Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001308381p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
13/10/2026
Date registered
Help: Date registered
30/10/2026
Date last updated
Help: Date last updated
30/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
30/10/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of an exercise and education program on quality of life for people with postural orthostatic tachycardia syndrome (POTS)
Scientific title
The Feasibility and Effectiveness of an Individualised Exercise and Education Rehabilitation Program for Individuals with Postural Orthostatic Tachycardia Syndrome (POTS): a multi-site randomised controlled trial
Additional trial identifiers [1] 318509 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Postural Orthostatic Tachycardia Syndrome (POTS) 343686 0
Condition category
Condition code
Physical Medicine / Rehabilitation 339807 339807 0 0
Other physical medicine / rehabilitation
Other 339808 339808 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention in this study is an individualised 12-week exercise and education rehabilitation program for individuals with Postural Orthostatic Tachycardia Syndrome (POTS).

Participants allocated to the intervention group will be asked to attend two supervised in-person rehabilitation sessions per week for the 12 weeks (24 sessions total). Each session will last for up to 60 minutes.

Sessions will be delivered in a small group environment (clinician to participant ratio of 1:4) in local community health rehabilitation facilities. However, all participants in the intervention group will complete their own individualised exercise prescription and will receive individualised education across the 12 weeks.

Each exercise prescription will include a combination of aerobic (eg. recumbent cycling, rowing, arm ergometer) and resistance (eg. body weight, resistance band, machine weight or free weight) exercises. Specific exercises will be individualised based on musculoskeletal considerations, exercise history, participant preferences and positional tolerance (eg.. supine, recumbent, upright). Exercise intensity will progress from low to moderate across the 12 weeks, assessed via the Borg RPE scale. Any changes to the prescribed exercises will be documented each session to monitor adherence to the intervention.

Rehabilitation sessions will be delivered by Accredited Exercise Physiologists with prior experience in delivering rehabilitation for individuals with chronic conditions.

Three assessments (baseline, mid-way and final) will be completed for all participants (intervention and control group). Physical activity will be documented at each time point to monitor adherence to the allocated group.
Intervention code [1] 335410 0
Rehabilitation
Intervention code [2] 335411 0
Lifestyle
Description of the comparator or control
The comparator group in this study will be a waitlist control group. This group will complete the three specified assessments (baseline, mid-way and final) but will not receive any exercise or education intervention. The assessment will capture any changes to physical activity across the intervention to monitor adherence to group allocation.
Control group
Active

Outcomes
Primary outcome [1] 346986 0
Quality of life
Timepoint [1] 346986 0
Baseline, mid-way (week 7 post-commencement of intervention) and final (week 13 post-commencement of intervention)
Secondary outcome [1] 468481 0
Fatigue severity
Timepoint [1] 468481 0
Baseline, mid-way (week 7 post-commencement of intervention) and final (week 13 post-commencement of intervention)
Secondary outcome [2] 468482 0
POTS symptom burden
Timepoint [2] 468482 0
Baseline, mid-way (week 7 post-commencement of intervention) and final (week 13 post-commencement of intervention)
Secondary outcome [3] 468483 0
Exercise capacity
Timepoint [3] 468483 0
Baseline, mid-way (week 7 post-commencement of intervention) and final (week 13 post-commencement of intervention)
Secondary outcome [4] 468484 0
Multi-site feasibility
Timepoint [4] 468484 0
Attendance rate calculated for each participant at the end of week 12 post-commencement of the intervention. Attendance rate for each site calculated after the final cohort of participants completes week 12 of the intervention
Secondary outcome [5] 469715 0
Multi-site feasibility
Timepoint [5] 469715 0
Completion rate for each site calculated after the final cohort of participants completes week 12 of the intervention.

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion if they:
- Have a confirmed diagnosis of POTS
- Are 18 years of age or older
- Provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Participants will be excluded from the study if they:
- Have any comorbidity or musculoskeletal complaint that would prevent safe engagement with exercise as per the American College of Sports Medicine contraindications
- Unable to attain medical clearance for exercise

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)
Baseline testing will occur prior to randomisation and group allocation. The outcome assessor will remain blinded to group allocation throughout the study. An online central randomisation service will be utilised to allow allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An online central randomisation service (sealed envelopes) will be utilised for random sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size calculations were completed using the quality of life outcome data from a pilot study completed by the research team.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2027
Actual
Date of last participant enrolment
Anticipated
1/07/2027
Actual
Date of last data collection
Anticipated
1/10/2027
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 30265 0
Ipswich Hospital - Ipswich
Recruitment hospital [2] 30266 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 46667 0
4305 - Ipswich
Recruitment postcode(s) [2] 46668 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 323087 0
Charities/Societies/Foundations
Name [1] 323087 0
Philanthropic Donation
Country [1] 323087 0
Australia
Funding source category [2] 323129 0
Charities/Societies/Foundations
Name [2] 323129 0
WIshlist Hospital Foundation
Country [2] 323129 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 326040 0
Hospital
Name [1] 326040 0
West Moreton Health
Address [1] 326040 0
Country [1] 326040 0
Australia
Secondary sponsor category [2] 326044 0
Hospital
Name [2] 326044 0
Sunshine Coast health
Address [2] 326044 0
Country [2] 326044 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 321489 0
Darling Downs Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 321489 0
Ethics committee country [1] 321489 0
Australia
Date submitted for ethics approval [1] 321489 0
29/09/2026
Approval date [1] 321489 0
Ethics approval number [1] 321489 0

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

Contacts
Principal investigator
Name 153878 0
Miss Olivia Powrie
Address 153878 0
West Moreton Health, Level 2, 37 South Street, Ipswich, QLD, 4305
Country 153878 0
Australia
Phone 153878 0
+61 409747209
Fax 153878 0
Email 153878 0
[email protected]
Contact person for public queries
Name 153879 0
Olivia Powrie
Address 153879 0
West Moreton Health, Level 2, 37 South Street, Ipswich, QLD, 4305
Country 153879 0
Australia
Phone 153879 0
+61 409747209
Fax 153879 0
Email 153879 0
[email protected]
Contact person for scientific queries
Name 153880 0
Olivia Powrie
Address 153880 0
West Moreton Health, Level 2, 37 South Street, Ipswich, QLD, 4305
Country 153880 0
Australia
Phone 153880 0
+61 409747209
Fax 153880 0
Email 153880 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?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
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?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.