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

850 Participants Needed

Trial Summary

What is the purpose of this trial?

This study evaluates whether participating in a home-based exercise program leads to lower levels of complication rates and patient-reported disability after surgery. Half of the participants will be randomized into the exercise group, while the other half will be randomized into the control group.

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 data supports the effectiveness of the treatment Pre-Surgery Exercise for Frailty?

Research shows that exercise prehabilitation (pre-surgery exercise) can improve recovery and outcomes for frail older adults undergoing surgery, as it helps increase their physical reserves and reduce recovery time. ^{1 2 3 4 5}

Is pre-surgery exercise safe for people with frailty?

Exercise, including pelvic floor exercises and physical therapy, is generally safe for humans and can improve outcomes, especially when supervised by qualified health professionals. Studies show benefits in various conditions, such as urinary incontinence and pelvic floor dysfunction, with no significant safety concerns reported. ^{2 6 7 8 9}

How is the pre-surgery exercise treatment for frailty different from other treatments?

This treatment is unique because it focuses on exercise prehabilitation, which aims to improve physical function and resilience before surgery, particularly for frail older adults undergoing cancer surgery. Unlike standard treatments, it includes a combination of physical therapy, pelvic floor exercises, Kegel exercises, and balance and strength training, which are tailored to enhance recovery and reduce postoperative complications. ^{2 3 4 10 11}

Research Team

Daniel I McIsaac, MD,MPH,FRCPC

Principal Investigator

The Ottawa Hospital Research Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Physiotherapy as an adjunct to prolapse surgery: an assessor-blinded randomized controlled trial. [2022]

2. England 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. [2022]

3. England 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Protocol for a single-centre, randomised controlled study of a preoperative rehabilitation bundle in the frail and elderly undergoing abdominal surgery. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Frailty, cognitive impairment, and functional disability in older women with female pelvic floor dysfunction. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training is better than hypopressive exercises in pelvic organ prolapse treatment: An assessor-blinded randomized controlled trial. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Pelvic floor muscle training, the risk of falls and urgency urinary incontinence in older women. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Community-based Pelvic Floor Muscle Training to Improve Pelvic Floor Dysfunction in Chinese Perimenopausal Women: A Randomized Controlled Trial. [2021]

9. Ireland pubmed.ncbi.nlm.nih.gov

Pelvic floor exercise for urinary incontinence: a systematic literature review. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

[Prehabilitation, Well Prepared for Abdominal Surgery]. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Fit4SurgeryTV At-home Prehabilitation for Frail Older Patients Planned for Colorectal Cancer Surgery: A Pilot Study. [2020]