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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]

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

Condition category

Condition code

Cardiovascular

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]

Rehabilitation

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Patient feasibility - the proportion of patients who complete the program

Timepoint [1]

At the completion of the project

Primary outcome [2]

Rehabilitation effectiveness - the proportion of patients who report improvements in POTS Symptom Severity

Timepoint [2]

Week 0, Week 7, Week 13 and Week 26 of rehabilitation program

Primary outcome [3]

Rehabilitation effectiveness - proportion of patients who demonstrate an improvement in exercise tolerance

Timepoint [3]

Week 0, Week 7 and Week 13 of rehabilitation program

Secondary outcome [1]

Acceptability of tailored rehabilitation program by patients

Timepoint [1]

interviews will be completed in the final 3 months of the project. Analyses will occur at the completion of all interviews.

Secondary outcome [2]

Program feasibility - number of occasions of service per patient

Timepoint [2]

Analysis to occur at the completion of the project

Secondary outcome [3]

Patient feasibility - the proportion of sessions attended by patients who complete the program This is an additional primary outcome

Timepoint [3]

At the completion of the project

Secondary outcome [4]

Rehabilitation effectiveness - the proportion of patients who report improvements in fatigue This is an additional primary outcome

Timepoint [4]

Week 0, Week 7, Week 13 and Week 26 of rehabilitation program

Secondary outcome [5]

Rehabilitation effectiveness - the proportion of patients who report improvements health-related quality of life This is an additional primary outcome

Timepoint [5]

Week 0, Week 7, Week 13 and Week 26 of rehabilitation program

Secondary outcome [6]

Rehabilitation effectiveness - proportion of patients who demonstrate an improvement in orthostatic tolerance This is an additional primary outcome

Timepoint [6]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Clinical Excellence Queensland - Health Practitioner Research Scheme

Address [1]

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Clinical Excellence Queensland - Rural and Remote Research Capacity Building Program

Address [2]

Country [2]

Australia

Funding source category [3]

Government body

Name [3]

Office of Research and Innovation - Targetted Clinical Research Fellowship

Address [3]

Country [3]

Australia

Primary sponsor type

Hospital

Name

Ipswich Chronic Conditions Service - West Moreton Health

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

The University of Queensland

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

West Moreton Hospital and Health Service

Ethics committee address [1]

https://www.health.qld.gov.au/ohmr/html/regu/hrec_contacts.asp

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/04/2025

Approval date [1]

11/06/2025

Ethics approval number [1]

118402

Summary

Brief summary

In recent years, there has been a notable increase in the prevalence of Postural Orthostatic Tachycardia Syndrome (POTS), a common form of dysautonomia. POTS is a debilitating condition resulting in exercise intolerance, a diminished ability to complete activities of daily living and profoundly impacts quality of life. Access to health care and services, including rehabilitation tailored for individuals with POTS is limited across Australia. Tailoring traditional cardiac rehabilitation services to better accommodate for individuals with POTS could be key to bridging the gaps in access to care for this cohort. This project aims to evaluate the feasibility, effectiveness and acceptability of the integration of a tailored rehabilitation pathway, reviewed by people with lived experience with POTS, into an existing cardiac rehabilitation service. This pathway will provide patients with 12 weeks of supervised exercise rehabilitation (phase one) before transitioning patients to a further 12 weeks of unsupervised exercise (phase two). At three timepoints, assessments will be completed to evaluate the impact of rehabilitation on exercise tolerance, symptom severity and quality of life. Patients will be followed up via phone across phase two to evaluate the maintenance of exercise after the completion of the supervised rehabilitation program. This research has potential to redirect the future of POTS rehabilitation in the public health system, bridging the existing gaps to care whilst importantly supporting improvements in exercise tolerance, health-related quality of life and activities of daily living for people with POTS.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Miss Olivia Powrie

Address

Level 2 - Hayden Centre, 37 South Street, Ipswich, Queensland, 4305

Country

Australia

Phone

+61 409747209

Fax

[email protected]

Contact person for public queries

Name

Olivia Powrie

Address

Level 2 - Hayden Centre, 37 South Street, Ipswich, Queensland, 4305

Country

Australia

Phone

+61 409747209

Fax

[email protected]

Contact person for scientific queries

Name

Olivia Powrie

Address

Level 2 - Hayden Centre, 37 South Street, Ipswich, Queensland, 4305

Country

Australia

Phone

+61 409747209

Fax

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Protocol	No			Project Protocol - Final.pdf

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically