Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001279910p
Ethics application status
Not yet submitted
Date submitted
22/10/2020
Date registered
26/11/2020
Date last updated
26/11/2020
Date data sharing statement initially provided
26/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the safety, satisfaction and efficacy of pulmonary tele rehabilitation for people with respiratory conditions, including patients recovering from COVID-19.
Scientific title
Impact of pulmonary tele rehabilitation on exercise capacity and health-related quality of life in people with respiratory conditions, including patients recovering from COVID-19.
Secondary ID [1] 302591 0
nil
Universal Trial Number (UTN)
U1111-1259-9240
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory conditions 319471 0
Asthma 319646 0
Bronchiectasis 319647 0
COPD 319648 0
COVID-19 319649 0
Lung Cancer 319650 0
Interstitial Lung Disease 319651 0
Condition category
Condition code
Respiratory 317438 317438 0 0
Chronic obstructive pulmonary disease
Respiratory 317582 317582 0 0
Asthma
Cancer 317583 317583 0 0
Lung - Non small cell
Cancer 317672 317672 0 0
Lung - Mesothelioma

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Tele rehabilitation exercise training for patients with respiratory conditions

All people who were referred to RPAH pulmonary rehab program were invited to attend the pulmonary tele rehabiltiation program even if they did not wish to participate in the study. Face to face pulmonary rehabilitation was suspended due to COVID-19. When face to face pulmonary rehabilitation returns, the tele rehabilitation program will remain as an option for patients who wish to exercise at home and who have technology. This study is a program review of routinely collected data

Assessment: Full initial assessment was conducted via tele rehabilitation in a one to one session (40 minutes via zoom platform). Additional participant history was also extracted from SLHD electronic medical records (eMR). The initial assessment included medical history, collection of outcome measures (see below) and goal setting. The initial assessment allowed the main problems and comorbidities to be screened so the exercises could be individually tailored within the group class. The participant’s environment (including chair) was assessed for safety. It was not possible to collect data on six-minute walk distance, resting and end exercise oxygen saturation and heart rate via tele health. Final assessment (40 minutes via zoom platform) collected the same outcome measures as the initial assessment plus patients were asked to complete a satisfaction survey

Exercise training: Participants then commenced the tele rehabilitation exercise training. Number of participants in each telerehab session ranged from one to ten.
>Intensity: participants were asked work to a level of 3 to 4 on the modified BORG scale of dyspnoea.
>Frequency/duration: participants could attend exercise training twice per week for eight weeks. Each class lasted 40 minutes. Seven classes were held each week with two slower paced groups for people using LTOT.
>Monitoring: Close monitoring with instructions given by a physiotherapists sitting near the screen and another demonstrating the exercises so participants could easily follow
>Attendance: an exercise checklist was marked for each exercise performed and each visit attended.

The exercise training classes consisted of:
>Warm up stretches that consisted of arm, leg and thoracic mobilisation
>Strength training that consisted of sit to stand, squats, heel raises and arm weights (using available equipment e.g. water bottles and tin cans) and theraband if available
>Aerobic training that consisted of marching on the spot, high knee walking, jogging and side stepping
>Seated rests were interspersed with the exercise to allow breathless management and short recovery periods

The education sessions were run weekly for 4 weeks with each session lasting 30 minutes. They were informal with questions and answers. The education topics focused on the management of breathlessness, exacerbations of the participant’s condition and COVID-19 concerns. Participants were asked to call the office if they had personal questions to ask or needed more information.

Participants were reassessed via tele health after 16 sessions of tele rehab exercise training

Data: will be collected retrospectively and prospectively - starting March 2020 when face to face pulmonary rehabiltiation was suspended. People will continue to choose to attend pulmonary tele rehabiltiation and so data collection will continue until early to middle 2021.
Intervention code [1] 318872 0
Diagnosis / Prognosis
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325475 0
Exercise capacity (strength) using five sit to stand test (5STS) on all participants
Timepoint [1] 325475 0
Baseline (pre intervention) and 8 weeks (post intervention) on all participants
Primary outcome [2] 325476 0
Health related quality of life using the St George's Respiratory Questionnaire and COPD Assessment tool on all participants
Timepoint [2] 325476 0
Baseline (pre intervention) and 8 weeks (post intervention) on all participants
Secondary outcome [1] 388070 0
Exercise capacity (endurance) using the one minute sit to stand (1min STS) on all participants
Timepoint [1] 388070 0
Baseline (pre intervention) and 8 weeks (post intervention) on all participants
Secondary outcome [2] 388071 0
Anxiety and Depression using the Hospital Anxiety and Depression Scale (HADS) on all participants
Timepoint [2] 388071 0
Baseline (pre intervention) and 8 weeks (post intervention) on all participants
Secondary outcome [3] 388613 0
Satisfaction using a survey designed especialy for this study on all participants
Timepoint [3] 388613 0
At final assessment - 8 weeks only on all participants
Secondary outcome [4] 388620 0
Adverse events inluding pain, dizziness, falls and hospital admissions will be recorded. Data will be collected from data linkage to the hospital medical record and from the participants via telephone survey.
Timepoint [4] 388620 0
Baseline, throughout the program and at the 8 weeks final assessment.
Secondary outcome [5] 388899 0
Hospital admissions for the previous 12 months will also be collected from data linkage to the hospital medical record and from the participants via telephone survey.
Timepoint [5] 388899 0
Baseline only.

Eligibility
Key inclusion criteria
People with underlying respiratory condition (COPD, Bronchiectasis, ILD, Asthma, Lung Ca), following lung surgery or people recovering from COVID-19 and those using long term oxygen therapy (LTOT)
People with access to WIFI and a home device (tablet, computer or mobile phone)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People not interested in participating in pulmonary rehabilitation
People with no access to technology

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Initial and final data for all outcome measures will be collected at baseline and completion of the program. All data will be stored on an excel file on a password protected computer in a locked office. Data for a within group difference will be analysed using SPSS.
As the study is a program review all patients will be included and therefore no power calcualtion was deemed necessary

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 31712 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 307019 0
Hospital
Name [1] 307019 0
Royal Prince Alfred Hospital
Country [1] 307019 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Physiotherapy Department
57 Missenden Rd
Camperdown
2050 NSW
Country
Australia
Secondary sponsor category [1] 307589 0
None
Name [1] 307589 0
Address [1] 307589 0
Country [1] 307589 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 307150 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 307150 0
Ethics committee country [1] 307150 0
Australia
Date submitted for ethics approval [1] 307150 0
19/12/2020
Approval date [1] 307150 0
Ethics approval number [1] 307150 0

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

Contacts
Principal investigator
Name 106206 0
A/Prof Lissa Spencer
Address 106206 0
Physiotherapy Department
Royal Prince Alfred Hospital
Missenden Rd, Camperdown 2050 NSW
Country 106206 0
Australia
Phone 106206 0
+61 2 95159857
Fax 106206 0
+61 2 95159751
Email 106206 0
lissa.spencer@health.nsw.gov.au
Contact person for public queries
Name 106207 0
Lissa Spencer
Address 106207 0
Physiotherapy Department
Royal Prince Alfred Hospital
Missenden Rd, Camperdown 2050 NSW
Country 106207 0
Australia
Phone 106207 0
+61 2 95159857
Fax 106207 0
+61 2 95159751
Email 106207 0
lissa.spencer@health.nsw.gov.au
Contact person for scientific queries
Name 106208 0
Lissa Spencer
Address 106208 0
Physiotherapy Department
Royal Prince Alfred Hospital
Missenden Rd, Camperdown 2050 NSW
Country 106208 0
Australia
Phone 106208 0
+61 2 95159857
Fax 106208 0
+61 2 95159751
Email 106208 0
lissa.spencer@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.