ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626001153303p

Ethics application status

Not yet submitted

Date submitted

10/07/2026

Date registered

16/09/2026

Date last updated

16/09/2026

Date data sharing statement initially provided

16/09/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

Pilates exercise for adults with advanced cancer: A pilot study evaluating feasibility, safety and effectiveness.

Scientific title

The feasibility and efficacy of Pilates exercise in people diagnosed with advanced cancer: A pilot randomised waitlist control trial.

Additional trial identifiers [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Advanced Cancer

Metastatic Cancer

Condition category

Condition code

Cancer

Any cancer

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

Intervention group: Pilates Exercise Program
Participants allocated to the intervention group will undertake an 8-week supervised Pilates mat-based exercise program delivered by an accredited exercise physiologist who is also a certified Pilates instructor. The Pilates intervention will comprise:
2 supervised Pilates sessions per week for 8 weeks, 60 minutes per session, 1 face-to-face session weekly, and 1 telehealth session weekly. Small group format (approx. 3–5 participants per class). Delivered at Southern Cross University, and online via telehealth. Exercises will be individualised and modified according to participant ability, symptoms, and safety, and progression is individualised. Exercise intensity will be monitored through Rating of Perceived Exertion (RPE). Symptom monitoring adherence and compliance will be monitored (i.e., session attendance, drop out, drop out reason, and study completion rate). Any adverse events will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) V6.0 (National Cancer Institute, 2017) and reported. Examples of Pilates exercises that will be prescribed as part of the intervention include: Bridging, dead bugs, arm arcs, chest lift, side to side, book openings, prone spine extension, quadruped and standing roll down.

Intervention code [1]

Rehabilitation

Intervention code [2]

Lifestyle

Intervention code [3]

Treatment: Other

Description of the comparator or control

Usual care / waitlist control group: Will continue their usual care for the 8-week trial period. The usual care group will receive no Pilates or exercise intervention during the 8-week trial period. Following the initial Pilates 8-week intervention period, the usual care (control) group will be offered the same 8-week Pilates intervention contingent on demonstration of feasibility and safety.

Control group

Active

Outcomes

Primary outcome [1]

Feasibility of the Pilates intervention.

Timepoint [1]

Throughout recruitment and intervention period; assessed continuously and summarised at study completion.

Primary outcome [2]

Safety of the Pilates intervention.

Timepoint [2]

Recorded throughout the intervention period at every Pilates intervention session and whenever an adverse event occurs.

Secondary outcome [1]

Physical Function: Grip Strength test

Timepoint [1]

Pilates and Usual Care Group: Baseline and post-completion of final session. Pilates group only: Follow-up (8 weeks post-completion of final session).

Secondary outcome [2]

Lower body strength / function

Timepoint [2]

Pilates and Usual Care Group: Baseline and post-completion of final session. Pilates group only. Follow-up (8 weeks post-completion of final session).

Secondary outcome [3]

Dynamic Balance and Mobility (composite outcome)

Timepoint [3]

Pilates and Usual Care Group: Baseline and post-completion of final session. Pilates group only: Follow-up (8 weeks post-completion of final session).

Secondary outcome [4]

Static Balance

Timepoint [4]

Pilates and Usual Care Group: Baseline and post-completion of final session. Pilates group only: Follow-up (8 weeks post-completion of final session).

Secondary outcome [5]

Physical Activity

Timepoint [5]

Pilates and Usual Care Group: Baseline and post-completion of final session. Pilates group only; Follow-up (8 weeks post-completion of final session).

Secondary outcome [6]

Psychosocial Outcomes Quality of Life

Timepoint [6]

Pilates and Usual Care Group: Baseline and post-completion of final session. Pilates group only, follow-up (8 weeks post-completion of final session).

Secondary outcome [7]

Sleep Quality

Timepoint [7]

Pilates and Usual Care Group: Baseline and post-completion of final session. Pilates group only, follow-up (8 weeks post-completion of final session).

Secondary outcome [8]

Safety

Timepoint [8]

At each Pilates session, ad hoc at the time of the adverse event.

Eligibility

Key inclusion criteria

- Adults aged 18 years and older
- Confirmed diagnosis of advanced cancer
- Not participating in structured exercise greater than or equal to twice/week during previous 3 months
- Able to attend Southern Cross University at least once weekly
- Medical clearance to undertake Pilates exercise intervention
- Adequate English language skills
- Capacity to provide informed consent
- Access to a device capable of telehealth participation
- Participants receiving active cancer treatment or not on treatment are eligible

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

- Inability to understand study procedures or provide informed consent
- Contraindications to exercise determined by treating clinician
- Severe cardiovascular, musculoskeletal or medical conditions precluding participation
- ECOG performance status > 2
- CTCAE > Grade 2
- Current moderate-to-severe bone pain
- Already achieving recommended cancer-specific exercise levels

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)

Sequentially numbered opaque sealed envelopes prepared by an independent researcher.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer-generated random allocation sequence prepared by an independent researcher not involved in recruitment or intervention delivery.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Sample size required to address the feasibility study aims and objectives is based on the evidence from the systematic review findings conducted by the SCU research team, RCT studies total sample sizes ranged from 28 to 110 participants, with Pilates group sample sizes ranging from 9 to 36 participants. The feasibility trial sample size is consistent with Montgomery's (2025) suggestions that feasibility trial sample sizes mirror what is done in RCTs, and define outcomes and progression criteria (i.e., recruitment, retention, adherence rates and implementation) to justify planning a future definitive trial (Montgomery, 2025). Based on this evidence the total sample size for this feasibility study will be 20 – 30 participants.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

4/01/2027

Actual

Date of last participant enrolment

Anticipated

29/01/2027

Actual

Date of last data collection

Anticipated

31/08/2027

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

University

Name

Southern Cross University

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

North Coast NSW Human Research Ethics Committee

Ethics committee address [1]

http://nnswlhd.health.nsw.gov.au/about/northern-nsw-local-health-district/human-research-ethics-and-governance/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/10/2026

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

The purpose of this study is to investigate the feasibility, safety and acceptability of a Pilates exercise intervention for adults living with advanced cancer. Additionally, the aim is to also understand the impact of a Pilates exercise intervention on the strength, balance, physical activity, quality of life and sleep quality of adults living with advanced cancer.

Who is it for?
This study is for adults aged 18 years and older living with a confirmed diagnosis of an advanced cancer who are able to attend and perform Pilates in-person and on-line (telehealth) across 8 weeks. Participants must not currently be engaging in structured exercise for more than 2x per week over the previous 3 months.

Study details
Participants will be randomised to either attend Pilates intervention or to continue to receive usual care. Participants allocated to the Pilates intervention will undertake 2x 60 minute supervised mat-based Pilates sessions per week for 8-weeks, delivered by a certified Pilates instructor who is also an accredited exercise physiologist. Sessions are in a small group format of up to 3 participants per class, and each week one of the two sessions will be delivered in-person (face-to-face) while the second session will be delivered on-line (telehealth).

Participants in this study will completed a variety of physical tests, including but not limited to: grip strength test, sit-to-stand test, up-and-go test, balance. Participants will also be asked to complete questionnaires to assess quality of life, sleep, and physical activity.

It is hoped that the findings from this study will help determine whether Pilates could become a practical component of cancer rehabilitation programs and inform the design of a larger clinical trial.

Trial website

Trial related presentations / publications

Public notes

ESSA Conference abstract from the results of the Systematic Review
Scicluna R, Sidhu D, Wilkie JC, Buchan J, Turner M, Toohey K. PILATES IN CANCER REHABILITATION: EVIDENCE, GAPS, AND OPPORTUNITIES. Journal of Clinical Exercise Physiology. 2026 Apr;15(s2):158–158. doi:10.31189/2165-7629-15-s2.158

Contacts

Principal investigator

Name

Dr Carmen Hansen

Address

Tweed Valley Hospital, 771 Cudgen Road, Cudgen, NSW 2487

Country

Australia

Phone

+61402424504

Fax

[email protected]

Contact person for public queries

Name

Rachel Scicluna

Address

Southern Cross University Gold Coast. Southern Cross Drive, Bilinga QLD 4225, Australia

Country

Australia

Phone

+61402424504

Fax

[email protected]

Contact person for scientific queries

Name

Rachel Scicluna

Address

Southern Cross University Gold Coast. Southern Cross Drive, Bilinga QLD 4225, Australia

Country

Australia

Phone

+61402424504

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: Individual participant data will not be publicly available due to ethical and privacy considerations associated with a small clinical population; however, aggregate results will be reported through publications and presentations.

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
Study protocol			[email protected]		NNSWLHD Pilates and Cancer Feasibility Study Protocol_V8.docx

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Protocol	No		Study Protocol	NNSWLHD Pilates and Cancer Feasibility Study Protocol_V8.docx

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically