Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000699460
Ethics application status
Approved
Date submitted
13/06/2025
Date registered
1/07/2025
Date last updated
1/07/2025
Date data sharing statement initially provided
1/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of an Innovative Pathway Through Cardiac Rehabilitation for Individuals with Postural Orthostatic Tachycardia Syndrome (POTS)
Scientific title
Feasibility, Effectiveness and Acceptability of a Tailored Rehabilitation Pathway through Cardiac Rehabilitation for Individuals with Postural Orthostatic Tachycardia Syndrome (POTS)
Secondary ID [1] 314628 0
Clinical Excellence Queensland - AH004024
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postural Orthostatic Tachycardia Syndrome 337784 0
Condition category
Condition code
Cardiovascular 334126 334126 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tailored POTS Rehabilitation Pathway
This study is a single-arm uncontrolled clinical trial including both quantitative and qualitative components. Rehabilitation will be completed in two phases. Phase one involves 12 weeks of supervised rehabilitation sessions. Two one-hour supervised sessions, separated by at least one day, will be completed either in person or virtually each week. In person rehabilitation sessions and assessments will be completed in the Jaghu Gym (Hayden Centre) or delivered out of the rural hospitals (Laidley, Esk, Gatton and Boonah) within the West Moreton HHS. Virtual rehabilitation sessions will be delivered in real-time via the Queensland Health Virtual Clinic. Supervised exercise sessions will completed in a small group (maximum 4 participants). Three in-person assessments will be completed across phase one (pre, mid and post). Rehabilitation exercises will be individualised based on subjective information gathered during the initial assessment completed pre-rehabilitation. Rehabilitation sessions will include a combination of aerobic and resistance exercises. Initial aerobic exercise modalities may include recumbent cycling, rowing and swimming. As tolerated, upright cycling, walking or the elliptical may be introduced, Strength or resistance exercises will focus on lower body and core strength. Exercises may be body weight or utilise a resistance band, Example strength exercise include: leg extension, leg curl, leg press, calf raises, chest press and row. Exercise prescription will be gradually progressed weekly throughout the program based on assessment results and participant feedback. Phase two involves a further 12 weeks of unsupervised exercise. Participants will be provided with a home exercise program to complete during these unsupervised exercise sessions. During each week of phase two, participants will be asked to undertake four sessions, with each session lasting up to one-hour. Session duration will be individualised based on the duration achieved during the final supervised exercise sessions. Two phone reviews will be completed across this 12 week period. Intervention adherence will be assessed through supervised session attendance and unsupervised session completion discussed at assessments and during phase two phone reviews. Rehabilitation sessions, assessments and follow up phone reviews will be completed by the principal investigator (Accredited Exercise Physiologist with >3 years of clinical experience in Cardiopulmonary rehabilitation).
Intervention code [1] 331255 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341796 0
Patient feasibility - the proportion of patients who complete the program
Timepoint [1] 341796 0
At the completion of the project
Primary outcome [2] 341797 0
Rehabilitation effectiveness - the proportion of patients who report improvements in POTS Symptom Severity
Timepoint [2] 341797 0
Week 0, Week 7, Week 13 and Week 26 of rehabilitation program
Primary outcome [3] 341798 0
Rehabilitation effectiveness - proportion of patients who demonstrate an improvement in exercise tolerance
Timepoint [3] 341798 0
Week 0, Week 7 and Week 13 of rehabilitation program
Secondary outcome [1] 449049 0
Patient feasibility - the proportion of sessions attended by patients who complete the program This is an additional primary outcome
Timepoint [1] 449049 0
At the completion of the project
Secondary outcome [2] 448721 0
Program feasibility - number of occasions of service per patient
Timepoint [2] 448721 0
Analysis to occur at the completion of the project
Secondary outcome [3] 449050 0
Rehabilitation effectiveness - the proportion of patients who report improvements in fatigue This is an additional primary outcome
Timepoint [3] 449050 0
Week 0, Week 7, Week 13 and Week 26 of rehabilitation program
Secondary outcome [4] 448720 0
Acceptability of tailored rehabilitation program by patients
Timepoint [4] 448720 0
interviews will be completed in the final 3 months of the project. Analyses will occur at the completion of all interviews.
Secondary outcome [5] 449051 0
Rehabilitation effectiveness - the proportion of patients who report improvements health-related quality of life This is an additional primary outcome
Timepoint [5] 449051 0
Week 0, Week 7, Week 13 and Week 26 of rehabilitation program
Secondary outcome [6] 449052 0
Rehabilitation effectiveness - proportion of patients who demonstrate an improvement in orthostatic tolerance This is an additional primary outcome
Timepoint [6] 449052 0
Week 0 and Week 13 of rehabilitation program

Eligibility
Key inclusion criteria
Patients included in the project will be individuals with a confirmed diagnosis of Postural Orthostatic Tachycardia Syndrome. Patients who are 16 years of age or older will be eligible, as late adolescence is a common time for the onset of POTS symptoms and consequential diagnosis. Patients must also provide written consent to engage with the rehabilitation program to be included in the project. Parental or guardian consent will also be requested for any patient under the age of 18 years.

Diagnostic criteria for POTS is defined in the literature as:
- A heart rate increase of 30 beats per minute (BPM) or more (40 BPM or more in children and adolescents) and/or a heart rate
that exceeds 120 BPM within the first 10 minutes of quiet standing
- Absence of orthostatic hypotension/ absence of a blood pressure drop of more than 20/10 mmHg on standing
- Symptom duration of at least 3 months
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study if they do not have a confirmed diagnosis of POTS. Patients will also be excluded from the study should they be unable to provide informed consent to engage with the program or are unable to comply with the rehabilitation program requirements (eg. unable to attend available sessions). Patients will also be excluded from the study if they have a comorbidity or musculoskeletal complaint that would prevent safe engagement in exercise training as per the American College of Sports Medicine and local service contraindications

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
This pilot study will aim for a minimum of 60 referrals across the project to achieve a minimum sample size of 30 patients, accounting for 50% non-completion or withdrawal observed in a previous multi-centre community study. If a greater number of referrals or less attrition allows for a larger sample size, then this would further strengthen the results and evaluation. Although the proposed sample size is smaller than samples within existing literature ranging from 1 to 250 participants, this study will be the first study to pilot the integration of a tailored POTS rehabilitation pathway into an existing service in Australia, and specifically Queensland Health.

Quantitative Data analysis:
Continuous data will be assessed for normality using the Shapiro Willk and Kolmogorov Smirnov tests and Q-Q Plots. Parametric statistical tests will be used for normally distributed data. Non-normally distributed data will be log transformed in an attempt to obtain normality. If unsuccessful, non-parametric statistical tests will be used for this outcome data.
Parametric tests will include a repeated measures ANOVA to compare continuous variables with three time points (pre-, mid- and post- rehabilitation), such as questionnaire scores. Paired t-tests will compare continuous variables with two time points (pre- and post- rehabilitation), such as the active stand and six minute walk test data.
Non-parametric tests will include a Kruskal-Wallis test to compare continuous variables with three time points (pre-, mid- and post-rehabilitation, such as questionnaire scores, and Wilcoxon signed-rank test to compare continuous variables with two time points (pre- and post- rehabilitation), such as the active stand and six minute walk test data.
Qualitative Data Analysis:
Interview transcripts and PREMs data will be analysed to identify themes and key concepts to allow insight into patient experiences and inform overall acceptability. Interview transcripts will be analysed thematically and mapped to the constructs of the Theoretical Framework of Acceptability (e.g. affective attitude, burden, intervention coherence, perceived effectiveness, and self-efficacy)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/07/2025
Actual
Date of last participant enrolment
Anticipated
30/03/2026
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 319204 0
Government body
Name [1] 319204 0
Clinical Excellence Queensland - Rural and Remote Research Capacity Building Program
Country [1] 319204 0
Australia
Funding source category [2] 319189 0
Government body
Name [2] 319189 0
Clinical Excellence Queensland - Health Practitioner Research Scheme
Country [2] 319189 0
Australia
Funding source category [3] 319205 0
Government body
Name [3] 319205 0
Office of Research and Innovation - Targetted Clinical Research Fellowship
Country [3] 319205 0
Australia
Primary sponsor type
Hospital
Name
Ipswich Chronic Conditions Service - West Moreton Health
Address
Country
Australia
Secondary sponsor category [1] 321671 0
None
Name [1] 321671 0
Address [1] 321671 0
Country [1] 321671 0
Other collaborator category [1] 283545 0
University
Name [1] 283545 0
The University of Queensland
Address [1] 283545 0
Country [1] 283545 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317771 0
West Moreton Hospital and Health Service
Ethics committee address [1] 317771 0
Ethics committee country [1] 317771 0
Australia
Date submitted for ethics approval [1] 317771 0
27/04/2025
Approval date [1] 317771 0
11/06/2025
Ethics approval number [1] 317771 0
118402

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

Contacts
Principal investigator
Name 142090 0
Miss Olivia Powrie
Address 142090 0
Level 2 - Hayden Centre, 37 South Street, Ipswich, Queensland, 4305
Country 142090 0
Australia
Phone 142090 0
+61 409747209
Fax 142090 0
Email 142090 0
[email protected]
Contact person for public queries
Name 142091 0
Olivia Powrie
Address 142091 0
Level 2 - Hayden Centre, 37 South Street, Ipswich, Queensland, 4305
Country 142091 0
Australia
Phone 142091 0
+61 409747209
Fax 142091 0
Email 142091 0
[email protected]
Contact person for scientific queries
Name 142092 0
Olivia Powrie
Address 142092 0
Level 2 - Hayden Centre, 37 South Street, Ipswich, Queensland, 4305
Country 142092 0
Australia
Phone 142092 0
+61 409747209
Fax 142092 0
Email 142092 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires approval by an ethics committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Participant consent specifications for data sharing and usage



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
ProtocolNo Project Protocol - Final.pdf

Documents added automatically
No additional documents have been identified.