Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001306303
Ethics application status
Approved
Date submitted
30/08/2017
Date registered
12/09/2017
Date last updated
12/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The addition of a physical activity intervention within pulmonary rehabilitation on physical activity levels: a pilot study.
Scientific title
The addition of a physical activity intervention within pulmonary rehabilitation on physical activity levels: a pilot study.
Secondary ID [1] 292775 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Respiratory Disease 304574 0
Condition category
Condition code
Respiratory 303903 303903 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Materials: G-Sensor 3D tri-axial pedometers, Participant Physical Activity Diary. Sedentary Behaviour Questionnaire (SBQ). Participant Physical Activity Log Sheet.

Procedures:
Tasks for participants include:
- Complete consent form pre intervention
- Complete the Sedentary Behaviour Questionnaire pre and post intervention
- Wear the pedometer and fill out participant physical activity diary (record number of steps taken per day) for length of intervention (5 weeks).
- Attend standard pulmonary rehabilitation classes twice a week for 8 weeks. Classes will be run by senior respiratory physiotherapists. Each class will run for 60 mins and the participants will complete lower limb endurance exercises, lower limb strengthening exercises and upper limb strengthening exercises.

Mode of Delivery: Face to face on an individual basis between a senior respiratory physiotherapist and the participant. The intervention will run once a week for 5 weeks. Each session will run for approximately 10-15 mins. At these sessions the participant will have their steps per day for the last week recorded (from the pedometer). They will then receive some counselling on how to improve their physical activity and then a new goal will be set for the next week. The new goal will aim to be a 5-10% increase on last weeks average daily step count. However, the senior clinician will decide in concert with the participant a suitable goal for the upcoming week. The physiotherapist will record if the target is reached at the next session.

Location: The intervention will take place at the pulmonary rehabilitation gym of each hospital or community health centre across the Northern Sydney Local Health District.
Intervention code [1] 299007 0
Lifestyle
Intervention code [2] 299008 0
Behaviour
Intervention code [3] 299009 0
Rehabilitation
Comparator / control treatment
The control group will attend standard pulmonary rehabilitation classes twice a week for eight weeks. Classes will be run by Senior Respiratory Physiotherapists. Each class will run for 60 mins and the participants will complete lower limb endurance exercises, lower limb strengthening exercises and upper limb strengthening exercises. The participants in the control group will not receive a pedometer, complete any physical activity counselling or goal setting or receive a physical activity diary.
Control group
Active

Outcomes
Primary outcome [1] 303240 0
Change in physical activity levels measured via steps per day.
Timepoint [1] 303240 0
Initial assessment prior to intervention (baseline).
Final assessment at Day 35 post intervention (final).
Secondary outcome [1] 338335 0
Change in sedentary behaviour time as measured in minutes per day using the Sedentary Behaviour Questionnaire (SBQ).
Timepoint [1] 338335 0
Initial assessment prior to intervention (baseline).
Final assessment at Day 35 post intervention (final).

Eligibility
Key inclusion criteria
- Attending exercise rehabilitation
- Diagnosis of chronic respiratory disease
- Able to speak, read and write in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have cognitive impairment or who do not speak/read sufficient English to understand the sedentary behaviour questionnaire.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Estimation: A total of 62 participants will be enrolled to ensure that 49 participants complete the study (accounts for a 20% drop-out rate). Forty-nine participants will be sufficient to provide 80% power to detect as significant, at the (two-sided) 5% level, a minimum 1100 steps improvement in the mean daily PA levels (i.e. which is the minimum important difference for daily steps) following pulmonary rehabilitation, assuming a standard deviation of 2000 steps per day.
Statistical Analysis Plan: The effects of the PA intervention will be determined by calculating the mean differences within the group for all outcomes from pre to post intervention using a paired t test. Uncertainty about the size of the mean differences within groups will be quantified with 95% confidence intervals.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/10/2017
Actual
Date of last participant enrolment
Anticipated
2/10/2018
Actual
Date of last data collection
Anticipated
14/12/2018
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8910 0
Manly Hospital - Manly
Recruitment hospital [2] 8911 0
Mona Vale Hospital - Mona Vale
Recruitment hospital [3] 8912 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 8913 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [5] 8914 0
Ryde Hospital - Eastwood
Recruitment postcode(s) [1] 17281 0
2095 - Manly
Recruitment postcode(s) [2] 17282 0
2103 - Mona Vale
Recruitment postcode(s) [3] 17283 0
2065 - St Leonards
Recruitment postcode(s) [4] 17284 0
2077 - Hornsby
Recruitment postcode(s) [5] 17285 0
2122 - Eastwood

Funding & Sponsors
Funding source category [1] 297405 0
Hospital
Name [1] 297405 0
Chronic Disease Community Rehabilitation Service - Northern Sydney Local Health District - NSW Health
Country [1] 297405 0
Australia
Primary sponsor type
Hospital
Name
Chronic Disease Community Rehabilitation Service - Northern Sydney Local Health District - NSW Health
Address
The Lodge - Building 37,
Macquarie Hospital,
Cnr Twin and Badajoz Rds, North Ryde NSW 2113
Country
Australia
Secondary sponsor category [1] 296399 0
None
Name [1] 296399 0
Address [1] 296399 0
Country [1] 296399 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298510 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 298510 0
Ethics committee country [1] 298510 0
Australia
Date submitted for ethics approval [1] 298510 0
20/04/2017
Approval date [1] 298510 0
07/07/2017
Ethics approval number [1] 298510 0
LNR/17/HAWKE/173

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

Contacts
Principal investigator
Name 77306 0
Mr Alexander Alam
Address 77306 0
The Lodge - Building 37,
Macquarie Hospital,
Cnr Twin and Badajoz Rds, North Ryde NSW 2113
Country 77306 0
Australia
Phone 77306 0
+61 2 8877 4041
Fax 77306 0
+61 2 8877 5370
Email 77306 0
[email protected]
Contact person for public queries
Name 77307 0
Alexander Alam
Address 77307 0
The Lodge - Building 37,
Macquarie Hospital,
Cnr Twin and Badajoz Rds, North Ryde NSW 2113
Country 77307 0
Australia
Phone 77307 0
+61 2 8877 4041
Fax 77307 0
+61 2 8877 5370
Email 77307 0
[email protected]
Contact person for scientific queries
Name 77308 0
Alexander Alam
Address 77308 0
The Lodge - Building 37,
Macquarie Hospital,
Cnr Twin and Badajoz Rds, North Ryde NSW 2113
Country 77308 0
Australia
Phone 77308 0
+61 2 8877 4041
Fax 77308 0
+61 2 8877 5370
Email 77308 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.