Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001209684
Ethics application status
Approved
Date submitted
24/09/2023
Date registered
23/11/2023
Date last updated
29/02/2024
Date data sharing statement initially provided
23/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The CHILL BONES trial: testing Tai Chi and high intensity resistance and impact training (HiRIT) as therapy for older adults with low bone mass.
Scientific title
A semi-randomised controlled trial investigating the effect of Tai Chi combined with high-intensity resistance and impact training (HiRIT) versus HiRIT alone on bone mass and autonomic nervous system activity in older adults with low bone mass.
Secondary ID [1] 309967 0
nil known
Universal Trial Number (UTN)
Trial acronym
CHILL BONES: Combining High-intensity Impact Loading and Lifting with mind-Body exercise for Optimisation of NErvous system and Skeletal health
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 330455 0
Osteopenia 330456 0
Autonomic Dysfunction 330457 0
Fracture 331571 0
Condition category
Condition code
Musculoskeletal 327303 327303 0 0
Osteoporosis
Physical Medicine / Rehabilitation 327307 327307 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Tai Chi
Participants will learn the 18 foundational movements of Shibashi style Tai Chi/Quigong. Progression will be achieved through altering the direction of exercise (incorporate multi-directional movements) and increasing the challenge to balance through modification of base of support (foot position).. The instructor will provide participants with a selection of exercise progressions for each movement, and they will be encouraged to progress their exercises as able.

Each week, participants will complete a 60-minute community-based Tai Chi group session, supervised by a qualified Tai Chi instructor, and an unsupervised, 30-minute session of home-based exercise with a standardised instructional video (delivered by the same instructor). The intervention will be performed on non-consecutive days over a period of 8 months. A participant logbook will be completed after every session, to monitor compliance.

Arm 2: HiRIT
A recognised bone-targeted program comprised of 5 sets of 5 repetitions of four exercises (jumping chin up with drop landing, back squat, overhead press, deadlift) will be completed. Resistance exercises will be progressed by gradually increasing the load over the first 2 months to achieve an intensity of 80-85% of 1 repetition maximum (1RM) (based on individual strength). The load for each exercise will continue to increase across the remainder of the intervention period, ensuring an intensity of 80-85% 1RM is maintained as participants adapt to the resistance exercise. The impact exercise (jumping chin up) will progress from a soft knee landing style to a stiff legged landing style, as able.

Each week, participants will complete two supervised, 30-minute sessions of HiRIT in a group setting, on the university campus. These sessions will be performed on non-consecutive days, supervised by a trained physiotherapist for a period of 8 months. A participant logbook will be completed after every session, to monitor compliance and progression.

Arm 3: Combined Tai Chi + HiRIT
As this is a combined intervention, participants will undertake all components of Arm 1 and Arm 2 (Tai Chi and HiRIT) for the 8-month intervention period. Participants will complete HiRIT (30 mins) followed by supervised community-based Tai Chi (60 mins) once per week. They will also complete a second HiRIT session (30 mins) followed by an unsupervised home-based Tai Chi session (30 mins) performed with the same instructional video as per Arm 1. Each intervention day will be separated by at least 24 hours.
Progressions for each intervention are as per Arm 1 and Arm 2. A participant logbook will be completed after every session to monitor compliance and progression.
Intervention code [1] 327074 0
Treatment: Other
Intervention code [2] 327075 0
Lifestyle
Comparator / control treatment
Arm 4: Self-selected, non-exercising control
A non-randomised sample of participants who do not wish to undertake exercise or are unable to exercise, will be allocated to the control group, and asked to continue with their usual lifestyle activities for the 8-month intervention period. Weekly email contact and an online participant logbook will be used to track alterations in lifestyle habits over this period, in addition to reporting falls and fracture.
Control group
Active

Outcomes
Primary outcome [1] 336154 0
Total hip aBMD (g/cm2) measured by Dual-energy X-ray Absorptiometry (DXA)
Timepoint [1] 336154 0
Baseline (pre-intervention) and 8 months (post-intervention).
Secondary outcome [1] 427146 0
Lumbar spine (L1-4) aBMD (g/cm2) measured by DXA
Timepoint [1] 427146 0
Baseline (pre-intervention) and 8 months (post-intervention).
Secondary outcome [2] 427147 0
Volumetric indices of bone strength, measured using peripheral quantitative computed tomography (pQCT)
Timepoint [2] 427147 0
Baseline (pre-intervention) and 8 months (post-intervention).
Secondary outcome [3] 427148 0
Geometric indices of bone strength, measured by pQCT
Timepoint [3] 427148 0
Baseline (pre-intervention) and 8 months (post-intervention).
Secondary outcome [4] 427149 0
Appendicular skeletal muscle mass, measured using DXA
Timepoint [4] 427149 0
Baseline (pre-intervention) and 8 months (post-intervention).
Secondary outcome [5] 427150 0
Total fat mass, measured using DXA
Timepoint [5] 427150 0
Baseline (pre-intervention) and 8 months (post-intervention).
Secondary outcome [6] 427151 0
Calf muscle mass, measured using pQCT
Timepoint [6] 427151 0
Baseline (pre-intervention) and 8 months (post-intervention).
Secondary outcome [7] 427152 0
Calf muscle density, measured using pQCT
Timepoint [7] 427152 0
Baseline (pre-intervention) and 8 months (post-intervention).
Secondary outcome [8] 427153 0
Beat-to-beat blood pressure (tonic and reflexive), measured using Finapres Nova
Timepoint [8] 427153 0
Baseline (pre-intervention) and 8 months (post-intervention).
Secondary outcome [9] 427154 0
Heart rate variability (tonic and reflexive), measured using ECG
Timepoint [9] 427154 0
Baseline (pre-intervention) and 8 months (post-intervention).
Secondary outcome [10] 427155 0
Skin Sympathetic Nerve Activity (SKNA) (tonic and reflexive), measured using neuECG.
Timepoint [10] 427155 0
Baseline (pre-intervention) and 8 months (post-intervention).
Secondary outcome [11] 427156 0
Galvanic Skin Response (tonic and reflexive), measured using Galvanic Skin Response amplifier and finger electrodes.
Timepoint [11] 427156 0
Baseline (pre-intervention) and 8 months (post-intervention).
Secondary outcome [12] 427158 0
Lower limb muscle strength, measured using five times sit to stand test (previously validated techniques).
Timepoint [12] 427158 0
Baseline (pre-intervention) and 8 months (post-intervention).
Secondary outcome [13] 427159 0
Upper limb muscle strength, measured using handheld dynamometer.
Timepoint [13] 427159 0
Baseline (pre-intervention) and 8 months (post-intervention).
Secondary outcome [14] 427160 0
Functional performance measured by previously validated technique (Timed Up and Go test).
Timepoint [14] 427160 0
Baseline (pre-intervention) and 8 months (post-intervention).
Secondary outcome [15] 427161 0
Dynamic balance measured using a previously validated technique (Functional Gait Assessment).
Timepoint [15] 427161 0
Baseline (pre-intervention) and 8 months (post-intervention).
Secondary outcome [16] 428613 0
Compliance to the intervention, assessed through training diaries and monitoring across intervention period.
Timepoint [16] 428613 0
Weekly for each intervention arm, across the entire intervention period (8 months).
Secondary outcome [17] 428614 0
Total number of falls, fracture, and musculoskeletal injuries assessed through diaries and monitoring across the intervention period.
Timepoint [17] 428614 0
Weekly for each study arm, across the entire intervention period (8 months).
Secondary outcome [18] 428615 0
Daily average calcium intake measured using the validated AusCal questionnaire
Timepoint [18] 428615 0
Baseline (pre-intervention) and 8 months (post-intervention).
Secondary outcome [19] 428616 0
Patient Health Questionnaire-9 (PHQ-9) scores
Timepoint [19] 428616 0
Baseline (pre-intervention) and 8 months (post-intervention).
Secondary outcome [20] 428617 0
Historical bone-relevant loading measured using a validated tool 'bone-specific physical activity questionnaire (BPAQ)'
Timepoint [20] 428617 0
Baseline (pre-intervention) and 8 months (post-intervention).
Secondary outcome [21] 428618 0
Quality of life measured using the validated tool 'AQoL-8D'.
Timepoint [21] 428618 0
Baseline (pre-intervention) and 8 months (post-intervention).
Secondary outcome [22] 428619 0
Fear of falling measured by a validated tool 'Falls Efficacy Scale International'.
Timepoint [22] 428619 0
Baseline (pre-intervention) and 8 months (post-intervention).

Eligibility
Key inclusion criteria
Community-dwelling older adults over the age of 60 years, with low bone mass (T-score <-1.0 at hip or lumbar spine). Participants are otherwise healthy. They do not require a walking aid and are able to participate in an 8-month exercise intervention, twice per week.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- < 5 years post menopause
- Medications/conditions that influence bone health (i.e Selective serotonin reuptake inhibitors, corticosteroids, Paget’s disease, anabolic osteoporosis medication, hyperparathyroidism)
- Malignancy
- Uncontrolled cardiovascular disease
- Pacemaker
- Recent fracture, surgery or pain that prevents participation in exercise
- Radiation exposure
- Bilateral metal hip implants, lumbar spine implant
- Current resistance training, impact training or Tai Chi
- Cognitive impairment
- Unwilling/unable to participate in exercise intervention
- Hernia, retinal detachment

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1. Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
2. Stratification variable is sex and beta-blocker use
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated based upon data from a similar study, which examined bone mineral density (BMD) in post-menopausal women who participated in a resistance and impact training intervention (Bolton et al., 2012). The minimum sample size required to detect a mean difference in total hip (TH) BMD of 0.004 with a standard deviation (SD) of 0.012 at 80% power and alpha of 0.05 for a repeated measures Analysis of Variance (ANOVA) with 4 groups (between factor) and 2 measurement time-points (within factor) is 142 (n=36 per group). Accounting for a potential 20% attrition rate, the minimum number required for each group will be n=42. As there is currently a lack of data available pertaining to the autonomic outcomes used within this study, we have opted for a conservative effect size of 0.2. With this effect size, our estimated sample size (from above) is powered to detect differences in the autonomic outcomes.

SPSS V 28.0 (SPSS, Chicago, Illinois, USA) statistical package will be used for all statistical analyses. Descriptive statistics will be generated for participant characteristics, anthropometric and dependant variable data. One-way ANOVA will be used to determine whether there are any between group differences in baseline measures (Beck Depression Inventory score, calcium intake, baseline bone-specific physical activity, compliance, and age) and will be adjusted as necessary. Repeated measures ANOVA will then be used to detect differences in BMD change, change in other indices of fracture risk, and/or change in autonomic activity between groups over time. Intervention compliance and safety will also be assessed. Both intention-to-treat and per-protocol analyses (those who maintain 80% compliance) will be carried out. Statistical significance will be set to p<0.05 for all analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/10/2023
Date of last participant enrolment
Anticipated
25/11/2024
Actual
Date of last data collection
Anticipated
30/07/2025
Actual
Sample size
Target
168
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 314140 0
University
Name [1] 314140 0
Griffith University
Country [1] 314140 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
School of Health Sciences and Social Work, Griffith University, Gold Coast Campus, Parklands Drive, Southport, QLD, 4215
Country
Australia
Secondary sponsor category [1] 316061 0
None
Name [1] 316061 0
Address [1] 316061 0
Country [1] 316061 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313276 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 313276 0
Ethics committee country [1] 313276 0
Australia
Date submitted for ethics approval [1] 313276 0
09/06/2023
Approval date [1] 313276 0
23/06/2023
Ethics approval number [1] 313276 0
2023/448

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

Contacts
Principal investigator
Name 127574 0
A/Prof Benjamin Weeks
Address 127574 0
School of Health Sciences and Social Work, Griffith University, Gold Coast Campus Parklands Drive, Southport, QLD, 4215
Country 127574 0
Australia
Phone 127574 0
+610755529336
Fax 127574 0
Email 127574 0
[email protected]
Contact person for public queries
Name 127575 0
Jayde Collier
Address 127575 0
School of Health Sciences and Social Work, Griffith University, Gold Coast Campus Parklands Drive, Southport, QLD, 4215
Country 127575 0
Australia
Phone 127575 0
+610466463533
Fax 127575 0
Email 127575 0
[email protected]
Contact person for scientific queries
Name 127576 0
Benjamin Weeks
Address 127576 0
School of Health Sciences and Social Work, Griffith University, Gold Coast Campus Parklands Drive, Southport, QLD, 4215
Country 127576 0
Australia
Phone 127576 0
+610755529336
Fax 127576 0
Email 127576 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20998Study protocolOnce published  



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.