Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001127897
Ethics application status
Approved
Date submitted
22/10/2012
Date registered
23/10/2012
Date last updated
2/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of pole walking on functional abilities and psychosocial wellbeing in older adults: A randomized controlled trial
Scientific title
The effect of moderate intensity pole walking and regular walking on functional and psychosocial health in older adults: a randomized controlled trial
Secondary ID [1] 281401 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional measures 287640 0
psycho social measures 287641 0
joint pain 287642 0
physical activity levels 287643 0
Condition category
Condition code
Physical Medicine / Rehabilitation 287974 287974 0 0
Other physical medicine / rehabilitation
Mental Health 287975 287975 0 0
Studies of normal psychology, cognitive function and behaviour
Musculoskeletal 287976 287976 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of a pole walking program in which participants will walk with poles, similar to cross country ski poles. Each site will have one group of 10 pole walkers. The intervention group will exercise outdoors for up to 60 minutes, 3 times weekly, for 12 weeks. Intensity will be self-assessed during the exercise sessions using the Borg scale at a level of 3-4 (“moderate”). Qualified exercise instructors who have undergone training in the pole walking technique will instruct the PW participants in the first session, and subsequently supervise all pole walking exercise sessions.
Intervention code [1] 285888 0
Prevention
Intervention code [2] 285915 0
Lifestyle
Intervention code [3] 285916 0
Treatment: Other
Comparator / control treatment
The comparator program is a walking program in which participants will walk without poles. The program will be identical to the pole walking program, as follows: Each site will have one group of 10 walkers. The group will exercise outdoors for up to 60 minutes, 3 times weekly, for 12 weeks. Intensity will be self-assessed during the exercise sessions using the Borg scale at a level of 3-4 (“moderate”). Qualified exercise instructors will supervise all walking exercise sessions.
Control group
Active

Outcomes
Primary outcome [1] 288186 0
Functional fitness, as measured b the Senior Fitness Test
Timepoint [1] 288186 0
12 weeks
Secondary outcome [1] 299574 0
Quality of Life as measured by the SF-12
Timepoint [1] 299574 0
12 weeks
Secondary outcome [2] 299575 0
Vitality, as measured by the Vitality plus scale
Timepoint [2] 299575 0
12 weeks
Secondary outcome [3] 299576 0
Social support, as measured by the Broadhead 8-item scale
Timepoint [3] 299576 0
12 weeks
Secondary outcome [4] 299577 0
Physical activity, as measured by accelerometry, the Active Australia Survey, and the 5-domain sitting questionnaire
Timepoint [4] 299577 0
12 weeks
Secondary outcome [5] 299578 0
Pain, as measured by the Numerical Rating Scale
Timepoint [5] 299578 0
12 weeks

Eligibility
Key inclusion criteria
older adults
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exercising over 150 mins per week over 5 or more days in the previous week, medical approval to participate in a walking programme denied, unable to speak or understand English , having a shoulder and elbow flexion range of motion (ROM) of less than 90 degrees, having pathological conditions of the upper extremity.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
60 participants will be recruited from four senior living facilities at different geographic locations. Initial phone contact to the organisations will be followed by an email or letter that will be given to organisation leaders to introduce the study and the lead researcher. “Active Aging” seminars will be offered to the residents at the facilities through the facility gatekeepers . The seminars will consist of presentation of information and discussion on the benefits of physical activity for aging. Participants will be recruited through the seminars at the senior living facilities . An opportunity for participants to join the study will be presented at the end of the seminars. An information brochure, with inclusion and exclusion criteria, will be given to all participants in the seminar. Interested individuals will be asked to contact (telephone or email) the project supervisor who will provide additional written information on the background and aim of the study, the study protocol, and the personal costs and benefits for the participants. Respondents will be screened to ascertain medical eligibility by using the Australian College of Sports Medicine Pre-exercise screening tool. Potential participants will be assessed in an initial testing session at a convenient indoor location to the participants. Prior to any data collection, individuals will receive both verbal and written information about the study. Prior to enrollment in the study, participants will be asked to sign a consent form indicating their understanding of study requirements. They also should be willing to be randomised to participate in one of two 12 week groups targeting walking during the working day. Testing sessions will be conducted using trained assessors who are not aware of participants’ groups in an individual baseline test session before the trial commences. Allocation concealment will be done as follows: Participants in each location will be randomized into either a pole walking group or a walking group using cental randomisation by computer. The statistical computer program SPSS will be used to randomly assign participants at each of the four intervention sites into the pole walking or the walking group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The statistical computer program SPSS will be used to randomly assign participants at each of the three intervention sites into the pole walking group (n=10) or the walking group (n=10).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
3 sites will be used, with each site hosting two groups of participants, one a pole walking group, and one a walking group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/03/2013
Actual
14/05/2013
Date of last participant enrolment
Anticipated
28/06/2013
Actual
28/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5955 0
United States of America
State/province [1] 5955 0
Kentucky

Funding & Sponsors
Funding source category [1] 286158 0
University
Name [1] 286158 0
University of Queensland
Country [1] 286158 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
St Lucia, 4072
Brisbane QLD
Country
Australia
Secondary sponsor category [1] 284968 0
None
Name [1] 284968 0
Address [1] 284968 0
Country [1] 284968 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288258 0
University of Queensland ethics committee
Ethics committee address [1] 288258 0
Ethics Officer
Research & Innovation Division
Cumbrae-Stewart Building (72)
THE UNIVERSITY OF QUEENSLAND, St Lucia, 4072
Brisbane
QLD
Ethics committee country [1] 288258 0
Australia
Date submitted for ethics approval [1] 288258 0
27/10/2012
Approval date [1] 288258 0
13/12/2012
Ethics approval number [1] 288258 0

Summary
Brief summary
60 participants over 65 years old will be recruited from four senior independent living facilities. They will undergo a pre-exercise test session. In it they will complete a a self administered questionnaire which will include questions on general health and wellbeing, physical activity levels, joint pain levels, sitting behaviours, vitality, and social support. Measurements of blood pressure, height, weight, and waist circumference, hand grip strength will be taken. Functional fitness tests will be administered which will include a 30-second chair-stand test, a 30-second arm-curl test, a 3 meter, up-and go test, and a 6-minute walk test. Daily physical activity levels will be recorded and measured by a small activity monitoring device (accelerometer) worn during 5 consecutive week days by participants. In addition, subjects will fill in a brief activity diary to verify the time the accelerometers were worn. The participants will then be randomised into two groups of up to 8 participants per site. Both groups will exercise outdoors for up to 60 minutes, 3 times weekly, for 12 weeks at a moderate intensity. Exerstrider (registered trademark) walking poles and walking technique will be used in the experimental group. Following the 12 week exercise period, a post exercise test consisting of the same measures as the pre-test will be undertaken.
Trial website
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 34838 0
Ms Juliette Fritschi
Address 34838 0
C/O School of Human Movement Studies
The University of Queensland
St Lucia, QLD 4072
Country 34838 0
Australia
Phone 34838 0
+61, 7, 3365 6240
Fax 34838 0
Email 34838 0
[email protected]
Contact person for public queries
Name 18085 0
Ms Juliette Fritschi
Address 18085 0
The School of Human Movement Studies
Level 5, Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country 18085 0
Australia
Phone 18085 0
+61 7 3365 6240
Fax 18085 0
+61 7 3365 6877
Email 18085 0
[email protected]
Contact person for scientific queries
Name 9013 0
Ms Juliette Fritschi
Address 9013 0
The School of Human Movement Studies
Level 5, Human Movement Studies Building (26B), Blair Drive
The University of Queensland
St Lucia QLD 4072
Country 9013 0
Australia
Phone 9013 0
+61 7 3365 6240
Fax 9013 0
+61 7 3365 6877
Email 9013 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
SourceTitleYear of PublicationDOI
EmbaseOn your feet: protocol for a randomized controlled trial to compare the effects of pole walking and regular walking on physical and psychosocial health in older adults.2014https://dx.doi.org/10.1186/1471-2458-14-375
N.B. These documents automatically identified may not have been verified by the study sponsor.