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Trial registered on ANZCTR


Registration number
ACTRN12617001166369
Ethics application status
Approved
Date submitted
21/07/2017
Date registered
8/08/2017
Date last updated
8/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of Flywheel Resistance Training on Balance Performance in Older Adults.
Scientific title
Efficacy of Flywheel Resistance Training on Balance Performance in Older Adults. A Randomized controlled trial
Secondary ID [1] 292495 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor balance 304132 0
Condition category
Condition code
Physical Medicine / Rehabilitation 303467 303467 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Before starting the training program, subjects completed two familiarization sessions that consisted of a review of safety guidelines, adjusting a harness to each participant’s leg length, and practice with the squat training device (kBox 3, Exxentric AB TM, Bromma, Sweden) equipped with one flywheel with a moment inertia of 0.025 kg m-2 (after week 4 a flywheel with a moment inertia of 0.05 kg m-2 was used). Similar to procedures reported elsewhere, participants then underwent six weeks of flywheel resistance training two (week 1, 3, 5) or three (week 2, 4, 6) times a week with at least 48 h of rest between sessions. Participants performed four sets of nine repetitions: two repetitions at the beginning of each set to initiate the flywheel movement and then seven maximal bilateral repetitions accelerating the wheel in the concentric action and, upon completion (when the flywheel strap winds back due to inertial forces), decelerating the wheel by means of an eccentric action. The rest interval between sets was 3 min. Mean Propulsive Velocity (MPV) and average power output were measured during each concentric action (SmartCoachTM Power Encoder, SmartCoach Europe AB, Stockholm, Sweden) and real-time feedback was provided on a computer monitor with the associated software. Research personnel gave verbal encouragement during all repetitions performed. Attendance at training sessions will also be registered.
Intervention code [1] 298678 0
Rehabilitation
Intervention code [2] 298767 0
Treatment: Devices
Comparator / control treatment
Control group participants continued with their typical daily activities that included employment or leisure activities but did not include regular exercise training
Control group
Active

Outcomes
Primary outcome [1] 302836 0
Balance (force platform)
Timepoint [1] 302836 0
Pre and Post (week 6)
Secondary outcome [1] 337197 0
Mobility (TUG)
Timepoint [1] 337197 0
Pre and Post (week 6)
Secondary outcome [2] 337198 0
Strength (concentric, eccentric, isometric) by means of Isokinetic dynamometry
Timepoint [2] 337198 0
Pre and Post (week 6)
Secondary outcome [3] 337503 0
Strength (Sit and Stand)
Timepoint [3] 337503 0
Pre and post (6 weeks)

Eligibility
Key inclusion criteria
Participants >60 years of age who had not been engaged in any regular or systematic exercise-training program in the previous 12 months.
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals, who had to be older than 60 years-of-age, were excluded if they had cognitive or functional disorders that adversely impacts skeletal muscle function or manifests in a mobility disorder.

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 was performed by a member of the research team who was not directly-involved in the recruitment or assessment of participants using a computer generated random allocation data processing program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1:1 ratio (ETG:CON).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
Descriptive statistics were calculated for demographic variables and dependent measures. All data were first log-transformed to reduce bias and then, the standardised difference or effect size (ES, 90% confidence limit) of the selected variables was calculated using the pooled pretraining SD. The threshold values used for ES were >0.2 (small), >0.6 (moderate) and >1.2 (large). For within/between-groups comparisons, the chances that the differences in performance were better/greater, similar, or worse/smaller as well as the quantitative chances (beneficial/better or detrimental/poorer effect) were calculated as follows: <1%, almost certainly not; 1% to 5%, very unlikely; 5% to 25%, unlikely; 25% to 75%, possibly; 75% to 95%, likely; 95% to 99%, very likely and >99%, almost certainly. If the chances of having beneficial/better and detrimental/poorer performances were both >5% then the true difference was considered to be unclear.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9078 0
Spain
State/province [1] 9078 0

Funding & Sponsors
Funding source category [1] 297063 0
University
Name [1] 297063 0
University of Seville
Address [1] 297063 0
Facultad de Ciencias de la Educación, C/ Pitotécnia s/n. E-41013, Seville (Spain)
Country [1] 297063 0
Spain
Primary sponsor type
University
Name
University of Seville
Address
Facultad de Ciencias de la Educación (Universidad de Sevilla), C/ Pitotécnia s/n. E-41013, Seville (Spain).
Country
Spain
Secondary sponsor category [1] 296153 0
None
Name [1] 296153 0
NONE
Address [1] 296153 0
NONE
Country [1] 296153 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298247 0
University of Seville
Ethics committee address [1] 298247 0
Ethics committee country [1] 298247 0
Date submitted for ethics approval [1] 298247 0
Approval date [1] 298247 0
01/07/2016
Ethics approval number [1] 298247 0

Summary
Brief summary
The efficacy of strength training using inertial devices on balance in older adults is largely unknown. This study aimed to assess the effects of flywheel resistance exercise training (FRET) on postural stability and mobility in older adults and to investigate whether changes in leg power are related to improvements in balance. Study Design: RCT. Methods: Thirty-six individuals will be randomly allocated to either a FRET group (ETG) who will underwent 6-weeks of training (4x9 reps on a squat device, 2-3 times/week) or usual-care control group (CON; n = 18). Measures: During each repetition, the average power and Mean Propulsive Velocity (MPV) will be computed. The Timed up-and-go test (TUG) and postural balance (anterior–posterior (AP) and medial–lateral (ML) center of pressure (COP) excursions) in different tasks and muscle strength will be assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76462 0
Dr Borja Sañudo
Address 76462 0
Facultad de Ciencias de la Educación (Universidad de Sevilla), C/ Pitotécnia s/n. E-41013, Seville (Spain).
Country 76462 0
Spain
Phone 76462 0
+34652387090
Fax 76462 0
Email 76462 0
bsancor@us.es
Contact person for public queries
Name 76463 0
Dr Borja Sañudo
Address 76463 0
Facultad de Ciencias de la Educación (Universidad de Sevilla), C/ Pitotécnia s/n. E-41013, Seville (Spain).
Country 76463 0
Spain
Phone 76463 0
+34652387090
Fax 76463 0
Email 76463 0
bsancor@us.es
Contact person for scientific queries
Name 76464 0
Dr Borja Sañudo
Address 76464 0
Facultad de Ciencias de la Educación (Universidad de Sevilla), C/ Pitotécnia s/n. E-41013, Seville (Spain).
Country 76464 0
Spain
Phone 76464 0
+34652387090
Fax 76464 0
Email 76464 0
bsancor@us.es

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary