Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001175763
Ethics application status
Approved
Date submitted
21/10/2013
Date registered
28/10/2013
Date last updated
7/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving postural stability in people with Parkinson's disease: A randomised controlled trial
Scientific title
The effects of low-level supervision exercise on improving postural stability in people with Parkinson’s disease
Secondary ID [1] 283411 0
None
Universal Trial Number (UTN)
U1111-1149-2462
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postural instability 290333 0
Parkinson's disease 290361 0
Condition category
Condition code
Neurological 290735 290735 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 290753 290753 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
[Arm 1 - Exercise 1 day per week: Participants assigned to this intervention group will be asked to attend a supervised training session once a week for 12 weeks. The exercise program will target improving the strength and endurance of the muscles of the trunk. This session will be conducted as a group session and is expected to last up to 90 minutes. Outside of this single training session, participants will be asked to maintain their normal daily lives and not to partake in additional structured exercise. Participants will be asked to complete and submit a physical activity log once per week to facilitate the measurement of physical activity and to monitor compliance to the program. A weekly follow-up by telephone and/or email will also be used as a secondary means of ascertaining the participants’ compliance. Participants in this group will also receive the same weekly multidisciplinary health tips as the education group via their preferred method each week during the 12-week training program.]
Intervention code [1] 288145 0
Treatment: Other
Intervention code [2] 288146 0
Prevention
Comparator / control treatment
[Education (Control) Group: Participants assigned to this group will be encouraged to continue their day-to-day lives, as usual, but will receive a weekly multidisciplinary health tip for 12-weeks via their preferred method, (postal service or email) that will explain how, for example, exercise, nutrition and/or sleep quality may influence their falls risk and quality of life.]
Control group
Active

Outcomes
Primary outcome [1] 290733 0
[Primary outcome 1: Regularity of movement will be assessed during walking using 3D accelerometers. Measurements derived from the accelerometry data will include the 'harmonic ratio', which has previously been used to assess smoothness of movement.]
Timepoint [1] 290733 0
[Timepoint: At baseline, immediately after intervention [12 weeks] and at 24 weeks following baseline]
Primary outcome [2] 290734 0
[Primary outcome 2: Static postural stability will be assessed while participants are standing quietly for 30 seconds on a portable AMTI force plate. Measurements derived from the force plate data will include; 1) the range and standard deviations (SD) of the centre of pressure (COP) displacements in the anterior-posterior (AP) and medial-lateral (ML) directions; 2) sway area; and 3) sway velocity.]
Timepoint [2] 290734 0
[Timepoint: At baseline, immediately after intervention [12 weeks] and at 24 weeks following baseline]
Secondary outcome [1] 305111 0
[Secondary outcome 1: Muscle function as measured by surface electromyography]
Timepoint [1] 305111 0
[Timepoint: At baseline, immediately after intervention [12 weeks] and at 24 weeks following baseline]
Secondary outcome [2] 305112 0
[Secondary outcome 2: Symptom severity as measured by the Unified Parkinson’s Disease Rating Scale (UPDRS), freezing of gait questionnaire, Hoehn & Yahr scale and Schawb and England Activities of Daily living scale]
Timepoint [2] 305112 0
[Timepoint: : At baseline, immediately after intervention [12 weeks] and at 24 weeks following baseline]

Eligibility
Key inclusion criteria
[Individuals diagnosed with idiopathic Parkinson's disease (PD) based on the UK Brain Bank Criteria and who have a history of one fall or more in the previous 12 months will be eligible to participate]
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
[Participants will be excluded if they; i) are unable to stand and walk independently without the use of a walking aid, ii) have any significant visual (Bailey-Lovie high contrast visual acuity > 0.30 logMAR) or cognitive impairment (Addenbrooke’s cognition examination score <82); iii) have uncontrolled hypertension; iv) are taking psychotropic medications; v) have any significant limitations due to osteoporosis; vi) have had any orthopaedic surgery within the previous year; vii) have any serious neck, shoulder or back injuries; including spinal fusions; or viii) have received deep brain stimulation surgery to manage their symptoms.]

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)
[Prospective participants will be sent an invitation to participate in the study, which will include information about the risks and benefits of the study, the nature of the assessments and the time commitment involved for volunteers. Individuals who provide consent to participate in this study will be asked to attend an initial session to allow a series of baseline assessments of cognition, symptom severity, balance and gait to be performed. Following the baseline assessments, participants will be assigned to one of two intervention groups; i) education (placebo); ii) exercise once per week. The assignment of participants to one of these groups will be determined using the permuted block randomisation method following their recruitment into the study. To minimise the risk of biasing the sample, the randomisation process will be completed by a member of the research team who will have no direct involvement in the recruitment or assessment of the research participants.]
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
[Population Estimation: Based on the results of a statistical power calculation, it was determined that a minimum of 11 participants per group is needed to confidently report any significant changes in standing and walking stability (Power = 80%, p = 0.05). Given the longitudinal nature of the research, the recruitment of 15 individuals to each intervention group would accommodate a 25% attrition rate.]
[To assess for any significant differences between the groups with respect to the continuous demographic variables (e.g. age, height, weight,) a one way ANOVA will be used, while the Chi-square test will be sued to identify any significant differences in the frequency of categorical data (e.g. gender, Hoehn & Yahr scale). If a significant difference is found, the Tukey’s honestly significant difference test will be used to perform post-hoc comparisons between groups. If the assumptions of normality (Shapiro-Wilks test) and homogeneity of variance (Levene’s test) of the ANOVA are violated, the non-parametric Kruskal-Wallis test will be used. Analysis of the outcome measures for static and dynamic postural stability will be based on an intention to treat. To assess acute (12weeks) and long-term (24 weeks) effects of the intervention on measures of postural stability, a repeated measures analysis of covariance (RM_ANCOVA) will be conducted, with the baseline value for each outcome measure and disease severity entered as covariates. To determine covariates, variables of age and disease severity will be graphed in relation to baseline measures of postural stability to identify any linear relationships.]

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/01/2014
Actual
10/03/2014
Date of last participant enrolment
Anticipated
1/10/2015
Actual
5/06/2015
Date of last data collection
Anticipated
Actual
17/12/2015
Sample size
Target
45
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 288146 0
University
Name [1] 288146 0
The Australian Catholic University
Country [1] 288146 0
Australia
Primary sponsor type
Individual
Name
Dr. Michael Cole
Address
Michael Cole
Australian Catholic University
PO Box 456
Virginia QLD, 4014
Country
Australia
Secondary sponsor category [1] 286863 0
Individual
Name [1] 286863 0
Ryan Hubble
Address [1] 286863 0
Ryan Hubble
Australian Catholic University
PO Box 456
Virginia QLD, 4014
Country [1] 286863 0
Australia
Other collaborator category [1] 277661 0
Individual
Name [1] 277661 0
Professor Geraldine Naughton
Address [1] 277661 0
Professor Geraldine Naughton
Australian Catholic University
Locked Bag 4115
Fitzroy MDC
Fitzroy Victoria 3065
Country [1] 277661 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290063 0
The Australian Catholic Univeristy Human Research Ethics Committee
Ethics committee address [1] 290063 0
Ethics committee country [1] 290063 0
Australia
Date submitted for ethics approval [1] 290063 0
Approval date [1] 290063 0
30/09/2013
Ethics approval number [1] 290063 0
2013 223Q

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

Contacts
Principal investigator
Name 43706 0
Dr Michael Cole
Address 43706 0
Dr. Michael Cole
Australian Catholic University
PO Box 456
Virginia Queensland 4014
Country 43706 0
Australia
Phone 43706 0
+61 7 36237674
Fax 43706 0
Email 43706 0
[email protected]
Contact person for public queries
Name 43707 0
Michael Cole
Address 43707 0
Dr. Michael Cole
Australian Catholic University
PO Box 456
Virginia Queensland 4014
Country 43707 0
Australia
Phone 43707 0
+61 7 36237674
Fax 43707 0
Email 43707 0
[email protected]
Contact person for scientific queries
Name 43708 0
Ryan Hubble
Address 43708 0
Ryan Hubble
Australian Catholic University
PO Box 456
Virginia Queensland 4014
Country 43708 0
Australia
Phone 43708 0
+61 7 36237703
Fax 43708 0
Email 43708 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
SourceTitleYear of PublicationDOI
EmbaseTrunk Exercises Improve Balance in Parkinson Disease: A Phase II Randomized Controlled Trial.2019https://dx.doi.org/10.1097/NPT.0000000000000258
N.B. These documents automatically identified may not have been verified by the study sponsor.