Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000880246
Ethics application status
Approved
Date submitted
18/05/2018
Date registered
25/05/2018
Date last updated
18/06/2020
Date data sharing statement initially provided
18/06/2020
Date results provided
18/06/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of strength and conditioning on running biomechanics and performance
Scientific title
The effect of strength and conditioning on running biomechanics and performance in recreational distance runners
Secondary ID [1] 294915 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise performance 307921 0
Condition category
Condition code
Musculoskeletal 306926 306926 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experimental group will participate in a strength training programme of 1 hour in duration, twice per week, for 10 weeks. The strength training program will consist of a range of open and closed chain resistance and plyometric exercises such as deadlifts, hamstring curls, squats, lunges, drop jumps, bounding and countermovement jumps focused on the gluteal, hamstring, quadriceps and calf muscles. The strength training program will be conducted in the AIS gym and be overseen by an experienced Australian Strength and Conditioning Level 2 Coach.

Each 1 hour session will consist of a 10 minute warm up (5 min cycling, 5 min dynamic stretching) followed by 45 minutes of strength training and a 5 minute cool down of static stretching. Participants will perform 3-5 sets of 4-8 repetitions of the strength training exercises. Plyometric exercises will be performed unloaded (i.e. bodyweight only) and strength based exercises (i.e. barbell sqaut) performed at 70% of 1 RM. Loads will be progressively increased to maintain this range of repetitions per set.

Participants allocated to the intervention group must attend strength training at the Australian Institute of Sport gymnasium in Bruce, ACT. Level 2 ACSA Strength and Conditioning coaches will record attendance for the duration to these sessions using participant checklists. All participants must also log training online via Google Forms. Participants must report the type, intensity, duration, number and frequency of endurance and strength training using these online logs.

Participants will train in groups of 5. Each group will be supervised by a Level 2 ASCA Strength and Conditioning coach who is external to the research team and will have no part in assessing intervention outcomes.
Intervention code [1] 301227 0
Treatment: Other
Comparator / control treatment
The control group will participate in additional running and general conditioning of 1 hours in duration, twice per week, for 10 weeks to match the additional training time of the experimental group. This will include additional running at the participants’ usual training pace and general conditioning such a lower body stretching and sit-ups. Both sessions per week will include additional running (10 min) and general conditioning exercises (50 min).

The running will be performed at the participants usual intensity of training pace (self-selected). The general conditioning exercises will include situps, back extensions, push ups, triceps dips, front and side planks, russian twists and stretching of the major lower limb muscle groups. Participants will be encouraged to perform these exercises at a low intensity in a slow and controlled manner. These sessions will be performed individually without supervision, however all participants will receive a manual outlining the general conditioning and stretching exercises.

Adherence to the program will be monitored via online training diaries submitted via Google forms.
Control group
Active

Outcomes
Primary outcome [1] 305924 0
2km time trial run performance. The 2km time trial will be performed on the outdoor running track at the Australian Institute of Sport. Timing gates will be used to record 400m split and final times and additionally a stopwatch will be used for final time. A wind-reader will be used to monitor wind velocity. Relative humidity and temperature will be monitored using the Australian Bureau of Meteorology.
Timepoint [1] 305924 0
10 weeks post-intervention commencement
Primary outcome [2] 305925 0
Running economy. Running economy will be determined by measuring submaximal oxygen consumption on a custom built motorised treadmill. Participants will run for 4 minutes at set running speeds between 8-18km/h while a custom designed open-circuit, indirect calorimetric system is used to monitor gas exchange and calculate oxygen consumption.
Timepoint [2] 305925 0
10 weeks post-intervention commencement
Secondary outcome [1] 347038 0
Running biomechanics and muscle activity will be measured simultaneously while participants run overground on a 110 metre indoor synthetic running track. Kinematic and kinetic data will be collected via a 24 camera motion analysis system and 8 in-ground kistler force plates. Muscle activity will be recorded using a 16 channel wireless electromyography system synchronised with the kinematic and kinetic data. The composite outcomes assessed include amplitude and timing of muscle activity, lower limb joint angles and velocities, joint moments, and joint work and power.
Timepoint [1] 347038 0
10 weeks post-intervention commencement
Secondary outcome [2] 347039 0
Achilles tendon stiffness. Achilles tendon stiffness will be measured via shear wave elastrography using an Aplio 500 ultrasound system with elastrography suite. An in built stiffness measurement toolbox will be used to measure the maximum, minimum and mean stiffness (Youngs modulus) of the Achilles tendon in kilopascals (KPa).
Timepoint [2] 347039 0
10 weeks post-intervention commencement
Secondary outcome [3] 347040 0
Body composition. A DEXA bone mineral densitometer (Lunar iDXA) will be used to measure muscle cross sectional area, total, leg and upper body lean mass, mass, centre of mass and moment of inertia about the sagittal axis for the head, upper trunk, middle trunk, lower trunk, upper arm, forearm, thigh and shank segments.
Timepoint [3] 347040 0
10 weeks post-intervention commencement
Secondary outcome [4] 347045 0
Lower limb strength. Maximal voluntary isometric peak force will be measured during ankle plantarflexion and dorsiflexion, knee extension and flexion, and hip extension, flexion, adduction and abduction. A custom designed dynamometer system and associated in-house software (Australian Institute of Sport, Belconnen, Australia) will be used to record maximal isometric peak force. The setup and equipment include a calibrated load cell secured to the floor (XTRAN S1W-9KN, Australia), an electronic examination table, a seatbelt, a portable 45 degree wedge and an electronic display (Omni InstrumentsAMLTR-150+RS232, product number TR150, United Kingdom).
Timepoint [4] 347045 0
10 weeks post-intervention commencement

Eligibility
Key inclusion criteria
To be included, runners need to be aged 18 to 45 years old. All participants must be distance runners, running more than >30km per week for at least 1 year prior to the study.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants must be healthy, free of any musculoskeletal injuries or disorders, and have no medical problems that could affect their ability to participate in the research or affect their running technique. Pregnant women are also excluded from the study.

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 will be performed with sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised using a computerised sequence generation. At time of randomisation participants will be matched based on gender, age and training volume.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
To determine the required sample sizes, a priori power analyses were conducted based on a significance level of 5%, power of 0.80 and an effect size of 1.0. Our power analysis revealed that the intervention component requires 11 subjects for each group (total sample size of 22). Allowing for participant drop out, we aim to recruit a total of 30 participants.

Means and standard deviations of outcome measures will be calculated. Data will be analysed using a two-way (group x time) repeated measures ANOVA. The standardised mean difference will be calculated to determine the magnitude of differences between groups at the primary endpoint.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/06/2018
Actual
6/03/2018
Date of last participant enrolment
Anticipated
10/12/2018
Actual
6/07/2018
Date of last data collection
Anticipated
4/03/2019
Actual
28/09/2018
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 299497 0
University
Name [1] 299497 0
Deakin University
Country [1] 299497 0
Australia
Primary sponsor type
Individual
Name
Dr Jason Bonacci
Address
Deakin University
75 Pigdons Road
Waurn Ponds VIC 3216
Country
Australia
Secondary sponsor category [1] 298799 0
Government body
Name [1] 298799 0
Australian Institute of Sport
Address [1] 298799 0
Leverrier Crescent
Bruce ACT 2617
Country [1] 298799 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300400 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 300400 0
Ethics committee country [1] 300400 0
Australia
Date submitted for ethics approval [1] 300400 0
Approval date [1] 300400 0
11/08/2017
Ethics approval number [1] 300400 0
2017-208
Ethics committee name [2] 300412 0
Australian Institute of Sport Ethics Committee
Ethics committee address [2] 300412 0
Ethics committee country [2] 300412 0
Australia
Date submitted for ethics approval [2] 300412 0
Approval date [2] 300412 0
16/08/2017
Ethics approval number [2] 300412 0
20170804

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

Contacts
Principal investigator
Name 83538 0
Dr Jason Bonacci
Address 83538 0
School of Exercise and Nutrition Sciences
Deakin University
75 Pigdons Road
Waurn Ponds
VIC 3216
Country 83538 0
Australia
Phone 83538 0
+61 3 5227 2634
Fax 83538 0
Email 83538 0
[email protected]
Contact person for public queries
Name 83539 0
Jason Bonacci
Address 83539 0
School of Exercise and Nutrition Sciences
Deakin University
75 Pigdons Road
Waurn Ponds
VIC 3216
Country 83539 0
Australia
Phone 83539 0
+61 3 5227 2634
Fax 83539 0
Email 83539 0
[email protected]
Contact person for scientific queries
Name 83540 0
Jason Bonacci
Address 83540 0
School of Exercise and Nutrition Sciences
Deakin University
75 Pigdons Road
Waurn Ponds
VIC 3216
Country 83540 0
Australia
Phone 83540 0
+61 3 5227 2634
Fax 83540 0
Email 83540 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
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.