Pre-Surgery Exercise for Frailty

Overseen By Karina Branje

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Cardiac, Neurological, Orthopedic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a home-based exercise program can reduce surgery complications and patient-reported disability afterward. Participants will either join an exercise group or receive standard health advice. The exercise group will perform strength, aerobic, and flexibility exercises at home three times a week for three weeks. Individuals aged 60 or older, with surgery planned requiring at least a two-day hospital stay, and experiencing frailty (difficulty in daily living activities) might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance recovery for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this exercise program is safe for pre-surgery patients?

Research has shown that exercise is generally safe and beneficial for older adults, including those who are frail. Studies have found that exercise strengthens muscles and lowers the risk of falls in older adults who are frail or nearly frail. Exercise programs that include various activities can also enhance physical and mental abilities. While exercise can be challenging, older adults usually manage it well.

Similar studies reported no major serious problems caused by exercise programs. This suggests that joining a structured exercise program, like the one in this trial, is likely safe for most people. Participants will also receive weekly phone calls to ensure their safety and provide support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the pre-surgery exercise program for frailty because it takes a proactive approach to improving patient strength and resilience before surgery. Unlike standard care, which might focus on managing frailty with medications or post-surgery rehabilitation, this program is a home-based, multimodal exercise regimen that combines strength training, aerobic exercise, and flexibility exercises. This unique approach empowers patients to actively participate in their own care, potentially enhancing surgical outcomes and reducing recovery time. Additionally, the program's personalized support through weekly phone calls helps ensure adherence and addresses individual needs, making it a promising alternative to traditional methods.

What evidence suggests that this exercise program is effective for reducing complications and disability after surgery?

Research has shown that exercise can greatly improve the health of frail older adults. Exercise routines that include strength training, aerobic activities, and flexibility exercises increase muscle strength and lower the risk of falls. These routines also enhance overall physical health and mental abilities, such as thinking and memory. In this trial, participants in the Exercise Group will follow a home-based program that combines exercises to build muscle and improve balance, potentially reducing problems and disability after surgery. Meanwhile, the Control Group will receive the World Health Organization's recommendations for physical activity for people aged 65 and older, along with a guide to healthy eating for older adults. ^{1 2 3 4 6}

Who Is on the Research Team?

Daniel I McIsaac, MD,MPH,FRCPC

Principal Investigator

The Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for people aged 60 or older who are considered frail (with a Clinical Frailty Scale score of at least 4/9) and have elective surgery planned that will require a hospital stay of two days or more. They must be able to start the exercise program between 3 and 12 weeks before their surgery date. Those with certain heart, nerve, or bone conditions, unable to communicate in English or French, having palliative surgeries, or unreachable by phone cannot join.

Inclusion Criteria

My surgery is scheduled between 3 to 12 weeks from now.

I am scheduled for surgery that will require me to stay in the hospital for at least 2 days.

I am 60 years old or older.

Exclusion Criteria

I have had surgery to relieve symptoms.

I cannot communicate in English or French.

I have had heart, brain, or bone surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Exercise

Participants in the exercise group engage in a home-based, multimodal exercise prehabilitation program for three weeks, consisting of strength training, aerobic exercise, and flexibility exercises.

3 weeks

Weekly phone calls for adherence and support

Surgery and Immediate Postoperative

Participants undergo major elective non-cardiac surgery and are monitored for in-hospital complications using the POMS tool.

Up to 30 days

Follow-up

Participants are monitored for patient-reported disability and other outcomes at 30, 90, and 365 days post-operation.

12 months

Follow-up calls at 30, 90, and 365 days

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Group

Trial Overview The PREPARE Trial is testing if doing exercises at home before surgery can help reduce complications and disability after surgery in older adults with frailty. Participants are split into two groups randomly: one group follows the exercise program while the other does not.

How Is the Trial Designed?

Group I: Exercise Group Experimental Treatment 1 Intervention

The intervention is a home-based, multimodal exercise prehabilitation program. Exercise is prescribed in one-hour sessions, performed a minimum of three times per week for three weeks, consisting of: 1) strength training, 2) aerobic exercise and 3) flexibility. The intervention group will receive weekly phone calls to gauge adherence, suggest modifications, provide support and track any adverse events.

Group II: Control Group Active Control 1 Intervention

The control group will receive the World Health Organization recommendations for physical activity for people greater or equal to the age of 65 years old pamphlet, as well as a guide to healthy eating for older adults.

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Published Research Related to This Trial

Pelvic floor muscle exercises are highly effective for treating urinary stress incontinence in women, with studies showing up to a 70% improvement in symptoms after proper training.

Supervised exercise programs led by physiotherapists or continence nurses are more effective than unsupervised methods, and a minimum of three months of training is recommended for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor exercise for urinary incontinence: a systematic literature review. Price, N., Dawood, R., Jackson, SR.[2022]

This trial will assess the effectiveness of a home-based exercise prehabilitation program over 3 weeks for frail patients over 60 undergoing elective cancer surgery, aiming to improve their postoperative functional outcomes, particularly measured by the 6-minute walk test.

The study will also evaluate secondary outcomes such as quality of life and complications, providing a comprehensive understanding of how exercise prehabilitation can benefit frail older adults in the surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PREHAB study: a protocol for a prospective randomised clinical trial of exercise therapy for people living with frailty having cancer surgery. McIsaac, DI., Saunders, C., Hladkowicz, E., et al.[2022]

A home-based prehabilitation program for older adults with frailty undergoing cancer surgery did not show significant improvements in postoperative recovery, as measured by the 6-minute walk test and other secondary outcomes, in a study involving 204 participants.

However, higher adherence to the prehabilitation program (≥80%) was associated with better outcomes, suggesting that how well patients follow the program may influence its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based prehabilitation with exercise to improve postoperative recovery for older adults with frailty having cancer surgery: the PREHAB randomised clinical trial. McIsaac, DI., Hladkowicz, E., Bryson, GL., et al.[2022]

A randomized controlled trial involving 51 women undergoing surgery for prolapse or hysterectomy found that a supervised pelvic floor muscle training program did not significantly improve bladder or prolapse symptoms compared to usual care after 12 months.

The lack of improvement may be attributed to factors such as the effectiveness of the surgery itself, variability in the data, the small sample size, and potential training received by the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiotherapy as an adjunct to prolapse surgery: an assessor-blinded randomized controlled trial. Frawley, HC., Phillips, BA., Bø, K., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11728163/

Physical Exercise Intervention Characteristics and ... Exercise can serve as an effective intervention for pre-frail and frail older adults, improving muscle strength and reducing the risk of falls.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11547147/

The Effect of Exercise Program Interventions on Frailty ... The results demonstrated that multicomponent exercise programs significantly improved frailty status, enhanced physical and cognitive function, and improved ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0197457222002415

The effectiveness of a group-based Otago exercise ... Group-based OEP is helpful for improving physical function, frailty and health status in older nursing home residents.

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03064750

Pelvic Floor Exercise Before Surgery in Women ... This study will investigate whether systematic pelvic floor exercise and life style advise before surgery can improve outcomes after surgery for either vaginal ...

5. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-019-1196-x

What are the most effective interventions to improve physical ... Secondly, interventions combining resistance and balance training were most successful in treating physical symptoms associated with frailty ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2213231720301178

Physical activity and exercise: Strategies to manage frailty Physical activity/exercise is considered one of the main strategies to counteract frailty-related physical impairment in the elderly.