Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000761460p
Ethics application status
Submitted, not yet approved
Date submitted
9/04/2025
Date registered
17/07/2025
Date last updated
17/07/2025
Date data sharing statement initially provided
17/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the benefits of Uphill Running versus Jumping Exercise on Runner's Physical Fitness, Performance and Injury risk
Scientific title
Comparative Effects of Uphill Running versus Plyometric Training on Physical Function, Performance Metrics and Risk of Lower Limb Injury Among Recreational Runners
Secondary ID [1] 314158 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower Limb Injury 336991 0
Condition category
Condition code
Physical Medicine / Rehabilitation 333452 333452 0 0
Physiotherapy
Musculoskeletal 333453 333453 0 0
Other muscular and skeletal disorders
Injuries and Accidents 333454 333454 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A two-arm parallel design, single-blinded (assessor) randomized experimental trial, where 28 study participants are randomly assigned into uphill running and plyometric training group to compare the effects of two different active intervention on specific outcome measures without a control group. This study will be conducted according to the CONSORT protocol at Padang Merbok, Kuala Lumpur. The stipulated area is open to public and easily accessible due to nearby parks and it is a well known running location for runners. Uphill running group (n=14) will perform uphill sprints ranging from 20m-50m, a 10m mark signage will be placed at the curb-side to inform participants the distances they need to cover, e.g. 30m uphill sprint will have 3 signage on every 10m mark distance. All participants will be completing the sprint in groups, and they will be asked to remember the number of sprints they did, the number of sprints completed by the participants will be double checked and verified again by an assistance researcher (who is not involved in intervention, randomization, outcome assessment & recruitment of participants) with a hand-held tally counter and the number of sets completed will be marked on a piece of blank paper, at the bottom of the hill where participants will stand again at the starting line to repeat the uphill sprints. A score board for numbers of completed repetition will be placed at the bottom of the hill to inform participants how many repetitions left to go. Below are the examples of uphill sprints in the context of repetitions and sets that will progress until week-8 adapted from Hindistan et al. 2020. Week 1-2: 20m uphill sprint x 3 reps x 4 sets; week 3-4: 30m uphill sprint x 4 reps x 4 sets; week 5-6: 30m uphill sprint x 5 reps x 1st set/40m uphill sprint x 4 reps x 2nd set/30m uphill sprint x 5 reps x 3rd set/40m uphill sprint x 4 reps x 4th set; week 7-8: 40m uphill sprint x 5 reps x 1st set/50m uphill sprint x 5 reps x 2nd set/40m uphill sprint x 5 reps x 3rd set/50m uphill sprint x 5 reps x 4th set. Duration of each training are expected to be approximately 1 hour. While plyometric training group (n=14) will perform plyometric exercises such as double and single leg 30cm hurdle hops, alternate leg bounds and split jumps for the duration of 8-weeks, twice per week. A certified physiotherapist, who has 5 years working experience is trained to rigorously follow the intervention protocol will be responsible for administrating the assigned interventions (uphill running or plyometric training) and supervising participants throughout the 8-weeks intervention period. The physiotherapist will not be involved in the recruitment, randomization or outcome assessment processes. Outcomes will be assessed using validated tools, including VAS for self-reported muscle soreness, hip adductor strength (measured using force gauge), Y-balance test for physical function, 5km time trial, and single-leg hop test for performance metrics. Lower limb injury risk will be interpreted based on findings from limb asymmetry in terms of strength and dynamic balance.
Intervention code [1] 330751 0
Prevention
Intervention code [2] 330752 0
Treatment: Other
Comparator / control treatment
Plyometric Training group (n=14) will be the active control group, this group will perform plyometric exercises such as double and single leg 30cm hurdle hops, alternate leg bounds and split jumps for the duration of 8-weeks, twice per week also at Padang Merbok, Kuala Lumpur. The participants will be completing the plyometric exercise 2 person at a time, arranging 2 rows of 10 x 30cm hurdle hops. Participants need to finish each exercise repetitions and sets before moving on with the next exercise, order of the plyometric exercise will be hurdle hop first, followed by alternate leg bounding and then split jump. A certified physiotherapist, who has 5 years working experience is trained to rigorously follow the intervention protocol will be responsible for administrating the assigned plyometric exercise and supervising participants throughout the 8-weeks intervention period. The physiotherapist will not be involved in the recruitment, randomization or outcome assessment processes. The participants will be instructed to remember the number of repetitions they completed for plyometric exercise, and it will be double checked and verified by an assistance researcher, who will be keeping tabs on the numbers of repetition completed by participants with a hand-held tally counter and the number of sets completed will be marked on a piece of blank paper. A score board for numbers of completed sets for plyometric training group will be used to inform participants how many sets left to go. Duration of each session for plyometric training are expected to be approximately 1 hour. Below are the examples of plyometric exercise in terms of repetitions and sets and that will progress until week-8 adapted from Lum et al.2023 & Lum et al. 2019. Week 1-2: Double leg 30 cm hurdle hop x 10 reps x 3 sets/Alternate leg bounding x 30 reps x 3 sets/Split jump x 5 reps x 3 sets each side; week 3-4: Double leg 30 cm hurdle hop x 10 reps x 3 sets/Alternate leg bounding x 30 reps x 4 sets/Split jump x 5 reps x 4 sets each side; week 5-6: Double leg 30 cm hurdle hop x 10 reps x 4 sets/Single leg 30 cm hurdle hop x 5 reps x 3 sets each side/Alternate leg bounding x 40 reps x 4 sets/Split jump x 5 reps x 4 sets each side; week 7-8: Double leg 30 cm hurdle hop x 10 reps x 4 sets/Single leg 30 cm hurdle hop x 5 reps x 4 sets each side/Alternate leg bounding x 40 reps x 4 sets/Split jump x 5 reps x 2 sets.
Control group
Active

Outcomes
Primary outcome [1] 341029 0
5km time trial (Performance Metrics)
Timepoint [1] 341029 0
5km time trial will be assessed at baseline and post-intervention (5 days after last intervention session)
Secondary outcome [1] 445869 0
Single Leg Hop Test (Performance Metrics)
Timepoint [1] 445869 0
Baseline and post-intervention (2 days after last intervention session)
Secondary outcome [2] 445870 0
Isometric Hip Adductor Strength (Physical Function)
Timepoint [2] 445870 0
Baseline and post-intervention (2 days after last intervention session)
Secondary outcome [3] 445871 0
Y-Balance Test (Physical Function)
Timepoint [3] 445871 0
Baseline and post-intervention (2 days after last intervention session)
Secondary outcome [4] 445872 0
Visual Analog Scale (VAS)
Timepoint [4] 445872 0
baseline, week 4, post-intervention (2 days after last intervention session)

Eligibility
Key inclusion criteria
Healthy adult aged 18-55 years old, able to read and speak in English or Bahasa, have minimum one year of running experience, included participants are required to engage in running at least three times per week, covering a minimum mileage of 25km-60km per week.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are having acute musculoskeletal injuries for the past 6 months or having surgical history at lower back or lower extremities for the past 1 year, having any uncontrollable chronic illness that would hinder participation in the intervention or physical metrics measurements (e.g. heart disease, stroke, cancer, hypertension, diabetes, obesity, COPD, asthma and arthritis). Participants will be excluded if they are currently engaged in any structured training programs, including resistance or bodyweight training performed once per week or more, systematic running regime, with specific mileage and intensity goals adapted from running applications, websites or under the guidance of a running coach.

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)
The principal investigator (PI) who is not involved in participant recruitment, intervention administration or outcome assessment will manage stratified block randomization by gender with staggered implementation. Recruited participants will first be allocated into seven blocks of four participants each, with an equal distribution of males and females within each block. Subsequently, a computer-generated randomization sequence will be used to assign participants within each block into either uphill running or plyometric training group using an online randomization tool (Research Randomizer, https://randomizer.org/). Staggered implementation ensures that the assigned intervention protocol for each block begins as soon as the block is filled, and all blocks will follow the same 8-weeks intervention duration. The principal investigator (PI) will prepare the randomization sequence, oversee the randomization process and ensure proper implementation of the allocation concealment mechanism using sealed, opaque, and sequentially numbered envelopes. Participants will only learn about their assigned group after opening the envelope, ensuring that allocation remains concealed until the moment of assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified block randomization by gender with staggered implementation. Computer generated randomization sequence will be used to assign participants within each block to either uphill running or plyometric training group using an online randomization tool (Research Randomizer, https://randomizer.org/)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation in this study was based on existing literature by Machado et al. (2019), that uses 5km time trial as the primary outcome measure. The calculation was based on Cohen’s medium effect size of 0.5, power (1-ß) of 0.8, and a significance level (a) of 0.05 (95% confidence level). The total sample size calculated using these parameters accounts to 26 participants. However, to enhance the reliability and robustness of the study with an inclusion of 10% dropout rate, the adjusted sample size was increased to 28 participants to maintain adequate statistical power. Data analysis for this study will be conducted using SPSS version 29, will adhere to intention-to-treat (ITT) protocol as the primary analysis and per protocol (PP) as the secondary analysis as recommended by CONSORT guideline. Descriptive statistics will be used describe the baseline sociodemographic characteristic of participants (age, gender, occupation, highest education, BMI, running experience, weekly mileage, weekly running frequency). The primary statistical analysis for assessing outcomes will involve mixed design ANOVA (Analysis of Covariance) upon meeting the assumptions of normality, sphericity, homoscedasticity and outliers. Mixed design ANOVA will be used to examine within-subjects factors (repeated measures over time within the same group), and also for between-subjects factors (comparing outcomes between uphill running and plyometric exercise groups to assess intervention effect) in terms of Visual Analog Scale (VAS) for self-reported muscle soreness, hip adductor strength (measured using force gauge), Y-balance test for physical function, 5km time trial and single-leg hop test for performance metrics. All statistical significance will be set at p <0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
31/10/2026
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment outside Australia
Country [1] 26955 0
Malaysia
State/province [1] 26955 0
Wilayah Persekutuan Kuala Lumpur

Funding & Sponsors
Funding source category [1] 318669 0
Self funded/Unfunded
Name [1] 318669 0
Country [1] 318669 0
Primary sponsor type
Individual
Name
Tham Sze Kei (Universiti Kebangsaan Malaysia)
Address
Country
Malaysia
Secondary sponsor category [1] 321118 0
None
Name [1] 321118 0
None
Address [1] 321118 0
Country [1] 321118 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317283 0
Research Ethics Committee Universiti Kebangsaan Malaysia
Ethics committee address [1] 317283 0
Ethics committee country [1] 317283 0
Malaysia
Date submitted for ethics approval [1] 317283 0
02/04/2025
Approval date [1] 317283 0
Ethics approval number [1] 317283 0

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

Contacts
Principal investigator
Name 140558 0
Dr Mohd Azzuan Bin Ahmad
Address 140558 0
Center for Rehabilitation and Special Needs Studies (ICaRehab), Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur Campus, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur
Country 140558 0
Malaysia
Phone 140558 0
+60392897263
Fax 140558 0
Email 140558 0
[email protected]
Contact person for public queries
Name 140559 0
Tham Sze Kei
Address 140559 0
Center for Rehabilitation and Special Needs Studies (ICaRehab), Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur Campus, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur
Country 140559 0
Malaysia
Phone 140559 0
+60392897263
Fax 140559 0
Email 140559 0
[email protected]
Contact person for scientific queries
Name 140560 0
Tham Sze Kei
Address 140560 0
Center for Rehabilitation and Special Needs Studies (ICaRehab), Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur Campus, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur
Country 140560 0
Malaysia
Phone 140560 0
+60392897263
Fax 140560 0
Email 140560 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:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]; [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: response time may take a while



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.