Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000640404p
Ethics application status
Submitted, not yet approved
Date submitted
21/05/2025
Date registered
17/06/2025
Date last updated
17/06/2025
Date data sharing statement initially provided
17/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the Effects of Eccentric Lunge Walking on Physical Fitness, Health, Cognitive Function, and Quality of Life in Older Adults
Scientific title
Characteristics of eccentric lunge walking and its effects on physical fitness, health, cognitive function, and quality of life in older adults aged 60-80 years old
Secondary ID [1] 314495 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 337540 0
Mental Health : Anxiety 337542 0
Insulin sensitivity 337545 0
Depression 337679 0
Condition category
Condition code
Mental Health 333903 333903 0 0
Anxiety
Mental Health 334013 334013 0 0
Depression
Musculoskeletal 334014 334014 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name of intervention:
Eccentric Lunge Walking Program

Intervention description:
An 8-week eccentric lunge walking program for older adults (ages 60-80).

Procedure:
Participants will perform eccentric lunge walking, controlling the lengthening contractions of knee extensor muscles as body weight shifts onto one leg. Participants were allocated to either a High Dose or Low Dose eccentric lunge walking group for an 8-week program. Walking duration gradually increased by 5 minutes every 2 weeks, starting at 10 minutes in Week 1 and reaching 30 minutes by Week 8. The High Dose group aimed to complete up to 20 repetitions (i.e. sets of 10 eccentric lunges) of ~2 minutes each by Week 8, totaling approximately 100 lunges and 20 minutes of lunge activity within the 30-minute session. The Low Dose group aimed for up to 10 repetitions, totaling 30 lunges and 6 minutes of lunge activity within the same timeframe. Participants will perform the sessions independently, five times per week, in a safe, flat environment. Participants will assess their physical fitness, mental health, cognition, bone health, body composition, insulin sensitivity, and quality of life before and after the program.

A 45–60 minute one-on-one familiarization session will be conducted one week prior to the intervention by an exercise science researcher at a safe, flat location. Participants will be taught proper eccentric lunge walking techniques and randomly assigned to either the High-Dose group (greater lunge volume) or Low-Dose group (lower lunge volume). The investigator will provide constructive verbal and video feedback. Participants will first be asked to perform 4 continuous steps; once performed correctly, they will progress to 6 steps, and then to 10 steps upon mastering the technique. During both the familiarization session and the intervention period, participants will be asked to wear non-slip shoes and appropriate exercise attire.

Both groups will perform 10 eccentric lunge steps every 2 minutes while walking at a normal pace. The number of repetitions will vary between the groups.

Expertise of Investigators:
intervention administered by expertise exercise science researchers.

Mode of delivery:
The familiarization session will be delivered face-to-face. Once participants are familiar with the technique, they will be asked to complete the intervention independently. Personalized instruction will be provided during the familiarization session to ensure participants understand the eccentric lunge walking technique.
Participants will complete the exercise at home. For comfort and safety, Advice them to wear comfortable clothes and non-slip shoes. All details will be provided in the Information Sheet and explained during the familiarization session.

Participants will receive two pedometers:
Exercise walking pedometer: Advice them to worn on waist during exercise sessions to measure steps.
Daily activity pedometer: Advice them to worn throughout the day to track steps during everyday activities.
Intervention code [1] 331121 0
Lifestyle
Comparator / control treatment
Control Group: Participants in this group performed a lower number of eccentric lunge walks (low dose). The control group aimed for up to 10 lunge repetitions per set, totaling approximately 30 lunges and 6 minutes of lunge activity within each 30-minute session. The duration of normal walking between sets was longer compared to the treatment group (high dose group), resulting in fewer lunge sets but more walking.
Control group
Dose comparison

Outcomes
Primary outcome [1] 341567 0
Change in physical fitness after eccentric lunge walking intervention.
Timepoint [1] 341567 0
Assessments will be conducted at baseline (before starting the 8-week intervention) and immediately after completing the 8-week intervention (at week 9).
Primary outcome [2] 341569 0
Change in blood lipid profile after eccentric lunge walking intervention.
Timepoint [2] 341569 0
Blood lipid profile will be assessed at baseline (before starting the 8-week intervention) and again 4–5 days after completing the 8-week intervention (at week 9). Note: Please check the private note section.
Primary outcome [3] 341673 0
Change in health markers , body fat, and body mass after eccentric lunge walking intervention. The changes in body fat and body mass will be assessed together as a composite primary outcome. These measures will be combined under a single primary outcome to evaluate overall changes in body composition resulting from the intervention.
Timepoint [3] 341673 0
Baseline (before starting the 8-week intervention) and immediately after completing the 8-week intervention (at week 9).
Secondary outcome [1] 447952 0
Change in mental health status after eccentric lunge walking intervention.
Timepoint [1] 447952 0
Baseline (before starting the 8-week intervention) and immediately after completing the 8-week intervention (at week 9).
Secondary outcome [2] 447953 0
Change in cognitive function after eccentric lunge walking intervention.
Timepoint [2] 447953 0
Baseline (before starting the 8-week intervention) and immediately after completing the 8-week intervention (at week 9).
Secondary outcome [3] 447954 0
Change in quality of life after eccentric lunge walking intervention.
Timepoint [3] 447954 0
Baseline (before starting the 8-week intervention) and immediately after completing the 8-week intervention (at week 9).
Secondary outcome [4] 448547 0
Change in insulin sensitivity after the eccentric lunge walking intervention (This is an additional primary outcome)
Timepoint [4] 448547 0
Insulin sensitivity will be assessed at baseline (prior to the 8-week intervention) and again 4–5 days after the intervention concludes (week 9)

Eligibility
Key inclusion criteria
Average daily step count under 4000 steps.
Do not use walking aids.
Able to walk independently without assistance.
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Presence of musculoskeletal conditions such as osteoarthritis, rheumatoid arthritis, or back pain.
History or presence of heart diseases (e.g., coronary artery disease, heart failure, arrhythmias).
Average daily step count above 4000 steps.

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 Concealment : sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin tossing
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/07/2025
Actual
Date of last participant enrolment
Anticipated
21/07/2026
Actual
Date of last data collection
Anticipated
21/07/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 319035 0
University
Name [1] 319035 0
Edith Cowan University
Country [1] 319035 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
Country
Australia
Secondary sponsor category [1] 321500 0
None
Name [1] 321500 0
Address [1] 321500 0
Country [1] 321500 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317643 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 317643 0
Ethics committee country [1] 317643 0
Australia
Date submitted for ethics approval [1] 317643 0
23/05/2025
Approval date [1] 317643 0
Ethics approval number [1] 317643 0
REMS No: 2025-06257-NOSAKA

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

Contacts
Principal investigator
Name 141670 0
Mrs Naduni Wijethunga
Address 141670 0
Exercise and Sports Science, School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Drive, Joondalup, WA 6027. AUSTRALIA
Country 141670 0
Australia
Phone 141670 0
+61 8 6304 5655
Fax 141670 0
Email 141670 0
[email protected]
Contact person for public queries
Name 141671 0
Naduni Wijethunga
Address 141671 0
Exercise and Sports Science, School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Drive, Joondalup, WA 6027. AUSTRALIA
Country 141671 0
Australia
Phone 141671 0
+61 8 6304 5655
Fax 141671 0
Email 141671 0
[email protected]
Contact person for scientific queries
Name 141672 0
Prof Ken Nosaka
Address 141672 0
Exercise and Sports Science School of Medical and Health Sciences Edith Cowan University 270 Joondalup Drive, Joondalup WA 6027. AUSTRALIA
Country 141672 0
Australia
Phone 141672 0
+61 8 6304 5655
Fax 141672 0
Email 141672 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The individual participant data from this study will not be shared publicly due to participant confidentiality and privacy concerns, as well as to comply with ethical approvals and data protection regulations.



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.