Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000579099
Ethics application status
Approved
Date submitted
16/07/2010
Date registered
19/07/2010
Date last updated
5/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Control Trial of the Effectiveness of Exercise Augmentation in Patients with Post Traumatic Stress Disorder
Scientific title
In people with primary Post Traumatic Stress Disorder (PTSD) what is the effect of exercise in addition to usual care, on PTSD symptoms and physical parameters compared to usual care only: A Randomised Control Trial.
Secondary ID [1] 252217 0
Nil
Universal Trial Number (UTN)
Trial acronym
REAPP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Traumatic Stress Disorder 257590 0
Condition category
Condition code
Mental Health 257764 257764 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the intervention group will complete a 12 week individualised exercise program based around the Randomised Exercise Augmentation for PTSD Patients (REAPP) exercises, involving exercise bands and body weight as resistance. Participants will have one supervised session of approximately 30 minutes duration per week and will be asked to complete an additional two unsupervised sessions per week of approximately the same duration. Exercises are mostly compound, and focus on the major muscle groups. A walking component will also be included within the intervention. All sessions will be held at St John of God Healthcare's Richmond Hospital and will be supervised by an Exercise Physiologist or a nurse trained in delivering the exercise program.
Motivational interviewing, goal setting and exercise diaries will be used in order to facilitate adherence and encourage adoption of the intervention program.
Intervention code [1] 256766 0
Treatment: Other
Comparator / control treatment
Usual care, which involves a combination of psychotherapy, pharmaceutical interventions and group therapy facilitated by psychologists.
Control group
Active

Outcomes
Primary outcome [1] 258441 0
PTSD symptoms: Post Traumatic Stress Disorder- Checklist Civilian (PCL-C)
Timepoint [1] 258441 0
pre and post 12 week intervention period
Primary outcome [2] 258704 0
psychological symptoms: Depression, Anxiety, Stress Scale (DASS)
Timepoint [2] 258704 0
pre and post 12 week intervention period
Secondary outcome [1] 264224 0
Pro re nata (PRN) medication usage (self-report questionnaire)
Timepoint [1] 264224 0
pre and post 12 week intervention period.
Intervention group will be assessed weekly throughout the 12 week period.
Secondary outcome [2] 264225 0
Sleep behavior: Pittsburgh Sleep Quality Index (PSQI)
Timepoint [2] 264225 0
pre and post 12 week intervention period
Secondary outcome [3] 264227 0
anthropometry (Body Mass Index, waist circumference, blood pressure, weight, body fat %)
Obtained through standard measuring procedures with tape measures, bio-impedence scales and sphygmomanometers
Timepoint [3] 264227 0
pre and post 12 week intervention period
Secondary outcome [4] 264228 0
physical activity participation: International Physical Activity Questionnaire (IPAQ) short form (self-report questionnaire)
Timepoint [4] 264228 0
pre and post 12 week intervention period
Secondary outcome [5] 264604 0
short form physical performance battery (physical measures)
Timepoint [5] 264604 0
pre and post 12 week intervention period
Secondary outcome [6] 264605 0
hand grip strength with a dynamometer (physical measure)
Timepoint [6] 264605 0
pre and post 12 week intervention period
Secondary outcome [7] 264606 0
lower limb strength (spring balance) (physical measure)
Timepoint [7] 264606 0
pre and post 12 week intervention period
Secondary outcome [8] 264607 0
Six-minute walk test (physical measure)
Timepoint [8] 264607 0
pre and post 12 week intervention period
Secondary outcome [9] 264608 0
Single-leg stance time (physical measure)
Timepoint [9] 264608 0
pre and post 12 week intervention period

Eligibility
Key inclusion criteria
Diagnositc and Statistical Manual of Mental Disorders-IV (DSM)diagnosis of PTSD
Medically fit to participate in an exercise program
Physically capable of exercising
Competent to consent to participate in research as determined by medical staff
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medically unfit to participate in an exercise program
Pregnant or planning pregnancy within the next year.
Complex PTSD with trauma occurring in childhood only.

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)
The research psychiatrist/medical officer/exercise physiologist screens for inclusion criteria. If the person satisfies criteria the study psychiatrist/medical officer completes baseline assessment then contacts the external investigator who will determine group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be determined using a computer generated random number schedule with randomly permuted block sizes. The schedule will be developed by an external investigator who will not be directly involved in participant recruitment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/10/2010
Actual
15/10/2010
Date of last participant enrolment
Anticipated
Actual
1/05/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257151 0
Self funded/Unfunded
Name [1] 257151 0
Country [1] 257151 0
Primary sponsor type
Individual
Name
Dr Simon Rosenbaum
Address
Research Associate
University of New South Wales
Bondi Early Psychosis Programme
26 Llandaff St Bondi Junction
NSW 2022
Country
Australia
Other collaborator category [1] 251374 0
Individual
Name [1] 251374 0
Dr Cathie Sherrington
Address [1] 251374 0
The George Institute for Global Health,
PO Box M201
Missenden Road Sydney NSW 2050
Country [1] 251374 0
Australia
Other collaborator category [2] 251375 0
Individual
Name [2] 251375 0
Dr Anne Tiedemann
Address [2] 251375 0
The George Institute for Global Health,
PO Box M201
Missenden Road Sydney NSW 2050
Country [2] 251375 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259197 0
St John of God Health Care Ethics Committee
Ethics committee address [1] 259197 0
Ethics committee country [1] 259197 0
Australia
Date submitted for ethics approval [1] 259197 0
Approval date [1] 259197 0
17/02/2010
Ethics approval number [1] 259197 0

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

Contacts
Principal investigator
Name 31170 0
Dr Simon Rosenbaum
Address 31170 0
University of New South Wales
The Bondi Centre
26 Llandaff St
Bondi Junction
NSW 2022
Country 31170 0
Australia
Phone 31170 0
+61 2 9366 8669
Fax 31170 0
Email 31170 0
[email protected]
Contact person for public queries
Name 14417 0
Simon Rosenbaum
Address 14417 0
University of New South Wales
The Bondi Centre
26 Llandaff St
Bondi Junction
NSW 2022
Country 14417 0
Australia
Phone 14417 0
+61 2 9366 8669
Fax 14417 0
+61 2 4571 1552
Email 14417 0
[email protected]
Contact person for scientific queries
Name 5345 0
Simon Rosenbaum
Address 5345 0
University of New South Wales
The Bondi Centre
26 Llandaff St
Bondi Junction
NSW 2022
Country 5345 0
Australia
Phone 5345 0
+61 2 9366 8669
Fax 5345 0
+61 2 4571 1552
Email 5345 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.