We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02995681




Registration number
NCT02995681
Ethics application status
Date submitted
14/12/2016
Date registered
16/12/2016
Date last updated
16/12/2016

Titles & IDs
Public title
Balance Training for Fall Reduction in COPD
Scientific title
Randomized Controlled Trial of Balance Training for Fall Reduction in Individuals With COPD
Secondary ID [1] 0 0
16-018-WP
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Copd 0 0
Fall Patients 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Balance training
Other interventions - Pulmonary rehab

Experimental: Pulmonary rehab and balance training - The intervention group will receive standard pulmonary rehab plus additional balance training.

Active Comparator: Pulmonary rehab - The control group will receive pulmonary rehab only and a pulmonary rehab home program (walking and lower extremity resistance exercises) upon discharge from pulmonary. They will also receive the same monthly phone calls and three home visits at three, six and nine months to ensure proper technique and progression.


Other interventions: Balance training
Balance exercises will include: functional lower extremity training, gait training under challenging conditions and training to increase stability during changes in body positions.

Other interventions: Pulmonary rehab
Pulmonary rehab includes: supervised exercise (aerobic exercise, resistance exercise) disease-specific education, and psychological and social support.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of falls - Number of falls will be measured using monthly falls diaries
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Berg Balance Scale - Clinical measure of balance
Timepoint [1] 0 0
Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
Secondary outcome [2] 0 0
Balance Evaluation Systems Test (BESTest) - Clinical measure of balance
Timepoint [2] 0 0
Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
Secondary outcome [3] 0 0
Activities Specific Balance Confidence Scale - Balance confidence questionnaire
Timepoint [3] 0 0
Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
Secondary outcome [4] 0 0
30 Second Repeated Chair Stand Test - Functional lower body strength test
Timepoint [4] 0 0
Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 12 months
Secondary outcome [5] 0 0
European Quality of Life 5-Dimension Questionnaire (EQ-5D-5L) - Health status questionnaire
Timepoint [5] 0 0
Baseline (pre pulmonary rehab), 8 weeks (post pulmonary rehab), 6 months, 12 months

Eligibility
Key inclusion criteria
- a physician diagnosis of COPD based on GOLD criteria; a self-reported decline in
balance, a fall within the last two years or a recent near fall; and an ability to
provide written informed consent
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- severe cognitive impairment (dementia, neurological condition) an inability to
communicate because of language skills (aphasia, non-English speaking), or evidence of
a neurological or musculoskeletal condition that severely limits mobility and postural
control (e.g. cerebrovascular accident, Parkinson's Disease, amputation) and may
jeopardize their safety or influence their balance.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
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 in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Alfred Health - Melbourne
Recruitment hospital [3] 0 0
Western Health - Saint Albans
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
3021 - Saint Albans
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Nova Scotia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Portugal
State/province [5] 0 0
Aveiro
Country [6] 0 0
United Kingdom
State/province [6] 0 0
North Yorkshire

Funding & Sponsors
Primary sponsor type
Other
Name
West Park Healthcare Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of British Columbia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Dalhousie University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Alberta
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Ottawa
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Teesside University
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
University of Sydney
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
La Trobe University
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Aveiro University
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
University of Toronto
Address [9] 0 0
Country [9] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
People living with Chronic Obstructive Pulmonary Disease (COPD) have problems with their
balance and a high incidence of falls compared to those of a similar age. Pulmonary
rehabilitation is recommended for people with COPD, however, these training programs do not
typically include balance training or fall prevention strategies. In this study, patients
with COPD who report problems with their balance or have had a fall in the last two years
will be assigned to a treatment group (balance training plus pulmonary rehabilitation) or
control group (standard pulmonary rehabilitation). We will record the number of falls using
monthly diaries and evaluate patient's balance, strength, confidence and quality of life.
Trial website
https://clinicaltrials.gov/show/NCT02995681
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dina Brooks, PhD
Address 0 0
West Park Healthcare Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dina Brooks, PhD
Address 0 0
Country 0 0
Phone 0 0
416-978-1739
Fax 0 0
Email 0 0
dina.brooks@utoronto.ca
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02995681