Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001145392p
Ethics application status
Not yet submitted
Date submitted
28/07/2017
Date registered
7/08/2017
Date last updated
7/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The chronic effects of a quantified jump-landing programme on bone health in premenopausal women.
Scientific title
The chronic effects of a quantified jump-landing programme on bone health in premenopausal women.
Secondary ID [1] 292546 0
None
Universal Trial Number (UTN)
U1111-1199-8337
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 304201 0
Condition category
Condition code
Musculoskeletal 303538 303538 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will use a controlled trial experimental design implemented to determine the effects of a 12 month jump-landing programme (The formulation and design of the jump-landing programme utilised data gained from Study 1 in thesis) (Clissold et al. under review), intervention on parameters of bone health for premenopausal women. The jump-landing programme utilises the training principles and progression described for best practice in strength and conditioning. Data will be collected using dual energy X-ray absorptiometry (DEXA) utilising specialised hip structural analysis (HSA) software. Data will be compared using repeated measures ANOVA and effect statistics.
Participants in the treatment group will be required to perform the regular (2-5 times/ week, with frequency increased progressively to allow for anatomical adaptation), jump-landing programme (in their own homes), and attend jump-landing group classes regularly (ideally weekly). The jump-landing exercise programme is expected to involve around 20 minutes to complete including a brief warm up and cool down, and can be performed at a time and place that suits the schedule of each participant.
Participants will come into the laboratory on five occasions for data collection, which will involve around 1-2 hours for the familiarisation session and 1 hour for testing at 3, 6, 9 and 12 months.
The following factors have been identified and discussed:
The actual jump testing, and the jump-landing programme will carry minimal risk, as exercises selected are achieving the minimal threshold identified as producing osteogenic benefit to bone. All testing and jump training (supervised or unsupervised), will be preceded by warm up and mobilisation exercises, and these same exercises will be used to warm down the participant (to minimise any chance of post exercise muscle soreness). Participants will be excluded if: any medical problems are reported that compromise their participation or performance in this study: including having a recent or current musculoskeletal injury, osteoarthritis and any condition of impaired balance or coordination. Participants will also be excluded if they are pregnant. In addition, the exercise regime during the intervention period will be monitored via phone calls, text messages and emails, with participants encouraged to contact the researcher any time about any concerns or issues they might have.
The training programme will include combinations made from the following jumps; 1) countermovement jump with reactive jump, 2) drop jump with reactive jump, 3) star jump with reactive jump, 4) stride jump with reactive jump, 5) countermovement vertical hop, 6) countermovement lateral hop, and 7) countermovement forward hop. It is proposed that this programme will increase in magnitude and rate of strain, number of ground contacts and technical difficulty (i.e. bilateral to unilateral) in a progressive manner over the 12 month period. The jumping programme will take no more than 20 minutes including a brief warm-up and cool down. Participants will be required to attend weekly group exercise sessions ( of 20 min duration) which will be run by qualified exercise trainers (jump-landing classes) and perform the same jump-landing programme in a group environment. This requirement is expected to positively affect compliance to the programme and provide a regular opportunity to monitor jumping proficiency and provide feedback to individuals when required to create a “club-like” environment (Wang et al., 2016). In addition adherence will be monitored using a register of attendance at group sessions and diary of home exercise completed, The jump-landing programme will utilise a model of periodisation to ensure that training principles are manipulated safely and effectively to achieve long-term benefit to bone health. Hence the concept of clustering the jumps will be explored to optimise the osteogenic effect over time whilst adhering to safe programming guidelines. The proposed programme will progress in volume and technical difficulty over the 12 months (in an individualised manner to reflect safety and proficiency of the participants), and its development will be based on previous studies which have safely achieved enhanced bone mineral density in premenopausal women over similar time periods. The loading of each mesocycle (4-week block of training), will utilise a 3:1 structure involving a progressive increase in jumping volume (loading) over the first 3 weeks, followed by a de-loading week characterised by low volume to enhance bone and muscular adaptations and provide opportunity for bone to re-sensitise before introducing a new jumping stimulus (Bompa & Haff, 2009; Fleck & Kraemer, 2014; Haff & Triplett, 2015).

eg. Phase 1: Initial Adaptation (weeks 1-4) will involve performing the jump-landing programme 2-3 X week (2-3 sets of 5 maximal countermovement jumps, 20-42 total jump-landings, with 30 sec rest between sets).

Phase 2: Bilateral 1 (weeks 5-8) will involve performing the jump-landing programme 3 X week (3 sets of 4-5 maximal countermovement jumps, 48-60 total jump-landings, with 30 sec rest between sets).

Phase 9: Unilateral and Bilateral 7 (weeks 49-52) will involve performing the jump-landing programme 5 X week (2-3 sets of 5-6 maximal drop jumps (20cm), vertical and lateral hops, 50-60 total jump-landings, with 30 sec rest between sets).

Please note that the participants progression between phases will be monitored by trained exercise specialists. The regular assessment of participants performing the jump-landings at the group jump-landing classes, and regular testing sessions, will allow for modification and further individualisation of the jump-training programme based on criteria set for safety and proficiency.
Intervention code [1] 298743 0
Prevention
Intervention code [2] 298781 0
Treatment: Other
Comparator / control treatment
Due to the study design, and to achieve the desired statistical power, we ideally would like to recruit 40 women in the treatment group and 40 women in the control group. The subjects will be assigned into either the training or control groups, based on geographical location and their willingness to participate in the regular (2-5 times/week) jump-landing programme (in their own homes), and attend jump-landing group classes regularly. Please note that the control group will not participate in either of the jump-landing programmes (home or group classes), and will be asked to continue with their normal activity levels. It is likely that due to resource constraints the treatment group will be recruited in the Bay of Plenty region (location of the Coordinating Investigator), and the control group in the Auckland region. The control group will not be informed about the group participating in the jumping programme, as it is important to enable comparison with an age-matched control group who is predicted to experience bone losses as is normal for women of this age not participating in regular high impact activities. Thus the control group will not be performing the jump-landing programme, or any intervention, to provide an ability to compare the treatment group with a group who will represent normal age-related losses in bone mineral density.
Please note that although the control group will not be doing the jump-landing programme, the benefits to this group include; monitoring of bone mineral density, food diary analysis, and anthropometrical analysis. As this is a study that may impact evidence-based practice for health, wellness and fitness in general, care will be given to provide the opportunity for all groups (treatment and control), to have access to the information that will be gleaned from this research.
Control group
Active

Outcomes
Primary outcome [1] 302914 0
Bone Mineral Density at lumbar spine and femoral neck using DEXA.
Timepoint [1] 302914 0
Baseline, 6 months and 12 months (primary timepoint) after the start of the intervention.
Primary outcome [2] 302915 0
Body composition using DEXA
Timepoint [2] 302915 0
Baseline, 6 months and 12 months (primary timepoint) after the start of the intervention
Primary outcome [3] 302916 0
Jump height using a Vertec device.
Timepoint [3] 302916 0
Baseline, 6 months and 12 months (primary timepoint) after the start of the intervention.
Secondary outcome [1] 337424 0
Balance using the Accusway Force plate.
Timepoint [1] 337424 0
Baseline, 3, 6, 9 and 12 months.
Secondary outcome [2] 337425 0
Daily calcium intake using Foodworks nutritional analysis.
Timepoint [2] 337425 0
Baseline, 3, 6, 9 and 12 months
Secondary outcome [3] 337426 0
Daily activity levels using training diaries.
Timepoint [3] 337426 0
Baseline, 3, 6, 9 and 12 months
Secondary outcome [4] 337427 0
Anthropometry (height and weight), using a stadiometer and Bioelectrical Impedance Analysis (BIA).
Timepoint [4] 337427 0
Baseline, 3, 6, 9 and 12 months.

Eligibility
Key inclusion criteria
All participants will be considered healthy as determined by a Physical Activity Readiness Questionnaire (PAR-Q) and inclusion criteria will require participants to be between 30 and 50 years of age, in conjunction with participants reporting a regular menstrual cycle (9–12 menstrual cycles in the previous 12 months) to determine premenopausal status (Lawton et al., 2008; Winters-Stone et al., 2013; Winters-Stone & Snow, 2006). Participants will be excluded if they are pregnant.
The study participants will be recruited within the local area for the following reasons; a) to enable participation in weekly group jumping classes, b) to be available for regular testing sessions, and c) to improve compliance over the course of the 12 month study.
Minimum age
30 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if: any medical problems are reported that compromise their participation or performance in this study: including having a recent or current musculoskeletal injury, osteoarthritis and any condition of impaired balance or coordination. Participants will be excluded if they are pregnant. Participants will be also be excluded if currently (or in the past 12 months), engaged in regular physical activity involving impact exercise and if taking corticosteroids. Participants will be asked whether they are taking any form of hormonal contraceptive, however will not be excluded for this reason, as within-group analysis will be performed to determine the influence of this factor.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Due to the study design, and to achieve the desired statistical power, we ideally would like to recruit 40 women in the treatment group and 40 women in the control group. The subjects will be assigned into either the training or control groups, based on geographical location and their willingness to participate in the regular (2-5 times/week), jump-landing programme (in their own homes), and attend jump-landing group classes regularly. Please note that the control group will not be performing the jump-landing programme, and will be asked to maintain their normal activity levels. It is likely that due to resource constraints the treatment group will be recruited in the Bay of Plenty region (where the Co-ordinating researcher is based), and the control group in the Auckland region. Such a design was thought necessary to improve the adherence to the jump-landing training programme. Subjects will be required to attend weekly group exercise sessions (jump-landing classes) and perform the same jump-landing programme in a group environment.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The descriptive statistics will be calculated and reported as mean and standard deviations. Repeated measures ANCOVA will be performed to determine the differences in BMD between the treatment and control groups for clinically relevant sites. Covariates to be examined include calcium, vitamin D and protein. Follow-up post hoc analyses on significant ANCOVAs will be performed using Bonferroni post hoc method to determine which group contrasts were significantly different. Significance will be accepted at the p = 0.05 level. Effect sizes (ES = mean change/standard deviation of the sample scores) using ratios of 0.1 – 0.2, 0.2 – 0.3, > 0.3 indicating small, moderate and large changes, respectively, were calculated based on significant improvements (ES = 0.15 to 0.26) on BMD increases previously reported in this population. The percentage change in BMD will be calculated by dividing the difference in BMD over a time period (i.e. the baseline BMD level subtracted by the 12 week level), by the baseline level to evaluate the time course of the bones response to the jump programme at 12, 26 and 52 weeks. Subjects who do not complete at least 80% of their prescribed activity will be eliminated from the study for noncompliance. All statistical analyses will be carried out using SPSS 23.0 for Windows (SPSS Inc., Chicago, IL, USA).
Associate Professor Scott Duncan (AUT Head of Research and Statistics) has run the priori analysis for the number of subjects needed and has been involved in the formatting of the study design and will be utilised during data analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/10/2017
Actual
Date of last participant enrolment
Anticipated
30/11/2017
Actual
Date of last data collection
Anticipated
31/01/2019
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 9112 0
New Zealand
State/province [1] 9112 0
Bay of Plenty
Country [2] 9113 0
New Zealand
State/province [2] 9113 0
Auckland

Funding & Sponsors
Funding source category [1] 297118 0
University
Name [1] 297118 0
Auckland University of Technology
Country [1] 297118 0
New Zealand
Funding source category [2] 297128 0
Other
Name [2] 297128 0
Toi Ohomai Institute of Technology
Country [2] 297128 0
New Zealand
Primary sponsor type
Individual
Name
Tracey Clissold
Address
Toi Ohomai Institute of Technology
Windemere Campus
Sport and Recreation
Private Bag 12001
TAURANGA 3143
Country
New Zealand
Secondary sponsor category [1] 296131 0
University
Name [1] 296131 0
AUT University
Address [1] 296131 0
Graduate research School
Private Bag 92006
Auckland 1020
Country [1] 296131 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 298296 0
NZ Health and Disability Ethics committee
Ethics committee address [1] 298296 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 298296 0
New Zealand
Date submitted for ethics approval [1] 298296 0
01/08/2017
Approval date [1] 298296 0
Ethics approval number [1] 298296 0

Summary
Brief summary
Researchers have shown exercise regimes involving impact forces to be a powerful bone stimulus resulting in mineralisation in areas where the stress is applied, however specific protocols to optimise bone health are currently lacking. This research will use a controlled trial experimental design implemented for a period of 12 months to determine the effects of a previously quantified jump-landing programme (The formulation and design of the jump-landing programme utilised data gained from earlier research) intervention on parameters of bone health for premenopausal women. Premenopausal women will be assigned into either the training or control groups, based on geographical location and their willingness to participate in the regular (2-5 times/week) jump-landing programme (in their own homes), and attend jump-landing group classes regularly. The participants in the training group will be recruited within the Bay of Plenty area for the following reasons; a) to enable participation in weekly group jumping classes, b) to be available for regular testing sessions, and c) to improve compliance over the course of the 12-month study. The control group will not be performing the jump-landing programme and will be asked to maintain their normal physical activity. The jump-landing programme utilises the training principles and progression described for best practice in strength and conditioning. Data will be collected using dual energy X-ray absorptiometry (DEXA) utilising specialised hip structural analysis (HSA) software. Data will be compared using repeated measures ANOVA and effect statistics.
Evidence from this study has potential to inform future exercise recommendations used to improve bone health during the critical premenopausal period, and both reduce and delay the incidence of osteoporotic fracture in the years post menopause.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76626 0
Ms Tracey Clissold
Address 76626 0
Toi Ohomai Institute of Technology
Windemere Campus
Sport and Recreation
Private Bag 12001
Tauranga 3143
Country 76626 0
New Zealand
Phone 76626 0
+64 21 2097022
Fax 76626 0
Email 76626 0
[email protected]
Contact person for public queries
Name 76627 0
Ms Tracey Clissold
Address 76627 0
Toi Ohomai Institute of Technology
Windemere Campus
Private Bag 12001
Tauranga 3143
Country 76627 0
New Zealand
Phone 76627 0
+64 7 557 8681
Fax 76627 0
Email 76627 0
[email protected]
Contact person for scientific queries
Name 76628 0
Prof John Cronin
Address 76628 0
Auckland University of Technology
AUT North Campus
90 Akoranga Drive
Northcote
Auckland
Country 76628 0
New Zealand
Phone 76628 0
+ 64 9 921 9999 ext. 7523
Fax 76628 0
Email 76628 0
[email protected]

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