Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001176752
Ethics application status
Approved
Date submitted
21/10/2013
Date registered
28/10/2013
Date last updated
4/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the psychological and physiological efficacy of an exercise intervention in aged individuals: Is there a role for core-stability training?
Scientific title
Assessing the psychological and physiological effects of an exercise intervention in aged individuals: Is there a role for core-stability training? A randomized controlled trial
Secondary ID [1] 283046 0
None
Universal Trial Number (UTN)
U1111-1146-9792
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-related loss of skeletal muscle mass (sarcopenia)
 290307 0
Risk of falls 290357 0
Fear of falling 290358 0
Condition category
Condition code
Musculoskeletal 290247 290247 0 0
Other muscular and skeletal disorders
Mental Health 290248 290248 0 0
Depression
Mental Health 290249 290249 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following baseline data collection, participants will be randomized to one of two groups (32 per group) using a computer-generated block randomisation list with random block sizes of 2, 4, or 6. Sequentially numbered, opaque envelopes containing the participant’s group assignment will be prepared by research staff not affiliated with delivery of the exercise program. The group allocation will be conducted by the same researcher and occurred after completion of baseline assessments. Group allocations will be concealed from participants and research assistants.
Training: all exercise training sessions will be conducted and supervised in the Rehabilitation, Strength and Conditioning Laboratory (Sport Science Laboratories), at Murdoch University, Perth, Western Australia. Each exercise program involves 12 weeks of training. The training intervention will comprise a multimodal exercise program (walking-balance), with or without trunk strengthening/motor control exercises. Participants will attend three sessions of 45-minutes each that will be fully administered and supervised by qualified exercise scientist. Exercise difficulty will be progressed over the course of the programme. Programme adherence is defined a priori as participating in at least 80% of the exercise sessions.
Detraining: following completion of the 12-week exercise program, participants in both groups will be instructed to continue with a walking-only program over the subsequent 6 weeks. A walking-only program was adopted and termed the ‘detraining phase’, because walking has no apparent effect on the main outcome measures of the trial, namely trunk muscle morphology (1) size or most (except 6-minute walk test) functional tasks adopted in the current study.

(1) Shahtahmassebi B, Hebert JJ, Stomski NJ, Hecimovich M, Fairchild TJ. The effect of exercise training on lower trunk muscle morphology. Sports
Intervention code [1] 287776 0
Prevention
Comparator / control treatment
The control group will receive a cardiovascular exercise program consisting of walking (indoor cycling will be used on days where it is deemed unsuitable to go outdoors) at approximately 60% of heart rate max.

Detraining sessions will be run for 12 weeks in small group sessions, 3 times a week for 45-minutes that fully administered and supervised by qualified exercise scientist.

A walking program has been used as the “control” group since walking is not expected to change the size or strength of the muscles being targeted (trunk muscles).

Motivation/adherence/ compliance strategies: Every participant of the control group received a multimodal training after the post-measurements.
Control group
Active

Outcomes
Primary outcome [1] 290279 0
- Trunk muscle size: Transversus abdominis, Internal and external oblique, Rectus abdominis, and Lumbar multifidus (Diagnostic ultrasound)
Timepoint [1] 290279 0
At baseline, week 6, week 12 and week 18
Primary outcome [2] 290420 0
Trunk muscle strength: Maximal voluntary isometric strength of the trunk flexors/extensors/lateral flexors (right, left) (HUMAC NORM Isokinetic device)
Timepoint [2] 290420 0
At baseline, week 6, week 12 and week 18
Primary outcome [3] 290421 0
Falls-risk (FROP-COM scale)
Timepoint [3] 290421 0
At baseline, week 6, week 12 and week 18
Secondary outcome [1] 304480 0
Static balance (Berg balance scale)
Timepoint [1] 304480 0
At baseline, week 6, week 12 and week 18
Secondary outcome [2] 305166 0
Dynamic balance (Four Step Square Test)
Timepoint [2] 305166 0
At baseline, week 6, week 12 and week 18
Secondary outcome [3] 305167 0
Mobility (Tmed Up and Go)
Timepoint [3] 305167 0
At baseline, week 6, week 12 and week 18
Secondary outcome [4] 305191 0
30 seconds Chair Stand Test
Timepoint [4] 305191 0
At baseline, week 6, week 12 and week 18
Secondary outcome [5] 305192 0
Activities of daily living (Lawton Instrumental Activities of Daily Living)
Timepoint [5] 305192 0
At baseline, week 6, week 12 and week 18
Secondary outcome [6] 305193 0
Quality of life (SF-36)
Timepoint [6] 305193 0
At baseline, week 6, week 12 and week 18
Secondary outcome [7] 305197 0
Depression (Geriatric Depression Scale)
Timepoint [7] 305197 0
At baseline, week 6, week 12 and week 18
Secondary outcome [8] 305198 0
Anxiety (Geriatric Anxiety Inventory)
Timepoint [8] 305198 0
At baseline, week 6, week 12 and week 18
Secondary outcome [9] 305199 0
Level of concern about falling (Falls Efficacy Scale)
Timepoint [9] 305199 0
At baseline, week 6, week 12 and week 18
Secondary outcome [10] 305200 0
Fear of falling (Fear of Falling questions)
Timepoint [10] 305200 0
At baseline, week 6, week 12 and week 18
Secondary outcome [11] 351469 0
Sitting and Rising Test
Timepoint [11] 351469 0
At baseline, week 6, week 12 and week 18
Secondary outcome [12] 351470 0
Accelerometer measurement. (ActiGraphiGT3X)
Timepoint [12] 351470 0
At baseline, week 6, week 12 and week 18
Secondary outcome [13] 351471 0
Six Minute Walk Test
Timepoint [13] 351471 0
At baseline, week 6, week 12 and week 18
Secondary outcome [14] 351472 0
The Multi-Directional Reach Test
Timepoint [14] 351472 0
At baseline, week 6, week 12 and week 18

Eligibility
Key inclusion criteria
A group of aged (> 59 years of age female and male adults
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- A history of lumbar surgery
- Any medical condition and prescribed medication which may preclude safe participation in an exercise intervention
- Unable to communicate and fill in the questionnaires in English
- If individuals tick "yes" to any of the first seven questions in stage one of the ESSA screening tool, they will be referred to their physician for clearance prior to participation in this exercise training study.

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)
Using sealed, sequentially numbered envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocations randomly generated by a computer programme
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data management and statistical analyses were performed using IBM SPSS version 22.0 software (IBM Corp, Armonk, NY). The primary outcomes were trunk muscle morphology, strength, functional and psychological outcomes. Treatment effects were estimated with separate, random-intercept linear mixed models for each outcome variable. Time [baseline (week 0), 6 weeks, 12 weeks, 18 weeks] and exercise group (trunk strengthening, walking-balance) were modelled as fixed effects. We entered the baseline score of the outcome variable as a covariate in each model. The hypothesis of interest was the time by group interaction, which was examined with pairwise comparisons of the estimated marginal means. Consistent with the intention-to-treat principle, the linear mixed models estimated values for missing data based on the available scores; therefore, all participants were included in the analyses. The level of significance was set at p =0.05.

An a priori power analysis revealed 64 participants (32 per group) would be required to detect a small-moderate effect (f = 0.165; type I error = 0.05; type II error = 0.80) between 2 groups assuming 4 repeated measurements with a correlation between measures of 0.50 and an anticipated 20% dropout rate. The effect size was computed from changes in trunk muscle morphology (abdominal muscle morphology) following an exercise training intervention (1).

(1) Critchley DJ, Pierson Z, Battersby G. Effect of pilates mat exercises and conventional exercise programmes on transversus abdominis and obliquus internus abdominis activity: pilot randomised trial. Manual therapy. 2011;16(2):183-189

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/12/2013
Actual
14/02/2014
Date of last participant enrolment
Anticipated
Actual
21/05/2015
Date of last data collection
Anticipated
Actual
28/09/2015
Sample size
Target
66
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 287911 0
University
Name [1] 287911 0
School of Psychology and Exercise Science
Murdoch University, Perth, Western Australia
Country [1] 287911 0
Australia
Primary sponsor type
Individual
Name
Behnaz Shahtahmassebi
Address
School of Psychology and Exercise Science, Murdoch University, Social Sciences Building 440, Room 3.001, 90 South Street, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 286640 0
University
Name [1] 286640 0
School of Psychology and Exercise Science
Murdoch University, Perth, Western Australia
Address [1] 286640 0
School of Psychology and Exercise Science, Murdoch University, South Street campus, Murdoch University, 90 South Street, Murdoch, Perth, Western Australia 6150
Country [1] 286640 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294645 0
Murdoch University Research Ethics Committee
Ethics committee address [1] 294645 0
Ethics committee country [1] 294645 0
Australia
Date submitted for ethics approval [1] 294645 0
29/07/2013
Approval date [1] 294645 0
14/11/2013
Ethics approval number [1] 294645 0
2013/140

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

Contacts
Principal investigator
Name 42278 0
Dr Timothy Fairchild
Address 42278 0
School of Psychology and Exercise Science, Murdoch University
Room 4.016, Economics, Commerce and Law Building, 90 South Street, Murdoch WA 6150
Country 42278 0
Australia
Phone 42278 0
+6189360 2959
Fax 42278 0
Email 42278 0
[email protected]
Contact person for public queries
Name 42279 0
Timothy Fairchild
Address 42279 0
School of Psychology and Exercise Science, Murdoch University
Room 4.016, Economics, Commerce and Law Building, 90 South Street, Murdoch WA 6150
Country 42279 0
Australia
Phone 42279 0
+6189360 2959
Fax 42279 0
Email 42279 0
[email protected]
Contact person for scientific queries
Name 42280 0
Timothy Fairchild
Address 42280 0
School of Psychology and Exercise Science, Murdoch University
Room 4.016, Economics, Commerce and Law Building, 90 South Street, Murdoch WA 6150
Country 42280 0
Australia
Phone 42280 0
+6189360 2959
Fax 42280 0
+6189360 6878
Email 42280 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.