Recruiting

Prehabilitation

Sponsor:

Nova Scotia Health Authority

Code:

NCT05364879

Conditions

Prehabilitation

Exercise

Frailty

Ovarian Cancer

Surgical Complication

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prehabilitation Exercise Intervention

Study Details

Brief 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. 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.

Conditions

Prehabilitation

Exercise

Frailty

Ovarian Cancer

Surgical Complication

Study ID

NCT05364879

Start date

Jan 3, 2023

Status verified date

May, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Design

Enrollment

108 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention

Circuit-based prehabilitation exercise intervention

Interventions

Prehabilitation Exercise Intervention

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.

Primary outcome measure

  • Frailty Change (baseline to post exercise intervention) [ Time Frame: Change from baseline to end of 4+ week intervention (pre-surgery) ]
  • Frailty Change (baseline to 1-month post surgery) [ Time Frame: Change from baseline to about 1-month post-surgery ]
  • Frailty Change (baseline to 3-months post surgery) [ Time Frame: Change from baseline to about 3-month post-surgery ]
  • Surgical Complexity Score (1-month post surgery) [ Time Frame: Surgical complexity will be assessed about 1-month post-surgery. ]
  • Post-Surgical Outcomes (1-month post surgery) [ Time Frame: Post-surgical outcomes will be assessed about 1-month post-surgery. ]
  • Surgical Complications (1-month post surgery) [ Time Frame: Surgical complications will be assessed post-surgery about 1-month post-surgery. ]
  • Chemotherapy completion rates (End of Cycle 1) [ Time Frame: At the end of cycle 1 (each cycle is 3 weeks). Immediately after the procedure. ]
  • Chemotherapy completion rates (End of Cycle 2) [ Time Frame: At the end of cycle 2 (each cycle is 3 weeks). Immediately after the procedure. ]
  • Chemotherapy completion rates (End of Cycle 3) [ Time Frame: At the end of cycle 3 (each cycle is 3 weeks). Immediately after the procedure. ]
  • Chemotherapy completion rates (End of Cycle 4) [ Time Frame: At the end of cycle 4 (each cycle is 3 weeks). Immediately after the procedure. ]
  • Chemotherapy completion rates (End of Cycle 5) [ Time Frame: At the end of cycle 5 (each cycle is 3 weeks). Immediately after the procedure. ]
  • Chemotherapy completion rates (End of Cycle 6) [ Time Frame: At the end of cycle 6 (each cycle is 3 weeks). Immediately after the procedure. ]

Central Contacts and Locations

Central contacts

Locations

Nova Scotia Health

Recruiting

Halifax, Nova Scotia, Canada, B3L 4P1

Contacts

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

Jun 1, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2026-06-01.