Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000079448p
Ethics application status
Submitted, not yet approved
Date submitted
7/01/2025
Date registered
24/01/2025
Date last updated
24/01/2025
Date data sharing statement initially provided
24/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the musculoskeletal and cardiorespiratory effects of a 6-week weighted walking program in nature: a non-randomised, pre-post intervention study in physically active adults.
Scientific title
Musculoskeletal and cardiorespiratory adaptations following a six-week weighted walking program for physically active adults aged between 18-85 years
Secondary ID [1] 313609 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sarcopenia 336156 0
cardiovascular disease 336155 0
Condition category
Condition code
Cardiovascular 332703 332703 0 0
Normal development and function of the cardiovascular system
Musculoskeletal 332702 332702 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research aims to measure the effects of a six-week weighted walking program on lower limb strength, body composition and aerobic capacity/performance.
The intervention is carrying a weighted backpack while walking 6km twice per week under the supervision of a qualified exercise physiologist. each session is expected to take 60-90 minutes to complete.
The weight carried will be prescribed based on Leg Press Weight Ratio score (LPWRs), which is determined by dividing maximum weight pushed in the leg press (kg) by participant’s body weight (BW)(kg). Participant LPWR scores will be compared against the American Col-lege of Sports Medicine’s leg press standards by sex and age (ASCM, 2022, p98). The carrying load prescribed for participants will be based on their LPWR, as follows:
• participants in the below average category (<50% LPWR by age and sex) will be prescribed 10%BW,
• participants in the average category (51-75% LPWR by age and sex) will be prescribed 12.5%BW, and
• participants in the above average category (>80% LPWR by age and sex) will initially carry 15%BW.

Participants will participate in two supervised group walks per week at the Tahbilk eco-trail (6kms) in Nagambie, Victoria, for a period of 6 weeks. session attendance will be recorded tom monitor adherence.
Intervention code [1] 330205 0
Lifestyle
Comparator / control treatment
Participants will act as their own control with a 2 week control treatment involving unweighted walking to be performed prior to the weighted 6 week intervention period.
Unweighted walking will involve walking 6km twice per week under the supervision of a qualified exercise physiologist. each session is expected to take 60-90 minutes to complete.
Participants will participate in two supervised group walks per week at the Tahbilk eco-trail (6kms) in Nagambie, Victoria, for a period of 2 weeks. session attendance will be recorded tom monitor adherence.
Control group
Active

Outcomes
Primary outcome [1] 340232 0
Lower limb strength
Timepoint [1] 340232 0
pre control (baseline week 0), post control completion (week 2) and post intervention completion (week 8)
Primary outcome [2] 340386 0
Lower limb power
Timepoint [2] 340386 0
pre control (baseline week 0), post control completion (week 2) and post intervention completion (week 8)
Secondary outcome [1] 443437 0
body composition consisting of body fat % and lean mass %
Timepoint [1] 443437 0
pre control (baseline week 0), post control completion (week 2) and post intervention completion (week 8)
Secondary outcome [2] 443438 0
aerobic capacity
Timepoint [2] 443438 0
pre control (baseline week 0), post control completion (week 2) and post intervention completion (week 8)

Eligibility
Key inclusion criteria
Participants eligible for the study will be physically active adults (18-64 years) and older adults (65 years +), with no medical contra-indication to perform exercise, including musculoskeletal, neurological or cardiorespiratory illness. Participants will currently meet the National Physical Activity Guidelines for aerobic fitness (i.e. 75 min of vigorous exercise or 150 min of moderate intensity exercise or an equivalent combination of moderate-vigorous exercise per week),
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who have participated in resistance training two or more times per week within three months prior to the study will be excluded. Participants will be excluded if they present with a medical contra-indication to perform exercise, including musculoskeletal, neurological or cardiorespiratory illness.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/02/2025
Actual
Date of last participant enrolment
Anticipated
26/05/2025
Actual
Date of last data collection
Anticipated
25/08/2025
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318080 0
Commercial sector/Industry
Name [1] 318080 0
Span Health Pty Ltd
Country [1] 318080 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 320434 0
Commercial sector/Industry
Name [1] 320434 0
Span Health Pty Ltd
Address [1] 320434 0
Country [1] 320434 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316727 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 316727 0
Ethics committee country [1] 316727 0
Australia
Date submitted for ethics approval [1] 316727 0
20/01/2025
Approval date [1] 316727 0
Ethics approval number [1] 316727 0
HEC25026

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

Contacts
Principal investigator
Name 138810 0
Dr Chris van der Poel
Address 138810 0
Health Sciences 2, Room 421, La Trobe University, Kingsbury Drive, Melbourne Victoria 3086 Australia
Country 138810 0
Australia
Phone 138810 0
+61 03 9479 5166
Fax 138810 0
Email 138810 0
[email protected]
Contact person for public queries
Name 138811 0
Chris van der Poel
Address 138811 0
Health Sciences 2, Room 421, La Trobe University, Kingsbury Drive, Melbourne Victoria 3086 Australia
Country 138811 0
Australia
Phone 138811 0
+61 03 9479 5166
Fax 138811 0
Email 138811 0
[email protected]
Contact person for scientific queries
Name 138812 0
Chris van der Poel
Address 138812 0
Health Sciences 2, Room 421, La Trobe University, Kingsbury Drive, Melbourne Victoria 3086 Australia
Country 138812 0
Australia
Phone 138812 0
+61 03 9479 5166
Fax 138812 0
Email 138812 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case-by-case basis at the discretion of Primary Sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?
• After de-identification, all of the individual participant data collected during the trial will be shared

What types of analyses could be done with individual participant data?
• any purpose

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• access subject to approvals by Principal Investigator (Chris van der Poel, [email protected])

Are there extra considerations when requesting access to individual participant data?
No


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.