Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624001276549
Ethics application status
Approved
Date submitted
25/09/2024
Date registered
18/10/2024
Date last updated
18/10/2024
Date data sharing statement initially provided
18/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
OsteoVelocity - Effects of different Velocities in Resistance Training on Bone Mineral Density in Women: A Randomized Controlled Trial
Scientific title
OsteoVelocity - Effects of different Velocities in Progressive Resistance Training on Bone Mineral Density in Healthy Women over 45: A Pilot of a Randomized Controlled Trial
Secondary ID [1] 313051 0
‘Nil known’
Universal Trial Number (UTN)
U1111-1313-6924
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 335272 0
Condition category
Condition code
Musculoskeletal 331846 331846 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention groups 'high strain training' (HST) and 'low strain training' (LST) will participate in two supervised resistance training sessions per week for a duration of 6 months. Each session will last approximately 1 hour and 15 minutes. Training will be conducted in small groups with a maximum of 7 participants per group. A researcher will explain the exercises and all relevant parameters (e.g., movement velocity, range of motion, rest period, etc.) to the participants. Furthermore, a researcher will observe and provide corrective feedback to the participants during their performance. The feedback will encompass aspects such as posture, breathing, range of motion, tempo, and muscle engagement. Every mesocycle will begin with a two-week period of low-intensity exercise for learning purposes, followed by a five-week phase of moderate intensity and another five weeks of high-intensity training. The Borg Rating of Percieved Exertion Scale (RPE) and repetition ranges will be used to guide exercise intensity. Moderate intensity, approximately 65-75% of one repetition maximum (1 RM), will involve 10 to 15 repetitions, while high intensity, about 80-90% of 1 RM, will consist of 8 to 5 repetitions. The achieved weight and RPE will be recorded in the training log book for each exercise and set. Subsequently, the exercises will be modified. While the initial half of the intervention primarily incorporates less complex exercises on machines (e.g., leg press), the latter half will introduce more intricate movements (e.g., squats). Prior to each progressive resistance training session, there will be a general warm-up and a brief specific warm-up with drills to acclimate participants to the anticipated movement velocity. The intervention groups differ solely in the targeted movement velocity. The HST group will execute all exercises with an explosive concentric phase, a brief isometric hold at the turning point, and an eccentric phase at moderate velocity (X/1/2). The LST group will perform all exercises with an explosive concentric phase, a brief isometric hold at the turning point, and an extended eccentric phase (X/1/4). Both active groups will be instructed to execute the concentric phase at maximal velocity (X). The HST group will be directed to perform the eccentric phase at moderate velocity (2s), while the LST group will be instructed to execute a slow eccentric phase (4s). Session attendance will be recorded in the training logbook.
Intervention code [1] 329603 0
Prevention
Intervention code [2] 329675 0
Lifestyle
Comparator / control treatment
The control group (CG) will be advised to maintain their usual daily activities and refrain from initiating new physical activities. Additionally, participants are queried about their exercise habits in an exit survey designed for this study. The survey incorporates questions derived from the BPAQ - a tool designed to predict BMD based on physical activity history. These inquiries will facilitate proper analysis of the results. In the event that control participants initiate physical activity, this information will be documented. Furthermore, by utilizing questions from a validated tool, additional insight will be gained regarding potential influences on the results.
Control group
Active

Outcomes
Primary outcome [1] 339466 0
Bone Mineral Density at the Femoral Neck
Timepoint [1] 339466 0
Baseline and 6 months post intervention commencement
Primary outcome [2] 339467 0
Bone Mineral Density at the Total Hip
Timepoint [2] 339467 0
Baseline and 6 months post intervention commencement
Primary outcome [3] 339468 0
Bone Mineral Density at the Lumbar Spine
Timepoint [3] 339468 0
Baseline and 6 months post intervention commencement
Secondary outcome [1] 440088 0
Quality of Life
Timepoint [1] 440088 0
Baseline and 6 months post intervention commencement
Secondary outcome [2] 440089 0
Bone-relevant biomarker
Timepoint [2] 440089 0
Baseline and 6 months post intervention commencement
Secondary outcome [3] 440090 0
Strength- lower limb strength
Timepoint [3] 440090 0
Baseline and 6 months post intervention commencement
Secondary outcome [4] 440091 0
Balance
Timepoint [4] 440091 0
Baseline and 6 months post intervention commencement
Secondary outcome [5] 440092 0
Body composition
Timepoint [5] 440092 0
Baseline and 6 months post intervention commencement
Secondary outcome [6] 440093 0
Feasibility: Domain Process - Recruitment rates
Timepoint [6] 440093 0
At the completion of the enrolment period
Secondary outcome [7] 440094 0
Feasibility: Domain Process - Reach eligible women
Timepoint [7] 440094 0
At the completion of the enrolment period
Secondary outcome [8] 440095 0
Feasibility: Domain Process - Drop out rates
Timepoint [8] 440095 0
At the completion of the intervention
Secondary outcome [9] 440096 0
Feasibility: Domain Resources - Mean time
Timepoint [9] 440096 0
At the completion of the intervention
Secondary outcome [10] 440099 0
Feasibility: Domain Scientific - Adherence
Timepoint [10] 440099 0
At the completion of the intervention
Secondary outcome [11] 440100 0
Feasibility: Domain Scientific - Adverse events
Timepoint [11] 440100 0
At the completion of the intervention
Secondary outcome [12] 440101 0
Minor discomfort - Soreness
Timepoint [12] 440101 0
6 months post intervention commencement
Secondary outcome [13] 440102 0
Acceptability
Timepoint [13] 440102 0
6 months post intervention commencement
Secondary outcome [14] 440397 0
Preferences
Timepoint [14] 440397 0
6 months post intervention commencement
Secondary outcome [15] 440756 0
Wellbeing
Timepoint [15] 440756 0
Baseline and 6 months post intervention commencement
Secondary outcome [16] 440759 0
Strength - Functional strength
Timepoint [16] 440759 0
Baseline and 6 months post intervention commencement
Secondary outcome [17] 440761 0
Strength - leg strength
Timepoint [17] 440761 0
Baseline and 6 months post intervention commencement
Secondary outcome [18] 440762 0
Strength - handgrip strength
Timepoint [18] 440762 0
Baseline and 6 months post intervention commencement

Eligibility
Key inclusion criteria
Healthy untrained women over 45
Minimum age
45 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Not fluent in English
• Current smokers
• Pregnancy
• Breastfeeding
• Trained (Participated in resistance training or a structured weight-bearing exercise program at least once a week in the past 12 months)
• Inability to participate in a supervised exercise program if assigned.
• Contraindications to participating in vigorous physical activity
• Cardiovascular disease
• Cognitive impairment
• Recent radiotherapy
• Joint injury or surgery
• Fracture (within the past 12 months)
• Depression
• Medications known to affect bone
• Medical conditions known to affect bone health
• Osteoporosis (T-Score under -2,5)
• Obesity (BMI > 30)
• High alcohol consumption (more than 14 standard drinks per week)

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)
Randomization will be conducted by a researcher not involved in recruitment or measurement.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be block randomized based on their BMD (total hip) to either the HST, LST or CG. The participant code and BMD (total hip) value will be listed and sorted according to BMD (total hip).

Participants will be divided into blocks; participants within each block will be allocated to different treatment groups according to the block randomization scheme generated by www.randomizer.org.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2024
Actual
Date of last participant enrolment
Anticipated
13/06/2025
Actual
Date of last data collection
Anticipated
23/12/2025
Actual
Sample size
Target
51
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 43225 0
5000 - Adelaide
Recruitment postcode(s) [2] 43226 0
5005 - Adelaide University

Funding & Sponsors
Funding source category [1] 317491 0
University
Name [1] 317491 0
HDR Funds University of Adelaide Research Scholarship
Country [1] 317491 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 319784 0
None
Name [1] 319784 0
Address [1] 319784 0
Country [1] 319784 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316204 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 316204 0
Ethics committee country [1] 316204 0
Australia
Date submitted for ethics approval [1] 316204 0
24/05/2024
Approval date [1] 316204 0
05/09/2024
Ethics approval number [1] 316204 0
H-2024-149

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

Contacts
Principal investigator
Name 137134 0
Dr Timothy John Hedley Lathlean
Address 137134 0
The University of Adelaide, North Terrace Campus, Adelaide SA 5005, Australia
Country 137134 0
Australia
Phone 137134 0
+61 8 8313 1006
Fax 137134 0
Email 137134 0
[email protected]
Contact person for public queries
Name 137135 0
Riccarda Albana Quattlaender
Address 137135 0
The University of Adelaide, North Terrace Campus, Adelaide SA 5005, Australia
Country 137135 0
Australia
Phone 137135 0
+61 8 8313 1006
Fax 137135 0
Email 137135 0
[email protected]
Contact person for scientific queries
Name 137136 0
Riccarda Albana Quattlaender
Address 137136 0
The University of Adelaide, North Terrace Campus, Adelaide SA 5005, Australia
Country 137136 0
Australia
Phone 137136 0
+61 8 8313 1006
Fax 137136 0
Email 137136 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data will be uploaded to the Figshare online repository, as recommended by
the University of Adelaide.
When will data be available (start and end dates)?
Beginning 3 months after publication and ending 15 years following main results publication.
Available to whom?
Researchers from the University of Adelaide or other institutions who submit a methodologically sound proposal are eligible. The decision will be made by Dr. Timothy Lathlean and Riccarda Quattlaender.
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
Data can be obtained via email ([email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24216Ethical approval    388519-(Uploaded-25-09-2024-15-23-44)-Approval H-2024-149 39249 Lathlean_Quattlaender (24.09.05) (1).pdf



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.