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PrehabilitationNCT05364879

Prehabilitation for Ovarian Cancer Patients

A study testing Prehabilitation Exercise Intervention in people with Prehabilitation and Exercise, run by Nova Scotia Health Authority at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Individuals with ovarian cancer have very poor survival rates. This is because the cancer is not usually detected until it has reached advanced stages. How long an individual survives also is determined by the cancer treatment they receive. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Prehabilitation, Exercise, Frailty
What is being tested?
Prehabilitation Exercise Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteCanada
Study dates
3 Jan 2023to 31 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years or older
  • Have a confirmed diagnosis of stage III or IV ovarian cancer
  • Scheduled to receive cytoreductive surgery as part of their treatment plan
  • Must have a minimum of 4-weeks between the time of study enrollment and scheduled surgery
  • Be able to attend in-person and/or virtual exercise sessions
  • Be fluent in English
  • Have oncologist approval

Who cannot join

  • Have already completed surgery
  • Unstable cardiac or respiratory disease, injury or any other co-morbid disease that may make it unsafe for participants to exercise
  • Significant cognitive impairment (e.g., do not have the capacity to consent, unable to follow exercise instructions)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Scott Grandy, PhD contact

902-494-1145

grandy@dal.ca

Canada1 site, 1 recruiting
  • Nova Scotia Health

    Halifax, Nova Scotia, B3L 4P1

    Scott Grandy, MD, 902-494-4303, scott.grandy@dal.ca

    Recruiting

Other trials in Canada

About this study

Official title: The Impact of Prehabilitation Exercise on Frailty and Treatment Outcomes in Ovarian Cancer Patients

Individuals with ovarian cancer have very poor survival rates. This is because the cancer is not usually detected until it has reached advanced stages. How long an individual survives also is determined by the cancer treatment they receive. Although there are best treatment practices to improve survival, some women have other conditions that limit treatment options. One such condition seen in as many as 50% of women with advanced ovarian cancer is frailty (an age-related decline in function and health). This is a major concern as doctors will often have to change how the cancer is treated based on the patient being frail. For example, patients living with frailty are less likely to have their full tumor removed during surgery. They are also more likely to have complications with surgery, stay in the hospital longer, and recover less well from surgery overall. Patients living with frailty also are more likely to experience delays in their chemotherapy starting, receive lower doses of chemotherapy and/or receive fewer cycles of chemotherapy. These changes in treatment may decrease how long a patient survives after diagnosis. Thus, research is needed to explore strategies to decrease frailty in patients who require treatment for advanced ovarian cancer. An option gaining more attention is physical exercise (e.g. walking, repeatedly rising from a chair). Exercise performed before surgery, which is called prehabilitation, can improve how well a patient recovers after surgery and increase how long they survive. Research has shown that prehabilitation is very beneficial for patients undergoing surgery for heart disease. However, it is not clear whether prehabilitation works for those with advanced ovarian cancer that are going to have surgery. Therefore, the investigators want to explore how a 4+ week exercise program performed while waiting for surgery for advanced ovarian cancer changes frailty and how a patient recovers after surgery. The investigators will specifically look whether the exercise program: 1) reduces how frail a patient is before surgery; 2) improves how well the patient recovers after surgery; and 3) affects the patient's chemotherapy treatment plan. This study will provide important information about the ability of prehabilitation exercise to improve surgical and treatment outcomes in women with advanced ovarian cancer. Overall, it is believed that exercise has the potential to improve the survival of advanced ovarian cancer patients.

Being tested
Prehabilitation Exercise Intervention
Medical subject headings
Motor Activity, Frailty, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prehabilitation Exercise InterventionBehavioural

    The exercise intervention will consist of light-to-moderate intensity aerobic, resistance, and mobility exercises. These exercises will be performed in a circuit type manner. Participants will perform similar exercises that are modified to meet their individual abilities. Exercise intensity, modifications and substitutions will be determined for each participant based on their medical history, 6 minute walk test results, and baseline frailty scores. Exercise sessions will be performed 3x/wk beginning at 30 min and progressing to 60-min as tolerated for a minimum of four weeks but will continue up until the time of the participants surgery. A hybrid approach will be used for the exercise sessions whereby the participant must attend the first exercise session in person and subsequent sessions will be delivered virtually. Sessions will be overseen by the study Clinical Exercise Physiologist.

Study groups in NCT05364879
Study groupRoleWhat they receive
InterventionExperimentalCircuit-based prehabilitation exercise intervention
Receives: Behavioral: Prehabilitation Exercise Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frailty Change (baseline to post exercise intervention)

    Frailty will be assessed using the Clinical Frailty Scale (CFS). The CFS is a The CFS is a 9-point scale (1 - very fit, through very severely frail to 9 - terminally ill) developed for healthcare professionals to summarize the overall level of fitness/frailty of an individual. The CFS covers domains of mobility, energy, physical activity, and function. The higher the score on the CFS the more frail/less fit an individual is.

    Measured: Change from baseline to end of 4+ week intervention (pre-surgery)

  2. Frailty Change (baseline to 1-month post surgery)

    Frailty will be assessed using the Clinical Frailty Scale (CFS). The CFS is a The CFS is a 9-point scale (1 - very fit, through very severely frail to 9 - terminally ill) developed for healthcare professionals to summarize the overall level of fitness/frailty of an individual. The CFS covers domains of mobility, energy, physical activity, and function. The higher the score on the CFS the more frail/less fit an individual is.

    Measured: Change from baseline to about 1-month post-surgery

  3. Frailty Change (baseline to 3-months post surgery)

    Frailty will be assessed using the Clinical Frailty Scale (CFS). The CFS is a The CFS is a 9-point scale (1 - very fit, through very severely frail to 9 - terminally ill) developed for healthcare professionals to summarize the overall level of fitness/frailty of an individual. The CFS covers domains of mobility, energy, physical activity, and function. The higher the score on the CFS the more frail/less fit an individual is.

    Measured: Change from baseline to about 3-month post-surgery

  4. Surgical Complexity Score (1-month post surgery)

    Surgical complexity will be assessed based on Enhanced Recovery After Surgery (ERAS) guidelines. Complexity scores will be interpreted as "low" (3 or fewer points), "intermediate" (4-7 points), and "high" (8 or more points).

    Measured: Surgical complexity will be assessed about 1-month post-surgery.

  5. Post-Surgical Outcomes (1-month post surgery)

    Post-surgical outcomes will be assessed based on Enhanced Recovery After Surgery (ERAS) guidelines. Specific outcomes will include post-op glucose control, analgesia usage, pain, daily weight, early mobilization, and post-operative complications.

    Measured: Post-surgical outcomes will be assessed about 1-month post-surgery.

  6. Surgical Complications (1-month post surgery)

    Surgical complications will be assessed based on Enhanced Recovery After Surgery (ERAS) guidelines. Specific outcomes will include length of hospital stay and number of readmissions.

    Measured: Surgical complications will be assessed post-surgery about 1-month post-surgery.

  7. Chemotherapy completion rates (End of Cycle 1)

    Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment

    Measured: At the end of cycle 1 (each cycle is 3 weeks). Immediately after the procedure.

  8. Chemotherapy completion rates (End of Cycle 2)

    Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment

    Measured: At the end of cycle 2 (each cycle is 3 weeks). Immediately after the procedure.

  9. Chemotherapy completion rates (End of Cycle 3)

    Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment

    Measured: At the end of cycle 3 (each cycle is 3 weeks). Immediately after the procedure.

  10. Chemotherapy completion rates (End of Cycle 4)

    Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment

    Measured: At the end of cycle 4 (each cycle is 3 weeks). Immediately after the procedure.

  11. Chemotherapy completion rates (End of Cycle 5)

    Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment

    Measured: At the end of cycle 5 (each cycle is 3 weeks). Immediately after the procedure.

  12. Chemotherapy completion rates (End of Cycle 6)

    Chemotherapy completion rates will be examined through documentation of total drug dose received, changes in dose, cycle delays, and/or discontinuation of treatment

    Measured: At the end of cycle 6 (each cycle is 3 weeks). Immediately after the procedure.

Secondary outcomes (15)
  1. Body Mass Index Change (baseline to post exercise intervention)

    Weight (kg) and height (m) will be used to calculate BMI

    Measured: Change in BMI from baseline to post 4+ week exercise intervention

  2. Body Mass Index Change (baseline to 1-month post surgery)

    Weight (kg) and height (m) will be used to calculate BMI

    Measured: Change in BMI from baseline to about 1-month post surgery.

  3. Body Mass Index Change (baseline to 3-months post surgery)

    Weight (kg) and height (m) will be used to calculate BMI

    Measured: Change in BMI from baseline to about 3-month post surgery.

  4. Aerobic Fitness Change (baseline to post exercise intervention)

    The six-minute walk will be used to calculate aerobic fitness

    Measured: Change in aerobic fitness from baseline to post 4+ week intervention (pre-surgery)

  5. Aerobic Fitness Change (baseline to 1-month post surgery)

    The six-minute walk will be used to calculate aerobic fitness

    Measured: Change in aerobic fitness from baseline to about 1-month post surgery

  6. Aerobic Fitness Change (baseline to 3-months post surgery)

    The six-minute walk will be used to calculate aerobic fitness

    Measured: Change in aerobic fitness from baseline to about 3-months post surgery

  7. Muscular Fitness Change (baseline to post exercise intervention)

    Muscular fitness will be assessed using the Canadian Society of Exercise Physiology's Physical Activity Training Protocol (CSEP-PATH) and will include the timed sit-to-stand and grip strength.

    Measured: Change in muscular fitness will be assessed from baseline to post exercise intervention (pre-surgery)

  8. Muscular Fitness Change (baseline to about 1-month post surgery)

    Muscular fitness will be assessed using the Canadian Society of Exercise Physiology's Physical Activity Training Protocol (CSEP-PATH) and will include the timed sit-to-stand and grip strength.

    Measured: Change in muscular fitness will be assessed from baseline to 1-month post surgery.

  9. Muscular Fitness Change (baseline to about 3-months post surgery)

    Muscular fitness will be assessed using the Canadian Society of Exercise Physiology's Physical Activity Training Protocol (CSEP-PATH) and will include the timed sit-to-stand and grip strength.

    Measured: Change in muscular fitness will be assessed from baseline to 3-months post surgery.

  10. Health-Related Quality of Life Change (baseline to post exercise intervention

    Health-related quality of life will be assess using the EuroQoL five dimensional questionnaire (EQ-5D-5L). The EQ-5D-DL measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; higher scores indicate higher problems

    Measured: Chang in health-related quality of life from baseline to post 4+ week intervention (pre-surgery)

  11. Health-Related Quality of Life Change (baseline to 1-month post surgery)

    Health-related quality of life will be assess using the EuroQoL five dimensional questionnaire (EQ-5D-5L). The EQ-5D-DL measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; higher scores indicate higher problems

    Measured: Chang in health-related quality of life from baseline to about 1-month post surgery

  12. Health-Related Quality of Life Change (baseline to 3-months post surgery)

    Health-related quality of life will be assess using the EuroQoL five dimensional questionnaire (EQ-5D-5L). The EQ-5D-DL measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; higher scores indicate higher problems

    Measured: Change in health-related quality of life from baseline to about 3-months post surgery

  13. Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to post exercise intervention)

    The Functional Assessment of Cancer Therapy for Ovarian Cancer (FACT-O) will be used to measure cancer-specific quality of life; 27-item questionnaire with higher scores indicating higher overall quality of life.

    Measured: Change in FACT-O from baseline to post 4+ week intervention (pre-surgery)

  14. Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to 1-month post surgery)

    The Functional Assessment of Cancer Therapy for Ovarian Cancer (FACT-O) will be used to measure cancer-specific quality of life; 27-item questionnaire with higher scores indicating higher overall quality of life.

    Measured: Change in FACT-O from baseline to about 1-month post surgery

  15. Physical, Functional, Emotional, and Social/Family Quality of Life Change (baseline to 3-months post surgery)

    The Functional Assessment of Cancer Therapy for Ovarian Cancer (FACT-O) will be used to measure cancer-specific quality of life; 27-item questionnaire with higher scores indicating higher overall quality of life.

    Measured: Change in FACT-O from baseline to about 3-months post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2022
  2. Study start3 Jan 2023
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05364879
Sponsor's protocol ID
NSH Adv Ovarian Cancer Prehab
Status last verified
May 2026
First submitted
30 Mar 2022
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Prehabilitation Exercise Intervention in people with Prehabilitation and Exercise, run by Nova Scotia Health Authority at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Scott Grandy, PhD (902-494-1145, grandy@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frailty Change (baseline to post exercise intervention) (time frame: Change from baseline to end of 4+ week intervention (pre-surgery)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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