Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001177145
Ethics application status
Approved
Date submitted
7/08/2019
Date registered
20/08/2019
Date last updated
28/04/2022
Date data sharing statement initially provided
20/08/2019
Date results provided
28/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Kettlebell training with insufficiently active older adults
Scientific title
Effects of supervised high-intensity hardstyle kettlebell training on grip strength and health-related physical fitness in insufficiently active older adults: the BELL pragmatic controlled trial
Secondary ID [1] 298947 0
None
Universal Trial Number (UTN)
U1111-1238-0912
Trial acronym
BELL
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Ageing 313931 0
Physical inactivity 314024 0
Condition category
Condition code
Physical Medicine / Rehabilitation 312337 312337 0 0
Physiotherapy
Mental Health 312338 312338 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 weeks progressive hardstyle kettlebell training, performed 3-times weekly for 45 minutes (including a warm-up and cool-down period) on non-consecutive days in a supervised group setting, and two prescribed but self-paced sessions at home.

Supervised group training is conducted face-to-face, led by a Physiotherapist and certified hardstyle kettlebell instructor (RKC). Training is based upon but not limited to, the kettlebell swing, clean, press, squat, snatch and Turkish get-up. A familiarisation week (3x 45min sessions on non-consecutive days) will take place prior to commencement of training. This will introduce participants to the exercises and technique and involve no load or low-load only.

During week 1 of training, participants will perform relatively low intensity (light weight kettlebell) low volume exercises to minimise the likelihood of experiencing delayed onset muscle soreness. Intensity throughout the program will not be determined by participant’s functional capacity (1RM kettlebell deadlift). Participants will determine exercise intensity (kettlebell weight) based on self-determined physical and psychological comfort. Participants will however receive frequent encouragement to work at a moderate to high intensity, with the aim of increasing intensity and/or volume between sessions.

It is anticipated that session Rating of Perceived Exertion (RPE) will be around 15 on a 6-20 point Borg scale (described as “hard”) from week 2 onward. Classes will involve a range of whole-body exercises involving high repetitions, with ample time given between sets for participants to feel sufficiently rested. Recommendation to increase intensity (bell weight) will be given if RPE appears low to moderate and technique is acceptable. Adherence and training load are monitored with training logs completed during and after each session. A nominal score of mean training intensity for the session (session-Rate of Perceived Exertion - sRPE) will be obtained from each participant after every training session using a modified CR-10 scale (0-10, 5 = “hard”). Participants will be familiarised with the scale according to standard procedures before commencing the study.

Supervised group training will be augmented by two non-consecutive days of prescribed, self-paced home exercises. These are intended to improve motor patterning (technique), increase chronic training load volume and help develop a habit. Home exercises have not been set a-priori however all participants will receive an 8kg kettlebell for their home exercise. Example home exercise may include: accrue at least 50 deadlifts or 30 chair squats (with or without load) throughout the course of the day; perform (practice) 10 floor transfers (Turkish get-ups) without weight as described; accrue at least 5 minutes of walking while holding the 8kg kettlebell.

The exercise intervention will be described in detail according to the exercise-specific Consensus on Exercise Reporting Template (CERT) and Template for Intervention Description and Replication (TIDieR) checklist. A completed CERT and TIDieR checklist will be available as extended data.

Normal variation in physical capacity and movement competency may require that some exercises are modified based on individual requirements. Consistent with strategies to improve adherence within community-based group exercise programs, participants will receive regular positive encouragement (individually and as a group), with particular focus on maintaining their training diary, providing individual and group recognition of attaining new personal bests, and promoting a spirit of competition within the group. Attendance will be recorded and form part of the adherence analysis, together with reasons for non-attendance. Participants will be asked to bring with them a record of home exercise(s) completed, which will be captured and recorded for analysis.
Intervention code [1] 315217 0
Prevention
Intervention code [2] 315219 0
Lifestyle
Comparator / control treatment
8 weeks usual sedentary activity (controlled period of no intervention) immediately preceding commencement of intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320965 0
Hand grip strength measured with an isometric dynamometer (Jamar handheld dynamometer, Sammons Preston Roylan, Bolingbrook, IL) using a modified Southampton protocol recommended for the elderly. Southampton protocol available as extended data.
Timepoint [1] 320965 0
Change from 0 to 17 weeks. Assessed at 0, week 9 and week 17.
Secondary outcome [1] 373534 0
Change in 6-minute walk distance (6MWD) will be measured using the 6-minute walk test, conducted according to the American Thoracic Society guidelines.
Timepoint [1] 373534 0
Change from 0 to 17 weeks. Assessed at 0, week 9 and week 17.
Secondary outcome [2] 373535 0
Change in 30 second sit-to-stand test (30sSTS)
Timepoint [2] 373535 0
Change from 0 to 17 weeks. Assessed at 0, week 9 and week 17.
Secondary outcome [3] 373536 0
Change in submaximal aerobic capacity using the Stair-climbing test (SCT). Participants will climb seven flights of stairs having a 34 degree inclination. Four flights have 15 steps, 3 flights have 6 steps (totalling 78 steps), and there are approximately 21 steps on level ground between flights. Step height measures 17.5cm (total vertical displacement during the test is 13.65m). Participants will be instructed to climb all the steps in the shortest time possible, with standardized verbal encouragement at each flight, given by the same examiner. Participants will be asked to not use the handrail unless necessary. The time taken to climb the total height will be designated the stair-climb time and will be recorded in seconds (s). Heart rate will be recorded before and after the test using a heart rate monitor measured by transcutaneous pulse oximetry (Prince-100A Fingertip Oximeter; Shanghai Lishen Scientific Equipment Co, Ltd., Qingpu, Shanghai, People’s Republic of China). Each participant will undergo the test only once during each testing phase.
Timepoint [3] 373536 0
Change from 0 to 17 weeks. Assessed at 0, week 9 and week 17.
Secondary outcome [4] 373537 0
Change in fingertip-to-floor distance (FTF). Participants will stand erect on a platform 20-cm high with shoes removed and feet together. The participant will be asked to bend forward as far as possible, while maintaining the knees, arms, and fingers fully extended. The vertical distance between the tip of the middle finger and the platform will be measured with a supple tape measure and expressed in centimetres.
Timepoint [4] 373537 0
Change from 0 to 17 weeks. Assessed at 0, week 9 and week 17.
Secondary outcome [5] 373538 0
Change in lean tissue mass (Dual energy X-ray absorptiometry: DXA). Body composition will be measured using a narrow angle fan beam Lunar Prodigy DXA machine (GE Healthcare, Madison, WI, USA) and Nana positioning protocol. Automatic analysis will be performed using GE enCore 2016 software (GE Healthcare).
Timepoint [5] 373538 0
Change from 0 to 17 weeks. Assessed at 0, week 9 and week 17.
Secondary outcome [6] 373539 0
Change in lean tissue mass (Bioelectrical Impedance Analysis: BIA). BIA data will be collected using the Tanita MC-980MA PLUS (Tanita Body Composition Analyzer MC-980MA, Illinois, USA) and the assessment conducted as previously described using the same machine. Raw measures from the device and the cross-validated Sergi equation will be used for standardization as recommended in older populations.
Timepoint [6] 373539 0
Change from 0 to 17 weeks. Assessed at 0, week 9 and week 17.
Secondary outcome [7] 373540 0
Change in hip extension strength. Hip extension strength (hip extensor torque) will be assessed using a modified procedure previously validated in older women. Participants will be lying supine on a plinth with their pelvis firmly secured with a strap. The participants heel will be suspended by a strap such that it is positioned 8cm above the plinth. A calibrated and zeroed load cell will be situated between the ankle strap and a fixed attachment overhead. Participants will be asked to push their heel toward the plinth as hard as possible. Three attempts will be given on each limb, with the maximum reading from each limb recorded for analysis and expressed relative to bodyweight (BW) in N m/kg.
Timepoint [7] 373540 0
Change from 0 to 17 weeks. Assessed at 0, week 9 and week 17.
Secondary outcome [8] 373541 0
Change in knee extension strength. Knee extension strength (quadriceps torque) will be conducted used a modified procedure previously described. Participants will be seated on a purpose-build, non-height adjustable seat, without arm rests or backrest. The participants’ lower leg(s) will be supported by the seat in 60 degrees of knee flexion. After familiarization, subjects will be instructed to extend their leg against the strap with maximal force for 2 to 3 seconds. The thigh will be stabilized with a safety belt. A calibrated and zeroed load cell will be situated between a strap around the ankle of the testing limb and the rear of the seat, positioned roughly perpendicular to the angle of the lower leg. Each leg will be tested three times, unless there is a medical contraindication (e.g. prosthesis), and the highest value recorded for each and expressed relative to bodyweight (BW) in N m/kg.
Timepoint [8] 373541 0
Change from 0 to 17 weeks. Assessed at 0, week 9 and week 17.
Secondary outcome [9] 373542 0
Change in relative lower limb power will be calculated using the validated Sit To Stand (STS) iPhone App (version 1.0.8). Participant’s right femur length will be measured from the superior aspect of the greater trochanter to the lateral femoral condyle with a supple measuring tape. Participants will complete three STS repetitions recorded using the iPhone App installed on an iPhone 8 Plus, running iOS 12.2 (Apple Inc., USA). Each repetition will be recorded at 240 frames-per-second at a quality of 720 pixels. The iPhone will be positioned on a 0.7m-high tripod placed 3 m from the chair on the right side of the participant. Participants will sit on a rigid chair with their arms crossed over their chest with the hip, knee and ankle joints at approximately 90°, both feet rested on the floor.
Timepoint [9] 373542 0
Change from 0 to 17 weeks. Assessed at 0, week 9 and week 17.
Secondary outcome [10] 373543 0
Change in absolute lower limb power will be calculated with a counter-movement vertical jump using an AMTI force plate. The vertical component of the ground reaction force of the jumper will be sampled at 1000Hz and recorded by an IBM competitive PC with Windows 10 Enterprise operating system. Ground reaction force impulse is determined by calculating the area under the force-time curve by numerical integration. Height will be calculated by applying the impulse-momentum theorem to the force-time record, with data acquisition and analysis of the jumps performed using a custom program written program in MATLAB.
Timepoint [10] 373543 0
Change from 0 to 17 weeks. Assessed at 0, week 9 and week 17.
Secondary outcome [11] 373544 0
Change in quiet standing balance control will be evaluated from the excursion of the centre of pressure standing on a single force platform (AMTI Force Platform, Watertown, NY, USA). Wearing their usual footwear (flat-heeled closed-toe shoes) with feet together, participants will complete two measures; eyes open and eyes closed.
Timepoint [11] 373544 0
Change from 0 to 17 weeks. Assessed at 0, week 9 and week 17.
Secondary outcome [12] 373545 0
Change in functional capacity (1 repetition maximum: 1RM) will be assessed using a kettlebell deadlift. Participants will be presented with a line of kettlebells from 4 to 68kg in order of increasing weight. Standing directly over the kettlebell with feet set a comfortable width apart, and handle positioned on a line bisecting the middle of both feet. The participant will grasp the kettlebell handle with both hands then stand fully upright before returning the bell to the floor. Lifting coaching will not be provided. Participants will perform a single lift with each kettlebell until they feel unable to continue, or fail to perform a successful lift. If a participant can lift the 68kg kettlebell, they will be asked to perform as many repetitions as possible.
Timepoint [12] 373545 0
Change from 0 to 17 weeks. Assessed at 0, week 9 and week 17.
Secondary outcome [13] 373546 0
Change in functional mobility using the floor transfer test (FTT). When prompted, the participant will be asked to transfer themselves without any kind of support from standing to a supine position on the floor with hands lying flat on the floor and head resting on a pillow, as previously described. They will then return to standing upright in their own time. The time to complete 5 consecutive floor transfers will be recorded for analysis.
Timepoint [13] 373546 0
Change from 0 to 17 weeks. Assessed at 0, week 9 and week 17.
Secondary outcome [14] 373548 0
Change in resting blood pressure. Participants’ resting blood pressure will be taken using a routine clinic procedure. Participants will be asked to not smoke or consume tea and coffee for 30 minutes prior. Three measurements will be taken using a validated automated device [Vital Signs Monitor 300 Series, Welch Allyn, Ermington, NSW, Australia]. The average of three readings with 1-minute intervals will be recorded.
Timepoint [14] 373548 0
Change from 0 to 17 weeks. Assessed at 0, week 9 and week 17.
Secondary outcome [15] 373550 0
Change in health-related quality of life will be measured using the SF-36v2 questionnaire .
Timepoint [15] 373550 0
Change from 0 to 17 weeks. Assessed at 0, week 9 and week 17.
Secondary outcome [16] 373551 0
Change in sense of coherence will be measured using Antonovsky’s validated 13-item scale.
Timepoint [16] 373551 0
Change from 0 to 17 weeks. Assessed at 0, week 9 and week 17.

Eligibility
Key inclusion criteria
Living independently
Sedentary for 9 months or more
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Medical conditions or medications known to affect musculoskeletal health which limit the capacity to perform moderate to high intensity exercise
2. Recent surgery or trauma
3. Uncontrolled cardiovascular or respiratory disease
4. Engaged in a structured exercise program within the past 9 months
5. Malignancy
6. Unable to safely perform a floor transfer independently
7. Unable to comfortably lift the upper extremities overhead
8. Unexplained pain with fundamental movements/activities e.g. sitting, walking, lifting, carrying, pushing, pulling, twisting
9. Presence of hazards which would prevent body composition analysis such a pacemaker
10. Inability or unwillingness to take part in 8 weeks of three-times weekly exercise training due to motivation, travel, work or family commitments

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Repeated measures, pragmatic exercise trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A priori power analysis based on previous measurements revealed that 22 participants were required for 80 percent power (beta equal to 0.80), standard deviation of 1.0 with an effect size change in grip strength of 0.88, to test the null hypothesis of equality (alpha equal to 0.05). Allowing for a 30 percent drop-out rate during the trial period, we aim to recruit 30 participants. A 30 percent drop-out is not indicative of previous trials.

Data will be expressed as mean (standard deviation) for normally-distributed continuous variables or median (range) for skewed variables where non-normality could not be corrected through transformations. Normality will be checked through a combination of histograms, normal Q-Q plots and the Shapiro-Wilk test. Categorical variables will be summarised using frequencies and percentages. Continuous variables will be compared at baseline to assess any difference between gender and previous training history using the independent t-test, subject to normality assumptions, or the non-parametric alternative Mann-Whitney U test. Categorical variables will be compared at baseline between gender and training history, using the chi-square test. Linear mixed models (LMMs) will be applied to the 30 participants who will be measured at 3 time-points (baseline, week 9 and week 17) to model the change in all quantitative outcomes and to assess the effect of potential confounders, including previous training history. Mixed-effects regression is suitable in modelling repeated measures and missing data, should the latter arise. Time will be treated as a fixed factor to enable the assessment of any statistically significant changes between specific time-points. The individual will be treated as a random effect. Random intercepts, random slopes, polynomial models and interaction terms will be investigated to determine the most suitable models. The final models will be fitted using the restricted maximum likelihood estimation (REML) method. Residual diagnostics will be used to check distributional assumptions. Statistical significance will be set at the 0.05 level a priori. Statistical analyses will be carried out using SPSS. All participants for whom outcome measures are available will receive the treatment as allocated or, where this is not the case, data for at least one key outcome will be analysed by ‘intention to treat’.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/08/2019
Actual
21/08/2019
Date of last participant enrolment
Anticipated
1/11/2019
Actual
25/09/2019
Date of last data collection
Anticipated
Actual
22/05/2020
Sample size
Target
32
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment postcode(s) [1] 27450 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 303485 0
University
Name [1] 303485 0
Bond University
Country [1] 303485 0
Australia
Primary sponsor type
University
Name
Bond University
Address
14 University Dr,
Robina
QLD
4226
Country
Australia
Secondary sponsor category [1] 303544 0
Individual
Name [1] 303544 0
Neil J. Meigh
Address [1] 303544 0
Bond Institute of Health & Sport
2 Promethean Way
Robina
QLD
4226
Country [1] 303544 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304013 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 304013 0
Ethics committee country [1] 304013 0
Australia
Date submitted for ethics approval [1] 304013 0
19/06/2019
Approval date [1] 304013 0
30/07/2019
Ethics approval number [1] 304013 0
NM03279

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

Contacts
Principal investigator
Name 95562 0
Mr Neil Meigh
Address 95562 0
Bond Institute of Health & Sport
2 Promethean Way
Robina
QLD, 4226
Country 95562 0
Australia
Phone 95562 0
+61 421 922 221
Fax 95562 0
Email 95562 0
[email protected]
Contact person for public queries
Name 95563 0
Neil Meigh
Address 95563 0
Bond Institute of Health & Sport
2 Promethean Way
Robina
QLD, 4226
Country 95563 0
Australia
Phone 95563 0
+61 421 922 221
Fax 95563 0
Email 95563 0
[email protected]
Contact person for scientific queries
Name 95564 0
Neil Meigh
Address 95564 0
Bond Institute of Health & Sport
2 Promethean Way
Robina
QLD, 4226
Country 95564 0
Australia
Phone 95564 0
+61 421 922 221
Fax 95564 0
Email 95564 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?
Primary outcome data will be held on Open Science Framework storage. De-identified data and primary materials will be made openly available for use by other researchers and interested persons for further research, after a reasonable period following completion of the research. There are no provisions at this time for an embargo period.
When will data be available (start and end dates)?
On completion of the research project. No end date
Available to whom?
All
Available for what types of analyses?
Any
How or where can data be obtained?
Open Science Framework (OSF). Link to data stored on OSF will become available after publication.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3840Study protocolMeigh, N. (2022, April 26). The BELL Trial - PROTOCOL. https://doi.org/10.17605/OSF.IO/DZ96P   Open Science Framework (OSF). Link to study protoc... [More Details]
3841Statistical analysis plan    Open Science Framework (OSF). Link to statistical ... [More Details]
3842Informed consent form    Open Science Framework (OSF). Link to informed con... [More Details]
3843Ethical approval    Open Science Framework (OSF). Link to ethical appr... [More Details]
3844Analytic code    Open Science Framework (OSF). Link to analytic cod... [More Details]
3846Other    Explanatory statement Media release form Estimat... [More Details]



Results publications and other study-related documents

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