Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001263886
Ethics application status
Approved
Date submitted
15/11/2012
Date registered
3/12/2012
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Telerehabilitation in people with Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
The effect of telerehabilitation on exercise capacity, physical activity and quality of life in people with Chronic Obstructive Pulmonary Disease (COPD): A randomised controlled trial.
Secondary ID [1] 281489 0
None
Universal Trial Number (UTN)
U1111-1136-6346
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 287755 0
Condition category
Condition code
Respiratory 288095 288095 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 288096 288096 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Telerehabilitation Group (TG) Training Program:
Written instructions will be provided reinforcing the requirements for the exercise training sessions. In the TG group, training will run for a total of eight weeks, twice a week for one hour. The session will include aerobic exercises utilising cycle ergometry and walking training. The initial intensity, duration and frequency of the participant’s exercise program will be prescribed by the assessor (RM) following the initial assessments. The primary researcher (LLT) will be conducting all TG training sessions. During the hourly training session participants will be asked to perform a total of 30 minutes of aerobic training including 15 minutes on the cycle ergometer and 15 minutes walking. Participants will be monitored via collection of oxygen saturation (SpO2), Heart Rate, Borg Dyspnoea Score and Rate of Perceived Exertion (RPE) at the start of the sessions, seven minutes into cycle ergometer training session and seven minutes into the walking training session as well as at the end of each session. Oxygen saturation (SpO2) and heart rate will be monitored by using the finger tip oximeter provided to participants. Exercise intensity, duration and frequency will be progressed and recorded during the eight weeks of TG training according to the Borg Dyspnoea Score and Rate of Perceived Exertion (RPE) readings obtained during the sessions in order to maintain a Borg Dyspnoea Score of Moderate to Somewhat Severe (Score 3-4) and Rate of Perceived Exertion of Moderate to Somewhat Severe (Score 12-13).
The primary researcher (LLT) will remain in contact with the participants for the duration of the trial and will be responsible for trouble-shooting any problems as they arise. A physiotherapist will only be visiting participants before the first session of the project to set up the cycle ergometer and laptop computer and at the end of the eight week training period to collect the cycle ergometer and laptop computer. Participants will be instructed clearly that physiotherapists will not be doing home visits unless there is a technical issue that cannot be resolved over the phone or during the videoconferencing session. The number of participants receiving the Telerehabilitation at the same time will range from 2 to 4 participants.

All the participants randomized to the telerehabilitation group will receive a Telerehabilitation Education Booklet with information on all the technology they need to know how to use as well as information on the exercise program. In order to deliver telerehabilitation the following will be required:
A laptop computer provides a screen for the participants to be able to see the physiotherapist in order for their exercise program to be supervised. Each laptop computer will be installed with videoconferencing software and an internet connection will be provided. The computer to be used in this study will be the “hp EliteBook 8560p” which is provided by NSW Health South Eastern Sydney Local Health District. The laptop computer has an inbuilt camera; the angle of which can be easily adjusted by moving the screen. Participants in the Telerehabilitation group (TG) will be educated about how to use this computer to ensure they can operate the device independently. This will include understanding how to turn the computer on/off and how to charge the computer device.
A wireless audio headset “Logitech ClearChat PC Wireless” headset which participants will wear during the telerehabilitation sessions. This ensures participants will be able to hear and talk to the physiotherapists easily. Participants will be trained on how to charge the device and how to operate the headset with training and demonstration.
A pre-paid internet connection will be provided to participants (wireless Telstra 4G USB modem device) that can be plugged into the laptop. 4G device from Telstra has been purchased as it is ten times faster than 3G with fast download speed.
Videoconferencing software Vsee (www.vsee.com) which will be installed on the computer provided to participants and will be used during the TG training sessions. This software has been shown to be secure and safe (please visit http://vsee.com/hipaa for security information). The Director of Operations at the Prince of Wales Hospital Mr Andrew Bernard has also approved this software to be installed to the computer laptops. Participants will be reminded to log onto Vsee 15 minutes prior to the commencement of the TG training sessions to ensure the exercise class starts at the given time. Participants will be notified during the first assessment day of the time of the telerehabilitation exercise training. The participant will also be reminded of the start date and time of telerehabilitation exercise training during delivery of the equipment.
During the telerehabilitation session participants will exercise on a stationary cycle ergometer (Tunturi E60 cycle ergometer). The cycle ergometer will be adjusted so that the seat height and the foot straps are correct for each participant. The physiotherapist will demonstrate to the participants how to use the cycle ergoemeter.

Finger tip pulse oximeter:
Oxygen saturation and heart rate will be measured during TG training sessions using a pulse oximeter (Nonin-9590). It is easily operated by the participant placing a “clip” probe onto their index finger.

Patient instruction on home training:
Participants will receive two one hour Telerehabiliation exercise sessions supervised remotely by the experienced physiotherapist, twice a week either Monday and Wednesday or Tuesday and Thursday for eight weeks. Participants will be asked to participate in independent walking training for a total of half an hour a day at least one day a week in addition to the telerehabilitation exercise sessions.
Intervention code [1] 285999 0
Rehabilitation
Intervention code [2] 286147 0
Treatment: Other
Comparator / control treatment
No Rehabilitation (NR) Group:
The NG will receive usual medical care consisting of physician advice, prescribed pharmaceutical therapy and home-based community nursing follow ups as indicated. This group will be asked not to perform any exercise training for 8 weeks and will not be given instructions regarding exercise. The majority of people with COPD who are referred or self-referred to pulmonary rehabilitation are sedentary and are unlikely to be engaged in a formal exercise program. If participants are already involved in any type of exercise, this will not be ceased, but the pulmonary rehabilitation coordinator (RM) will record how much exercise they are currently doing by asking the participants at the first face to face assessment visit. As part of standard medical care, participants are referred to pulmonary rehabilitation; however, the normal waiting list time for pulmonary rehabilitation is approximately two to three months. Therefore, we are not withholding usual medical care and participants will be guaranteed a place to attend pulmonary rehabilitation at the end of the study period. NG group will have the same assessment completed as per page 4 measuring all outcome measures.
Control group
Active

Outcomes
Primary outcome [1] 288300 0
Endurance Exercise Capacity: The Endurance Shuttle Walk Test (ESWT) will be used to measure endurance exercise capacity. The ESWT will be performed on a 10 metre track at a velocity equivalent to 85% of the participants peak velocity achieved on the incremental shuttle walk test (ISWT) until voluntary task failure or 20 minutes is reached. Two tests will be performed and the data from the best test used in analysis.
Timepoint [1] 288300 0
Baseline and eight weeks post intervention
Secondary outcome [1] 299783 0
Peak Exercise Capacity: The Incremental Shuttle Walk Test (ISWT) will be performed on a 10 metre track to measure peak exercise capacity. This test is externally paced with work rate (i.e. velocity) increasing each minute. Two tests will be performed and the data from the best test used in analysis.
Timepoint [1] 299783 0
Baseline and eight weeks post intervention
Secondary outcome [2] 299784 0
Functional Exercise Capacity: The Six minute Walk Test (6MWT) will be used to measure functional exercise capacity. This is a self-paced walking test on a 30 metre track. Two tests will be performed and the data from the best test used in analysis.
Timepoint [2] 299784 0
Baseline and eight weeks post intervention
Secondary outcome [3] 299949 0
Physical Activity Level (Objective): The SenseWear (Model MF) Armband will be used to measure energy expenditure and step count.

*Please note there is MF is the model not the abbreviation.
Timepoint [3] 299949 0
baseline and eight weeks post intevention. Armband will be worn for 7 days to collect data.
Secondary outcome [4] 299950 0
Physical Activity Level (Subjective): The Functional Performance Inventory - Short Form (FPI-SF) is a self-administered questionnaire designed to evaluate functional performance in people with COPD.
Timepoint [4] 299950 0
Baseline and eight weeks post intevention
Secondary outcome [5] 299951 0
Quality of Life: The Chronic Respiratory Disease Questionnaire (CRDQ) will be used to measure dyspnoea, fatigue, emotional function and mastery
Timepoint [5] 299951 0
Baseline and eight weeks post intervention
Secondary outcome [6] 299952 0
Dyspnoea: The Modified Medical Research Council dyspnoea scale (MMRC) will be used.
Timepoint [6] 299952 0
Baseline and eight weeks post intervention
Secondary outcome [7] 299953 0
Anxiety and Depression: The Hospital anxiety and depression scale (HADS) will be used. There is evidence that people with COPD have a high level of anxiety and depression and HADS has been shown to be a valid outcome measurement tool in this population (Dawson, 2001).
Timepoint [7] 299953 0
Baseline and eight weeks post intervention
Secondary outcome [8] 299954 0
COPD health status: The COPD Assessment TestTM (CAT) will be used to measure this.
Timepoint [8] 299954 0
Baseline and eight weeks post intervention
Secondary outcome [9] 299955 0
Self efficacy: The Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) is the tool that will be used to measure the effect of telerehabilitation on self-efficacy.
Timepoint [9] 299955 0
Basline and eight weeks post intervention
Secondary outcome [10] 299956 0
Patient satisfaction: The Client Satisfaction Questionnaire 8 (CSQ-8) will be adapted to determine the level of satisfaction in the telerehabilitation group to the intervention.
Timepoint [10] 299956 0
eight weeks post intervention in telerehabilitation group only
Secondary outcome [11] 310620 0
A semi-structured interview will also be conducted in an interactive manner with participants who completed the telerehabilitation intervention. This interview will take place up to two months following completion of the telerehabilitation program. We intend to involve a random selection of at least 12 participants in this process who will be selected by an independent physiotherapist. The purpose of the semi-structured interview is to assess the quality of the Telerehabiltiation service delivery which allows participants to tell their story in a non-biased manner. It will be conducted by Co-Investigator Mrs Chloe Moddel who will ask you ten questions regarding your satisfaction with the Telerehabilitation service and whether you found it effective. The semi-structured interview will be conducted for approximately 60 minutes will also be digitally recorded.
Timepoint [11] 310620 0
Two months after the completion of 8 weeks Telerehabilitation program
Secondary outcome [12] 310621 0
Telerehabilitation participant survey. This survey is designed to ask participants about their opinions and attitudes towards telerehabilitation to help identify any facilitators or barriers to compliance with this service. This survey is not validated but it is specifically designed for this study.
Timepoint [12] 310621 0
At the end of eight weeks of telerehabilitation program, on the last day of final assessment
Secondary outcome [13] 310622 0
The name of the survey is "Occupant Survey on Telerehabilitation" which is specially designed for this study. This survey is designed to investigate the participants' family/friends/residence who lives with them their opinion on this service due to telerehabilitation program is conducted at partcipant's home and their family/friends/residence could be invovled in the telerehabilitation program.
Timepoint [13] 310622 0
This is an optional survey that is conducted at the completion of the eight weeks telerehabilitation program.

Eligibility
Key inclusion criteria
Diagnosis: Stable COPD(FEV1/FVC <70% and FEV1 < 80% predicted and post bronchodilator).
Sex: Both Females and Males.
Age range: > 35 years old with no upper limit.
Weight: Less than 150 kgs.
Participants who have not participated in any exercise program for 12 months.
Participants who have not been admitted to hospital for an acute exacerbation of COPD in the last 2 months.
Current or ex-smoker.
Ability to operate a laptop computer , audio headset and the internet at home independently after training.
Adequate hearing, able to hear sounds clearly from a computer laptop.
Adequate eye sight, able to see the computer screen clearly.
Agrees to have a stationary exercise bike placed in their home during the intervention period.
Able to mobilise independently with or without a walking aid.
Able to get on and off a stationary exercise bike. independently and safely.
Willingness to participate.
Willingness to give written informed consent.
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive Impairment (Mini Mental State Exam score < 24).
Unstable cardiac or neurological disease.
Unable to participate due to any musculoskeletal conditions.
Inability to consent or understand English.
Eyesight impairment that could inhibit reading from a laptop computer screen.
Hearing impairment that could inhibit listening through an audio headset.
Inability to operate a laptop computer following instructions and/or after a period of training.
Unwillingness to accept the technology and set up of devices and exercise equipment in their home environment.
Weight > 150kgs.
Unable to be contacted via a telephone and/or mobile phone device.

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)
All participants referred to pulmonary rehabilitation at POWH will be screened by the pulmonary rehabilitation coordinator and recruited according to the inclusion and exclusion criteria (on the previous page). Participants will be randomly allocated to the intervention group or the control group using a central randomisation process by phone organised by the NHMRC clinical trials centre (i.e. external to investigators with concealed allocation).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic random allocation will be used with minimisation for lung function (FEV1 % predicted >50%) and six minute walk distance (6MWD >350 m).

Randomisation will be computer-generated and conducted by the NHMRC clinical trials centre (i.e. external to investigators with concealed allocation).
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
28/01/2013
Actual
24/03/2014
Date of last participant enrolment
Anticipated
Actual
1/06/2016
Date of last data collection
Anticipated
Actual
1/09/2016
Sample size
Target
42
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286288 0
Government body
Name [1] 286288 0
NSW Health South Eastern Sydney Local Health District Chronic Care Redesign Grant 2012
Country [1] 286288 0
Australia
Funding source category [2] 289994 0
Government body
Name [2] 289994 0
NSW Agency for Clinical Innovation
Country [2] 289994 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
Physiotherapy Department, Level 1, High Street, Randwick, NSW, 2031
Country
Australia
Secondary sponsor category [1] 285061 0
University
Name [1] 285061 0
The University of Sydney
Address [1] 285061 0
FACULTY OF HEALTH SCIENCES
Cumberland Campus, The University of Sydney, NSW, 1825
Country [1] 285061 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288337 0
South Eastern Sydney Local Health District
Ethics committee address [1] 288337 0
Ethics committee country [1] 288337 0
Australia
Date submitted for ethics approval [1] 288337 0
03/09/2012
Approval date [1] 288337 0
20/03/2014
Ethics approval number [1] 288337 0
1/12/0177

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

Contacts
Principal investigator
Name 34912 0
Ms Ling Ling Tsai
Address 34912 0
Prince of Wales Hospital, Physiotherapy Department, Level 1, High street, Randwick, NSW, 2031
Country 34912 0
Australia
Phone 34912 0
+61410586987
Fax 34912 0
Email 34912 0
[email protected]
Contact person for public queries
Name 18159 0
Ling Ling Tsai
Address 18159 0
Prince of Wales Hospital, Physiotherapy Department, Level 1, High street, Randwick, NSW, 2031
Country 18159 0
Australia
Phone 18159 0
61293822671
Fax 18159 0
61293822868
Email 18159 0
[email protected]
Contact person for scientific queries
Name 9087 0
Ling Ling Tsai
Address 9087 0
Prince of Wales Hospital, Physiotherapy Department, Level 1, High street, Randwick, NSW, 2031
Country 9087 0
Australia
Phone 9087 0
61293822671
Fax 9087 0
61293822868
Email 9087 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
SourceTitleYear of PublicationDOI
EmbaseHome-based telerehabilitation via real-time videoconferencing improves endurance exercise capacity in patients with COPD: The randomized controlled TeleR Study.2017https://dx.doi.org/10.1111/resp.12966
N.B. These documents automatically identified may not have been verified by the study sponsor.