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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]

‘Nil known’

Universal Trial Number (UTN)

U1111-1313-6924

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Osteoporosis

Condition category

Condition code

Musculoskeletal

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]

Prevention

Intervention code [2]

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]

Bone Mineral Density at the Femoral Neck

Timepoint [1]

Baseline and 6 months post intervention commencement

Primary outcome [2]

Bone Mineral Density at the Total Hip

Timepoint [2]

Baseline and 6 months post intervention commencement

Primary outcome [3]

Bone Mineral Density at the Lumbar Spine

Timepoint [3]

Baseline and 6 months post intervention commencement

Secondary outcome [1]

Quality of Life

Timepoint [1]

Baseline and 6 months post intervention commencement

Secondary outcome [2]

Bone-relevant biomarker

Timepoint [2]

Baseline and 6 months post intervention commencement

Secondary outcome [3]

Strength- lower limb strength

Timepoint [3]

Baseline and 6 months post intervention commencement

Secondary outcome [4]

Balance

Timepoint [4]

Baseline and 6 months post intervention commencement

Secondary outcome [5]

Body composition

Timepoint [5]

Baseline and 6 months post intervention commencement

Secondary outcome [6]

Feasibility: Domain Process - Recruitment rates

Timepoint [6]

At the completion of the enrolment period

Secondary outcome [7]

Feasibility: Domain Process - Reach eligible women

Timepoint [7]

At the completion of the enrolment period

Secondary outcome [8]

Feasibility: Domain Process - Drop out rates

Timepoint [8]

At the completion of the intervention

Secondary outcome [9]

Feasibility: Domain Resources - Mean time

Timepoint [9]

At the completion of the intervention

Secondary outcome [10]

Feasibility: Domain Scientific - Adherence

Timepoint [10]

At the completion of the intervention

Secondary outcome [11]

Feasibility: Domain Scientific - Adverse events

Timepoint [11]

At the completion of the intervention

Secondary outcome [12]

Minor discomfort - Soreness

Timepoint [12]

6 months post intervention commencement

Secondary outcome [13]

Acceptability

Timepoint [13]

6 months post intervention commencement

Secondary outcome [14]

Preferences

Timepoint [14]

6 months post intervention commencement

Secondary outcome [15]

Wellbeing

Timepoint [15]

Baseline and 6 months post intervention commencement

Secondary outcome [16]

Strength - Functional strength

Timepoint [16]

Baseline and 6 months post intervention commencement

Secondary outcome [17]

Strength - leg strength

Timepoint [17]

Baseline and 6 months post intervention commencement

Secondary outcome [18]

Strength - handgrip strength

Timepoint [18]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

5000 - Adelaide

Recruitment postcode(s) [2]

5005 - Adelaide University

Funding & Sponsors

Funding source category [1]

University

Name [1]

HDR Funds University of Adelaide Research Scholarship

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

University of Adelaide

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Adelaide Human Research Ethics Committee

Ethics committee address [1]

https://www.adelaide.edu.au/research-services/ethics-compliance-integrity/human-research-ethics/human-research-ethics-committee

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/05/2024

Approval date [1]

05/09/2024

Ethics approval number [1]

H-2024-149

Summary

Brief summary

Bone loss is a common health problem in older people, particularly women, and can significantly affect their quality of life. Progressive resistance training has been shown to be effective in preventing bone loss. However, several questions remain regarding the optimal design of such interventions. One such aspect is movement velocity. The aim of this project is to investigate whether faster movement velocities are more effective in improving bone mineral density.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Timothy John Hedley Lathlean

Address

The University of Adelaide, North Terrace Campus, Adelaide SA 5005, Australia

Country

Australia

Phone

+61 8 8313 1006

Fax

[email protected]

Contact person for public queries

Name

Riccarda Albana Quattlaender

Address

The University of Adelaide, North Terrace Campus, Adelaide SA 5005, Australia

Country

Australia

Phone

+61 8 8313 1006

Fax

[email protected]

Contact person for scientific queries

Name

Riccarda Albana Quattlaender

Address

The University of Adelaide, North Terrace Campus, Adelaide SA 5005, Australia

Country

Australia

Phone

+61 8 8313 1006

Fax

[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.	Type	Citation	Link	Email	Other Details	Attachment
24216	Ethical 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.

Trial Review

Documents added manually

Documents added automatically