise outside of the supervised sessions will be encouraged. The type, duration and frequency will be individualised based on each participant's fitness level and level of disability.
The general recommendation is 30 minutes of aerobic exercise e.g., walking or swimming on days when not attending the clinic.
Intervention code [1] 290913 0
Rehabilitation
Comparator / control treatment
Pre-post comparisons. No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293958 0
Aerobic fitness was assessed wiht submaximal walking (6-minute walk test or Ebbeling treadmill test) or cycling (Astrand-Ryhming test) (chosen according to the subject’s individual limitations and preferences) was performed to assess cardiorespiratory fitness, with prediction equations used to estimate VO2 max
Timepoint [1] 293958 0
End of 12 week trial
Secondary outcome [1] 312232 0
Pain was assessed with subscales from the Short Form 36 (SF-36) Health Survey and the Short Form Arthritis Impact Measurement Scales 2 (AIMS2-SF).
Timepoint [1] 312232 0
End of 12 week period
Secondary outcome [2] 312233 0
Quality of Life measures was assessed with the SF-36 questionnaire.
Timepoint [2] 312233 0
End of 12 week program

Eligibility
Key inclusion criteria
Osteoarthritis knee
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Physical disabilities or co-morbidities preventing exercise or increasing the risks of exercise.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/03/2013
Actual
1/04/2013
Date of last participant enrolment
Anticipated
29/11/2013
Actual
29/11/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 6584 0
New Zealand
State/province [1] 6584 0
Auckland

Funding & Sponsors
Funding source category [1] 290520 0
University
Name [1] 290520 0
University of Auckland
Country [1] 290520 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland
1142
Country
New Zealand
Secondary sponsor category [1] 289214 0
None
Name [1] 289214 0
None
Address [1] 289214 0
N/A
Country [1] 289214 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292170 0
University of Auckland Human Ethics Committee
Ethics committee address [1] 292170 0
Private Bag 92019
Auckland
1142
Ethics committee country [1] 292170 0
New Zealand
Date submitted for ethics approval [1] 292170 0
Approval date [1] 292170 0
21/01/2013
Ethics approval number [1] 292170 0
2013/8844

Summary
Brief summary
Exercise as a management tool for people with osteoarthritis has been mainly studied using randomized clinical trial designs where exercise is delivered in a similar dose, intensity, and type to all participants. The hypothesis we tested was that people with osteoarthritis of the knee improve their aerobic fitness and quality of life as a result of an individualised exercise program. We prescribed aerobic and strength training that was appropriate for each person’s capability, and measured changes in aerobic fitness, pain and quality of life factors. The study outcomes supported the hypothesis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53898 0
Dr James Stinear
Address 53898 0
University of Auckland
Department of Sport and Exercise Science
Private Bag 92019
Auckland
1142
Country 53898 0
New Zealand
Phone 53898 0
+64 9 373 7599 ext 82378
Fax 53898 0
Email 53898 0
[email protected]
Contact person for public queries
Name 53899 0
Dr James Stinear
Address 53899 0
University of Auckland
Department of Sport and Exercise Science
Private Bag 92019
Auckland
1142
Country 53899 0
New Zealand
Phone 53899 0
+64 9 373 7599 ext 82378
Fax 53899 0
Email 53899 0
[email protected]
Contact person for scientific queries
Name 53900 0
Dr James Stinear
Address 53900 0
University of Auckland
Department of Sport and Exercise Science
Private Bag 92019
Auckland
1142
Country 53900 0
New Zealand
Phone 53900 0
+64 9 373 7599 ext 82378
Fax 53900 0
Email 53900 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.