Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000308190
Ethics application status
Approved
Date submitted
12/02/2019
Date registered
28/02/2019
Date last updated
10/08/2020
Date data sharing statement initially provided
28/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Aquatic rehabilitation in connective tissue related interstitial lung disease
Scientific title
The feasibility of aquatic rehabilitation in people with connective tissue related interstitial lung disease
Secondary ID [1] 296921 0
None
Universal Trial Number (UTN)
Trial acronym
ARIEL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Connective tissue disease related interstitial lung disease (CTD ILD) 310873 0
Condition category
Condition code
Respiratory 309591 309591 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Water based exercise rehabilitaiton
Participants will attend a water-based group exercise program for one hour, twice per week for eight weeks. Each session will be supervised by a senior clinician physiotherapist, experienced in delivering water-based rehabilitation to patients with multiple co-morbidities, and an experienced pulmonary rehabilitation clinician. The exercise training will be conducted in a 33-35ºC hydrotherapy pool. Exercise will consist of 20-30 minutes of lower limb endurance training (walking, jogging, cycling, kicking dependent on the capability of the individual) in addition to 15 minutes of upper and lower body strength training (using speed, turbulence, various depths, equipment).
Intervention code [1] 313236 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318550 0
Feasability - comprised of participation and acceptability .
The number of participants approached, the number who consent, the number of sessions attended and completion rate (defined as undertaking at least 70% of planned sessions) will be recorded to assess feasibility. The 'water exercise acceptability questionnaire' will be used to assess participants’ acceptability with the water environment and exercise sessions. This questionnaire was developed and published by McNamara et al. Acceptability of the aquatic environment for exercise training by people with chronic obstructive pulmonary disease with physical co morbidities: Additional results from a randomised controlled trial. Physiotherapy 101 (2015) 187–192.
Timepoint [1] 318550 0
immediately post intervention
Secondary outcome [1] 365358 0
Change in health related quality of life using the chronic respiratory disease questionnaire (CRQ)
Timepoint [1] 365358 0
Baseline and immediately post intervention
Secondary outcome [2] 365359 0
Change in Dyspnea related disability - measured with modified medical research council scale (MMRC
Timepoint [2] 365359 0
Baseline and immediately post intervention
Secondary outcome [3] 365360 0
Change in fatigue using the FACIT fatigue scale
Timepoint [3] 365360 0
Baseline and immediately post intervention
Secondary outcome [4] 365361 0
Change in pain using the Brief Pain Inventory (BPI)
Timepoint [4] 365361 0
Baseline and immediately post intervention
Secondary outcome [5] 365362 0
Change in functional exercise capacity assessed by 6-minute walk distance
Timepoint [5] 365362 0
Baseline and immediately post intervention

Eligibility
Key inclusion criteria
- Diagnosis of mild-moderate connective tissue disease related interstitial lung disease (CTD-ILD)
- Dyspnoea on exertion despite maximal appropriate medical treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Severe CTD-ILD (FVC less than or equal to 50% predicted and/or TLCO less than 30% predicted).
- Severe pulmonary hypertension (WHO functional class IV)
- a history of syncope/pre-syncope on exertion
- resting hypoxaemia (SpO2 less than 88%) or resting dyspnoea.
- Inability to participate in aquatic rehabilitation e.g., acute/unstable cardiac disease, or fear of water.

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not Applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcomes of feasibility will be reported descriptively as numbers and percentages. Paired t tests or Wilcoxon signed-rank test will be used to evaluate the within group changes in symptoms, HRQoL, functional exercise capacity and strength following the water-based rehabilitation program. Statistical significance will be set at p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/06/2018
Date of last participant enrolment
Anticipated
31/03/2019
Actual
16/04/2019
Date of last data collection
Anticipated
31/05/2019
Actual
1/07/2019
Sample size
Target
24
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12815 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 12816 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 25285 0
3084 - Heidelberg
Recruitment postcode(s) [2] 25286 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 301491 0
Charities/Societies/Foundations
Name [1] 301491 0
Institute of Breathing and Sleep
Country [1] 301491 0
Australia
Funding source category [2] 301933 0
Charities/Societies/Foundations
Name [2] 301933 0
Austin Health Medical Research Foundation
Country [2] 301933 0
Australia
Primary sponsor type
Individual
Name
Dr Catherine Hill
Address
Physiotherapy Department
Austin Health
PO Box 5555 Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 301236 0
None
Name [1] 301236 0
Address [1] 301236 0
Country [1] 301236 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302235 0
Austin Hospital Ethics Committee
Ethics committee address [1] 302235 0
Ethics committee country [1] 302235 0
Australia
Date submitted for ethics approval [1] 302235 0
28/02/2018
Approval date [1] 302235 0
29/03/2018
Ethics approval number [1] 302235 0
LNR/18/Austin/93

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

Contacts
Principal investigator
Name 89538 0
Dr Catherine Hill
Address 89538 0
Physiotherapy Department
Austin Health
PO Box 5555
Heidelberg VIC 3084
Country 89538 0
Australia
Phone 89538 0
+61 3 9496 6779
Fax 89538 0
Email 89538 0
[email protected]
Contact person for public queries
Name 89539 0
Leona Dowman
Address 89539 0
Physiotherapy Department
Austin Health
PO Box 5555
Heidelberg VIC 3084
Country 89539 0
Australia
Phone 89539 0
+61 3 9496 5036
Fax 89539 0
Email 89539 0
[email protected]
Contact person for scientific queries
Name 89540 0
Catherine Hill
Address 89540 0
Physiotherapy Department
Austin Health
PO Box 5555
Heidelberg VIC 3084
Country 89540 0
Australia
Phone 89540 0
+61 3 9496 6779
Fax 89540 0
Email 89540 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data for this study will collected and kept in re-identifiable (coded) information. The code can be accessed only by the Investigators. Group data only will be presented in conference papers or publications of this research. If an instance arises where availability of individual participant data is required, it will be made available in a deidentified form with oversight of the appropriate HREC.


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.