Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000159459
Ethics application status
Approved
Date submitted
2/03/2007
Date registered
6/03/2007
Date last updated
19/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of a progressive walking program and glucosamine supplementation in persons with symptoms of knee or hip osteoarthritis.
Scientific title
Effectiveness of a walking program and intake of glucosamine sulphate for reducing pain and stiffness and increasing flexibility and functional ability in persons with early symptoms of hip or knee osteoarthritis.
Secondary ID [1] 287945 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee or hip osteoarthritis 1661 0
Condition category
Condition code
Musculoskeletal 1766 1766 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
18-week, unsupervised home-based progressive walking program performed at the convenience of paticipants schedule.
18-week oral glucosamine sulphate supplementaion (1500 mg daily).
Participants were recruited from the Greater Brisbane area through flyers, television, radio, surveys and various seniors' events.

Feasibility trial.
No control group.
Two treatment groups:

Group 1: 18-week walking program, 3 days per week, starting with 1500 steps in the first week and finishing with 6000 steps by week 18, and 18-week oral glucosamine sulphate supplementation (1500 mg daily)

Group 2: 18-week walking program, 5 days per week, starting with 1500 steps in the first week and finishing with 6000 steps by week 18, and 18-week oral glucosamine sulphate supplementation (1500 mg daily)
Intervention code [1] 1626 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Active

Outcomes
Primary outcome [1] 2471 0
Pain is measured with the self-report Western Ontario and McMaster Universities (WOMAC) pain subscale . Questionnaire is administered at rest, and following completion of a self-paced stepping test (SPS).
Timepoint [1] 2471 0
At baseline, 6, 12, 18, and 24 weeks.
Primary outcome [2] 2472 0
Physical function is assessed by time taken to complete the SPS and scores on the Western Ontario and McMaster Universities (WOMAC) physical function subscale
Timepoint [2] 2472 0
At baseline, 6, 12, 18, and 24 weeks.
Primary outcome [3] 2473 0
Stiffness is measured using the Western Ontario and McMaster Universities (WOMAC) stiffness subscale.
Timepoint [3] 2473 0
At baseline, 6, 12, 18, and 24 weeks.
Secondary outcome [1] 4237 0
Phyiscal activity levels using Active Australia survey.
Psychosocial measures are measured (Arthritis Self-efficacy Scale, Physical Activty Benefits and Barriers Scale, Goldberg Depression and Anxiety Scale, Physical Activity Self-regulation Scale).
Timepoint [1] 4237 0
Baseline, 6, 12, 18, and 24 weeks.
Secondary outcome [2] 4238 0
Pedometers measuring daily step counts
Completion of weekly log sheets to assess compliance with walking program and to track glucosamine sulphate supplementation and medication usage.
General feedback on satisfaction with and perceptions of the walking program as recorded by open-ended questions.
Timepoint [2] 4238 0
6, 12, 18, and 24 weeks.

Eligibility
Key inclusion criteria
Experience pain in at least one knee or hip, - Experience morning stiffness in that knee or hip in the past month- Experience difficulty with performing activities of daily living such as rising from a chair, getting out of bed and other self-care activities- Plan to live in the Greater Brisbane area over the next 6 months- Not exercising more than 60 mins per week- Not allergic to shellfish.
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Corticosteroid or viscosupplement injections in the previous 3 months- Secondary forms of OA in the study knee or hip- Chondrocalcinosis in the study knee or hip- Concomitant inflammatory arthritis or metabolic arthritis- Infected knees or hips- Having a co-morbidity precluding safe involvement in exercise - Living in a dependent environment such as a nursing home- Participation in another research study- Plans for surgery during the study period- For women, pregnant or planning to become pregnant over the next year- Receiving psychiatric or psychological treatment (counselling or pharmacological)- The inability to walk at least 15 minutes continuously.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/08/2006
Actual
14/08/2006
Date of last participant enrolment
Anticipated
Actual
31/12/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
78
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1918 0
University
Name [1] 1918 0
University of Queensland's Joint Research Scholarship
Country [1] 1918 0
Australia
Funding source category [2] 1919 0
University
Name [2] 1919 0
University of Queensland Early Career Grant
Country [2] 1919 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
The University of Queensland
Brisbane QLD 4072 Australia
Country
Australia
Secondary sponsor category [1] 1730 0
None
Name [1] 1730 0
n/a
Address [1] 1730 0
Country [1] 1730 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3566 0
School of Human Movement Studies,University of Queensland
Ethics committee address [1] 3566 0
Ethics committee country [1] 3566 0
Australia
Date submitted for ethics approval [1] 3566 0
Approval date [1] 3566 0
03/03/2006
Ethics approval number [1] 3566 0
HMS06/0304

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27560 0
Dr Norman Ng
Address 27560 0
School of Human Movement and Nutrition Sciences (#26B)
University of Queensland, Blair Drive,
St Lucia, QLD 4072
Country 27560 0
Australia
Phone 27560 0
+61 7 33469710
Fax 27560 0
Email 27560 0
[email protected]
Contact person for public queries
Name 10815 0
Dr Kristi Heesch
Address 10815 0
Queensland University of Technology
School of Public Health and Social Work
Country 10815 0
Australia
Phone 10815 0
+61 7 31385460
Fax 10815 0
Email 10815 0
[email protected]
Contact person for scientific queries
Name 1743 0
Norman Ng
Address 1743 0
School of Human Movement and Nutrition Sciences (#26B)
University of Queensland, Blair Drive,
St Lucia, QLD 4072
Country 1743 0
Australia
Phone 1743 0
+61 7 33469710
Fax 1743 0
Email 1743 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.