CancerNCT02934230
The Prehabilitation Study: Exercise Before Surgery to Improve Patient Function in People
A study testing Prehabilitation Program in people with Cancer and Frailty, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The rapid aging of the population means that anesthesiologists care for elderly patients with increasing regularity. Although age is an independent predictor for adverse postoperative outcomes, significant outcome variation exists among older surgical patients. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- What is being tested?
- Prehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jan 2017to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years or older
- scheduled to undergo elective surgery for intraabdominal or thoracic cancer
- diagnosed with frailty based on the Clinical Frailty Scale (CFS; score of >4/9 defines frailty)
Who cannot join
- cannot communicate in written or oral form in official languages serviced by TOH (English or French)
- unwilling to participate in home-based prehabilitation
- major cardiac risk factors
- scheduled to undergo surgery in fewer than 3 weeks from randomization
Trial locations and contacts
1 site in 1 country.
About this study
The rapid aging of the population means that anesthesiologists care for elderly patients with increasing regularity. Although age is an independent predictor for adverse postoperative outcomes, significant outcome variation exists among older surgical patients. Frailty, a syndrome that describes an aggregate susceptibility to adverse health outcomes due to age-, and disease-related deficits that accumulate across multiple domains is a key predictor of adverse postoperative outcomes in elderly patients. Frail surgical patients are at increased risk of complications, institutionalization, death, and are high healthcare resource users.
Multiple stakeholders, including anesthesiologists and patients, have identified improving the outcomes of older patients and preoperative exercise training (prehabilitation) as 2 of the 10 most important areas for future perioperative research. Physical vulnerability is an important aspect of the frailty syndrome, and may be amenable to structured exercise therapy. However, the evidence for preoperative exercise training (prehabilitation) improving postoperative outcomes is obscured by methodological limitations and a focus on non-elderly patients. Recently, evidence has emerged that older and sicker patients may benefit most from prehab, however, this hypothesis has not been formally tested.
Read more
Because the complex needs of frail perioperative patients require a longitudinal and multidisciplinary approach, the investigators are developing a perioperative surgical home for the frail elderly (PSH-Frail). Development of the PSH-Frail is supported by a robust data collection system, including linkage of prospectively collected data to health administrative data infrastructure to improve efficiency and long-term follow up.
The investigators hypothesize that prehabilitation will be a vital intervention supported by the PSH frail, however, high quality evidence from randomized trials is needed to support its efficacy. Therefore, the investigators propose a single center randomized controlled trial of prehabilitation of frail elderly patients having elective abdominal and thoracic cancer surgery to improve postoperative function (primary outcome), and to decrease postoperative resource utilization (secondary outcomes).
Read the detailed description
Frailty is a key risk factor for adverse outcomes among the increasingly large number of older patients presenting for surgery. The complexity and risk profile of frail patients makes them a population who may derive significant benefit from the multidisciplinary and continuous care provided by a Perioperative Surgical Home (PSH) model of care. Development of an evidence-based PSH for the frail elderly (PSH-Frail) is the overarching goal of the investigator's research program. However, the PSH-Frail is a complex intervention, and will require high quality evidence to support inclusion of specific processes and interventions into the overall framework.
To date, the investigator's research group has undertaken prospective studies to support the routine and accurate identification of frail patients before surgery. The next step in the development of the PSH-Frail is testing interventions to improve the outcomes of frail elderly surgical patients. The role of preoperative exercise training (prehabilitation) in improving postoperative outcomes is a priority research area in perioperative medicine, and may provide its most significant impact in frail elderly patients. However, this hypothesis has not been formally tested.
Study design:
A single center, parallel arm randomized controlled trial of home-based prehabilitation vs. standard perioperative care in frail elderly patients undergoing elective surgery for intraabdominal cancer will be conducted. This will be a superiority trial to test the hypothesis that home-based prehabilitation will result in improved postoperative functional outcomes compared to standard care. This protocol is described in keeping with the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) guidelines).
Study setting:
This study will be performed at The Ottawa Hospital (TOH), a 900-bed tertiary care academic health sciences center serving a catchment area of 1.2 million people. TOH is the regional cancer referral center for the Eastern portion of the Canadian province of Ontario. On average, cancer patients are seen 4 weeks prior to surgery (as this is a provincial benchmark for cancer care).
Sample size:
To detect a clinically important 25 meter difference in the primary outcome between study arms, using a two-sided test at the 5% level of significance with 80% power, and assuming a standard deviation of 55 meters based on a previously published trial, we will require 77 patients per arm. To account for up to 20% attrition we will enroll 100 patients per arm.
Recruitment:
Patients will be recruited from the investigator's hospital's Cancer Assessment Center. Following cancer diagnosis, patients are seen by a surgeon 4 weeks prior to their scheduled operation. Following surgical assessment and confirmation of the decision to operate, patients who consent to consideration for research contact, and who meet all inclusion criteria except for frailty score, will be assessed by a trained clinician or clinical assistant using the Clinical Frailty Scale (CFS). Patients who score >4/9 on the CFS will then be randomized after providing written informed consent.
Intervention:
The intervention will be a home-based total-body exercise training program (henceforth referred to as prehabilitation) based on a protocol with proven efficacy in improving the function of non-frail surgical patients in less than 4 weeks of preoperative utilization. Prehabilitation will consist of 3 components: 1) strength training; 2) aerobic exercise and 3) flexibility. Prehabilitation will be prescribed as 1-hour sessions performed a minimum of 3 times per week.
Control:
Patients randomized to the control group will be provided standard perioperative care as per institutional standards. Patients will receive the World Health Organization (WHO) Global Recommendations for Physical Activity for Health for people 65 years and above pamphlet, as well as Canada's Food Guide. In-hospital perioperative care, and postoperative care, will be at the discretion of each patient's surgeon and anesthesiologist.
- Being tested
- Prehabilitation Program
- Medical subject headings
- Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation ProgramBehavioural
Strength training: This component consists of 1 set of 10 repetitions of each exercise: a. push-ups (modified to the individual's level of function as either wall push-ups, knee push-ups, or full push-ups); b. seated row (performed with an elastic resistance band); c. chest fly (performed with an elastic resistance band); d. deltoid lift (performed with an elastic resistance band); e. biceps curls (performed with an elastic resistance band); f. triceps extensions (performed with an elastic resistance band); g. chair squats; h. hamstring curls; i. standing calf raises; j. abdominal crunches (modified to be performed seated in a chair)
Aerobics: Walking for 20 minutes at moderate intensity.
Flexibility: Chest, arm, leg and truck stretches, with each stretch to be held for 20 seconds, done for 2 repetitions.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation Group | Experimental | The intervention will be a home-based total-body exercise training program (prehabilitation) based on a protocol with proven efficacy in improving the function of non-frail surgical patients in less than 4 weeks of preoperative utilization.Prehabilitation will consist of 3 components: 1) strength training; 2) aerobic exercise and 3) flexibility. Prehabilitation will be prescribed as 1-hour sessions performed a minimum of 3 times per week. Intervention group patients will also be provided with nutritional advice. In addition to paper-based materials outlining the prehabilitation program, weekly prehabilitation teaching sessions will be held at our Cancer Centre for patients randomized to the intervention group, and activity logs and weekly phone calls will be used to measure compliance and to answer questions. During the final week of the program, patients will also participate in a brief qualitative interview over the phone to explore their experience with the program. Receives: Behavioral: Prehabilitation Program |
| Control Group | No intervention | Patients randomized to the control group will be provided standard perioperative care as per our institutional standards. They will receive the World Health Organization (WHO) Global Recommendations for Physical Activity for Health for people 60 years and above pamphlet, as well as Canada's Food Guide. In-hospital perioperative care, and postoperative care, will be at the discretion of each patient's surgeon and anesthesiologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative functional capacity
Functional capacity at baseline (surgical assessment typically 4 weeks prior to surgery) compared to postoperative functional capacity 30 days after surgery. The primary outcome of this study will be postoperative functional capacity, specifically the 6-minute walk test 30 days after surgery. A clinically relevant difference in this outcome is a change of 25 meters walked over 6 minutes.
Measured: 30 days after surgery
Secondary outcomes (10)
Functional Mobility
Functional outcomes will be assessed using the Short Physical Performance Battery (SPPB).This is a validated, objective assessment, developed by National Institute on Ageing, to evaluate lower extremity functioning in older individuals through assessment of balance, gait speed and lower limb functional strength; each domain is assessed on a 4-point scale, and the overall performance is rated on a cumulative 12-point scale. Participants will complete this at baseline (surgical assessment typically 4 weeks prior to surgery) and at their post-operative surgical follow-up (approximately 30 days after surgery).
Measured: 30 days after surgery
Patient-reported health outcomes and adverse events: Health Related Quality of Life - health state
Measured using the EQ-5D30 (5-level version). The EQ-5D assesses domains of self-perceived mobility, self-care, usual activity participation, pain/discomfort, and anxiety depression which is captured as a overall health state score.
Measured: 30 and 90 days after surgery
Patient-reported health outcomes and adverse events: Health Related Quality of Life
Measured using the EQ-5D30 (5-level version). The EQ-5D also uses a self-report 0-100 point scale relating the person's current health status to their best imaginable status
Measured: 30 and 90 days after surgery
Patient-reported health outcomes and adverse events: Disability Free Survival
Measured using the WHODAS 2.0 instrument, a 30-day look-back multidimensional disability scale that is validated in a variety of disease states, including postoperatively.
Measured: 30 and 90 days after surgery
Patient-reported health outcomes and adverse events: Adverse Events
Based on the National Surgical Quality Improvement Program definitions for medical complications, the type of medical complication will be collected.
Measured: Within 365 days after surgery
Patient-reported health outcomes and adverse events: Adverse Events
Based on the National Surgical Quality Improvement Program definitions for surgical complications, the type of surgical complication will be collected.
Measured: Within 365 days after surgery
Patient-reported health outcomes and adverse events: Adverse Events
The number of participants who experience all-cause mortality will be collected.
Measured: Within 365 days after surgery
Healthcare resource utilization: hospital length of stay
Number of days in hospital post-operatively
Measured: Within 365 days after surgery
Healthcare resource utilization: proportion of patients discharged to an institution, readmissions within 30 days of discharge
Number of patients discharged to an institution and/or re-admitted post-operatively
Measured: Within 365 days after surgery
Healthcare resource utilization: total healthcare costs
Amount of healthcare dollars spent will be generated using a validated algorithm in our administrative data
Measured: Within 365 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study start5 Jan 2017
- Primary completionMar 2020
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel I McIsaac, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934230
- Sponsor's protocol ID
- 20160091
- Status last verified
- Jun 2020
- First submitted
- 22 Aug 2016
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
McIsaac DI, Neilipovitz N, Bryson GL, Gagne S, Huang A, Lalu M, Lavallee LT, Moloo H, Power B, Scheede-Bergdahl C, van Walraven C, McCartney CJL, Taljaard M, Hladkowicz E. Home-based exercise prehabilitation to improve disease-free survival and return to intended oncologic treatment after cancer surgery in older adults with frailty: a secondary analysis of a randomized trial. Can J Anaesth. 2024 Nov;71(11):1525-1534. doi: 10.1007/s12630-024-02835-w. Epub 2024 Sep 5.
PubMed 39237725McIsaac DI, Hladkowicz E, Bryson GL, Forster AJ, Gagne S, Huang A, Lalu M, Lavallee LT, Moloo H, Nantel J, Power B, Scheede-Bergdahl C, van Walraven C, McCartney CJL, Taljaard M. Home-based prehabilitation with exercise to improve postoperative recovery for older adults with frailty having cancer surgery: the PREHAB randomised clinical trial. Br J Anaesth. 2022 Jul;129(1):41-48. doi: 10.1016/j.bja.2022.04.006. Epub 2022 May 17.
PubMed 35589429McIsaac DI, Saunders C, Hladkowicz E, Bryson GL, Forster AJ, Gagne S, Huang A, Lalu M, Lavallee LT, Moloo H, Nantel J, Power B, Scheede-Bergdahl C, Taljaard M, van Walraven C, McCartney CJL. PREHAB study: a protocol for a prospective randomised clinical trial of exercise therapy for people living with frailty having cancer surgery. BMJ Open. 2018 Jun 22;8(6):e022057. doi: 10.1136/bmjopen-2018-022057.
PubMed 29934394
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prehabilitation Study: Exercise Before Surgery to Improve Patient Function in People
- ClinicalTrials.gov ID
- NCT02934230
- Acronym / sponsor ID
- 20160091
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2021 (estimated)
- First posted
- 14 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rapid aging of the population means that anesthesiologists care for elderly patients with increasing regularity. Although age is an independent predictor for adverse postoperative outcomes, significant outcome variation exists among older surgical patients. Frailty, a syndrome that describes an aggregate susceptibility to adverse health outcomes due to age-, and disease-related deficits that accumulate across multiple domains is a key predictor of adverse postoperative outcomes in elderly patients. Frail surgical patients are at increased risk of complications, institutionalization, death, and are high healthcare resource users.
Multiple stakeholders, including anesthesiologists and patients, have identified improving the outcomes of older patients and preoperative exercise training (prehabilitation) as 2 of the 10 most important areas for future perioperative research. Physical vulnerability is an important aspect of the frailty syndrome, and may be amenable to structured exercise therapy. However, the evidence for preoperative exercise training (prehabilitation) improving postoperative outcomes is obscured by methodological limitations and a focus on non-elderly patients. Recently, evidence has emerged that older and sicker patients may benefit most from prehab, however, this hypothesis has not been formally tested.
Because the complex needs of frail perioperative patients require a longitudinal and multidisciplinary approach, the investigators are developing a perioperative surgical home for the frail elderly (PSH-Frail). Development of the PSH-Frail is supported by a robust data collection system, including linkage of prospectively collected data to health administrative data infrastructure to improve efficiency and long-term follow up.
The investigators hypothesize that prehabilitation will be a vital intervention supported by the PSH frail, however, high quality evidence from randomized trials is needed to support its efficacy. Therefore, the investigators propose a single center randomized controlled trial of prehabilitation of frail elderly patients having elective abdominal and thoracic cancer surgery to improve postoperative function (primary outcome), and to decrease postoperative resource utilization (secondary outcomes).
Detailed description
Frailty is a key risk factor for adverse outcomes among the increasingly large number of older patients presenting for surgery. The complexity and risk profile of frail patients makes them a population who may derive significant benefit from the multidisciplinary and continuous care provided by a Perioperative Surgical Home (PSH) model of care. Development of an evidence-based PSH for the frail elderly (PSH-Frail) is the overarching goal of the investigator's research program. However, the PSH-Frail is a complex intervention, and will require high quality evidence to support inclusion of specific processes and interventions into the overall framework.
To date, the investigator's research group has undertaken prospective studies to support the routine and accurate identification of frail patients before surgery. The next step in the development of the PSH-Frail is testing interventions to improve the outcomes of frail elderly surgical patients. The role of preoperative exercise training (prehabilitation) in improving postoperative outcomes is a priority research area in perioperative medicine, and may provide its most significant impact in frail elderly patients. However, this hypothesis has not been formally tested.
Study design:
A single center, parallel arm randomized controlled trial of home-based prehabilitation vs. standard perioperative care in frail elderly patients undergoing elective surgery for intraabdominal cancer will be conducted. This will be a superiority trial to test the hypothesis that home-based prehabilitation will result in improved postoperative functional outcomes compared to standard care. This protocol is described in keeping with the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) guidelines).
Study setting:
This study will be performed at The Ottawa Hospital (TOH), a 900-bed tertiary care academic health sciences center serving a catchment area of 1.2 million people. TOH is the regional cancer referral center for the Eastern portion of the Canadian province of Ontario. On average, cancer patients are seen 4 weeks prior to surgery (as this is a provincial benchmark for cancer care).
Sample size:
To detect a clinically important 25 meter difference in the primary outcome between study arms, using a two-sided test at the 5% level of significance with 80% power, and assuming a standard deviation of 55 meters based on a previously published trial, we will require 77 patients per arm. To account for up to 20% attrition we will enroll 100 patients per arm.
Recruitment:
Patients will be recruited from the investigator's hospital's Cancer Assessment Center. Following cancer diagnosis, patients are seen by a surgeon 4 weeks prior to their scheduled operation. Following surgical assessment and confirmation of the decision to operate, patients who consent to consideration for research contact, and who meet all inclusion criteria except for frailty score, will be assessed by a trained clinician or clinical assistant using the Clinical Frailty Scale (CFS). Patients who score >4/9 on the CFS will then be randomized after providing written informed consent.
Intervention:
The intervention will be a home-based total-body exercise training program (henceforth referred to as prehabilitation) based on a protocol with proven efficacy in improving the function of non-frail surgical patients in less than 4 weeks of preoperative utilization. Prehabilitation will consist of 3 components: 1) strength training; 2) aerobic exercise and 3) flexibility. Prehabilitation will be prescribed as 1-hour sessions performed a minimum of 3 times per week.
Control:
Patients randomized to the control group will be provided standard perioperative care as per institutional standards. Patients will receive the World Health Organization (WHO) Global Recommendations for Physical Activity for Health for people 65 years and above pamphlet, as well as Canada's Food Guide. In-hospital perioperative care, and postoperative care, will be at the discretion of each patient's surgeon and anesthesiologist.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation Group | Experimental | Behavioral: Prehabilitation ProgramThe intervention will be a home-based total-body exercise training program (prehabilitation) based on a protocol with proven efficacy in improving the function of non-frail surgical patients in less than 4 weeks of preoperative utilization.Prehabilitation will consist of 3 components: 1) strength training; 2) aerobic exercise and 3) flexibility. Prehabilitation will be prescribed as 1-hour sessions performed a minimum of 3 times per week. Intervention group patients will also be provided with nutritional advice. In addition to paper-based materials outlining the prehabilitation program, weekly prehabilitation teaching sessions will be held at our Cancer Centre for patients randomized to the intervention group, and activity logs and weekly phone calls will be used to measure compliance and to answer questions. During the final week of the program, patients will also participate in a brief qualitative interview over the phone to explore their experience with the program. |
| Control Group | No intervention | –Patients randomized to the control group will be provided standard perioperative care as per our institutional standards. They will receive the World Health Organization (WHO) Global Recommendations for Physical Activity for Health for people 60 years and above pamphlet, as well as Canada's Food Guide. In-hospital perioperative care, and postoperative care, will be at the discretion of each patient's surgeon and anesthesiologist. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60 years or older
- scheduled to undergo elective surgery for intraabdominal or thoracic cancer
- diagnosed with frailty based on the Clinical Frailty Scale (CFS; score of >4/9 defines frailty)
Key exclusion criteria (4 listed)
- cannot communicate in written or oral form in official languages serviced by TOH (English or French)
- unwilling to participate in home-based prehabilitation
- major cardiac risk factors
- scheduled to undergo surgery in fewer than 3 weeks from randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation ProgramStrength training: This component consists of 1 set of 10 repetitions of each exercise: a. push-ups (modified to the individual's level of function as either wall push-ups, knee push-ups, or full push-ups); b. seated row (performed with an elastic resistance band); c. chest fly (performed with an elastic resistance band); d. deltoid lift (performed with an elastic resistance band); e. biceps curls (performed with an elastic resistance band); f. triceps extensions (performed with an elastic resistance band); g. chair squats; h. hamstring curls; i. standing calf raises; j. abdominal crunches (modified to be performed seated in a chair) Aerobics: Walking for 20 minutes at moderate intensity. Flexibility: Chest, arm, leg and truck stretches, with each stretch to be held for 20 seconds, done for 2 repetitions. | Behavioural | Prehabilitation Group |
Primary outcome
Postoperative functional capacity
Time frame: 30 days after surgery
Functional capacity at baseline (surgical assessment typically 4 weeks prior to surgery) compared to postoperative functional capacity 30 days after surgery. The primary outcome of this study will be postoperative functional capacity, specifically the 6-minute walk test 30 days after surgery. A clinically relevant difference in this outcome is a change of 25 meters walked over 6 minutes.
10 secondary outcomes
Functional Mobility
Time frame: 30 days after surgery
Patient-reported health outcomes and adverse events: Health Related Quality of Life - health state
Time frame: 30 and 90 days after surgery
Patient-reported health outcomes and adverse events: Health Related Quality of Life
Time frame: 30 and 90 days after surgery
Patient-reported health outcomes and adverse events: Disability Free Survival
Time frame: 30 and 90 days after surgery
Patient-reported health outcomes and adverse events: Adverse Events
Time frame: Within 365 days after surgery
Patient-reported health outcomes and adverse events: Adverse Events
Time frame: Within 365 days after surgery
Patient-reported health outcomes and adverse events: Adverse Events
Time frame: Within 365 days after surgery
Healthcare resource utilization: hospital length of stay
Time frame: Within 365 days after surgery
Healthcare resource utilization: proportion of patients discharged to an institution, readmissions within 30 days of discharge
Time frame: Within 365 days after surgery
Healthcare resource utilization: total healthcare costs
Time frame: Within 365 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Derived from this study: PubMed 39237725McIsaac DI, Neilipovitz N, Bryson GL, Gagne S, Huang A, Lalu M, Lavallee LT, Moloo H, Power B, Scheede-Bergdahl C, van Walraven C, McCartney CJL, Taljaard M, Hladkowicz E. Home-based exercise prehabilitation to improve disease-free survival and return to intended oncologic treatment after cancer surgery in older adults with frailty: a secondary analysis of a randomized trial. Can J Anaesth. 2024 Nov;71(11):1525-1534. doi: 10.1007/s12630-024-02835-w. Epub 2024 Sep 5.
- Derived from this study: PubMed 35589429McIsaac DI, Hladkowicz E, Bryson GL, Forster AJ, Gagne S, Huang A, Lalu M, Lavallee LT, Moloo H, Nantel J, Power B, Scheede-Bergdahl C, van Walraven C, McCartney CJL, Taljaard M. Home-based prehabilitation with exercise to improve postoperative recovery for older adults with frailty having cancer surgery: the PREHAB randomised clinical trial. Br J Anaesth. 2022 Jul;129(1):41-48. doi: 10.1016/j.bja.2022.04.006. Epub 2022 May 17.
- Derived from this study: PubMed 29934394McIsaac DI, Saunders C, Hladkowicz E, Bryson GL, Forster AJ, Gagne S, Huang A, Lalu M, Lavallee LT, Moloo H, Nantel J, Power B, Scheede-Bergdahl C, Taljaard M, van Walraven C, McCartney CJL. PREHAB study: a protocol for a prospective randomised clinical trial of exercise therapy for people living with frailty having cancer surgery. BMJ Open. 2018 Jun 22;8(6):e022057. doi: 10.1136/bmjopen-2018-022057.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel I McIsaac, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation Program in people with Cancer and Frailty, run by Ottawa Hospital Research Institute 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative functional capacity (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02934230, which also lists 3 linked publications.
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 9 Jun 2020.