FrailtyNCT05977556
Perioperative Prehabilitation on Markers of Fitness and Frailty in Patients Undergoing Elective Surgery
A study testing Combined neuromuscular exercise training and 'sit less, move more' program in people with Frailty, run by University of Alberta at 1 site in Canada.
Trial summary
A growing body of evidence suggests that patients who receive good perioperative care (i.e. care prior to surgery, during surgery, and after surgery) tend to have fewer complications, quicker recovery times, and shorter hospital stays. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Combined neuromuscular exercise training and 'sit less, move more' program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 21 Sep 2026to Jun 2028
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 years of age or older
- score of 4-6 (vulnerable, mildly or moderately frail) on the clinical frailty scale (CFS)
- scheduled for elective surgery
- ambulatory (indoor and/or outdoor) with or without gait aids
Who cannot join
- Unstable medical conditions that limit exercise tolerance such as ME/CFS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Perioperative Prehabilitation on Markers of Fitness and Frailty in Patients Undergoing Elective Surgery: a Pilot, Pragmatic, Randomized Controlled Trial
A growing body of evidence suggests that patients who receive good perioperative care (i.e. care prior to surgery, during surgery, and after surgery) tend to have fewer complications, quicker recovery times, and shorter hospital stays. A key component of good perioperative care is recognizing individuals who have diminished physiological reserves (i.e. those who are vulnerable or frail). The stress of an invasive procedure can exhaust the diminished reserves of patients who are frail, which can in turn lead to perioperative complications, mortality and an increase burden to the healthcare system.
Early interventions in patients with diminished reserves can be applied to reduce the risk of complications and poor outcomes. There are emerging studies that show promising benefits of perioperative interventions, such as prehabilitation, though with some mixed findings. Exercise has been shown to reverse or modify the molecular driving factors of frailty, which involve dysregulation of cytokine and endocrine pathways.
Physical inactivity and prolonged sedentary behaviors are also emerging concerns in frailty because of the implicated deleterious health effects. Sedentary behaviors are associated with prevalence and severity of frailty. Among pre-frail and frail inactive adults, sedentary time is associated with higher mortality. Increasing physical activity is recommended as the most feasible approach to prevent and treat frailty. The aim of this study is to determine if a prehabilitation intervention that combines neuromuscular strength training and intervention to reduce sedentary behavior reduces complications, length of stay, and patient recovery, thereby also reducing the burden on the healthcare system.
Read the detailed description
Frailty is a complex syndrome associated with poor health outcomes in adults, independent of chronological age. Early identification and management of frailty can help improve outcomes and quality of life. Physical activity and exercise interventions, including strength training, have been recommended to manage frailty. Prehabilitation, a preventive intervention before a process of care, has shown promise but with mixed findings. Weight/resistance/strength training and reducing sedentary behavior are important components in frailty management. Sedentary behavior is associated with higher mortality in frail adults. Increasing physical activity may be helpful in preventing and treating frailty. We aim to test a prehabilitation program combining neuromuscular exercise and sedentary behavior intervention in frail adults undergoing elective surgery.
Objective: To evaluate the effect of a 12-week prehabilitation program that combines muscular strengthening exercise with reducing sedentary behaviour for patients 50 years of age or older with frailty undergoing elective surgery.
Hypothesis: The main hypothesis is that the combined prehabilitation program will improve postoperative recovery and reduce the risk of adverse outcomes following elective surgery by improving frailty levels.
Methods: Fifty adults who are vulnerable, mildly, or moderately frail score of 4-6 on the Clinical Frailty Scale (CFS) will be randomly assigned to either the experimental (n=25) or control (n=25) group. The experimental group will receive up to 24 sessions of neuromuscular strength training delivered twice a week over a 12-week period combined with an intervention to reduce and frequently interrupt sedentary behavior. The control group will receive standard of care that is provided as part of the perioperative surgical procedure and subsequent rehabilitation. The "usual care" comparator arm appears to be an appropriate option for a pilot pragmatic study.
- Conditions
- Frailty
- Being tested
- Combined neuromuscular exercise training and 'sit less, move more' program
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined neuromuscular exercise training and 'sit less, move more' programBehavioural
Neuromuscular strength training: The experimental group will receive up to 24 sessions of neuromuscular strength training led by a physical therapist with expertise in geriatrics and movement behaviors. The program includes exercises such as pelvic lifts, lunges, step-ups, squats, and sit-stands. The difficulty level will progressively increase using techniques like manual resistance, dumbbells, and unstable surfaces.
Sedentary behavior intervention: The experimental group will also undergo a sedentary behavior intervention based on social cognitive theory. It involves weekly coaching sessions to enhance self-efficacy in reducing sedentary time and increasing light-intensity activity throughout the day. Participants will be provided with a wrist-worn Fitbit activity monitor for daily feedback and to track adherence to the intervention. The aim is to encourage participants to "sit less and move more" throughout their waking hours.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Neuromuscular strength training: The experimental group will receive up to 24 sessions of neuromuscular strength training led by a physical therapist with expertise in geriatrics and movement behaviors. The program includes exercises such as pelvic lifts, lunges, step-ups, squats, and sit-stands. The difficulty level will progressively increase using techniques like manual resistance, dumbbells, and unstable surfaces.
Sedentary behavior intervention: The experimental group will also undergo a sedentary behavior intervention based on social cognitive theory. It involves weekly coaching sessions to enhance self-efficacy in reducing sedentary time and increasing light-intensity activity throughout the day. Participants will be provided with a wrist-worn Fitbit activity monitor for daily feedback and to track adherence to the intervention. The aim is to encourage participants to "sit less and move more" throughout their waking hours. Receives: Behavioral: Combined neuromuscular exercise training and 'sit less, move more' program |
| Standard of care | No intervention | The control group will receive standard of care that is provided as part of the perioperative surgical procedure and subsequent rehabilitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline gait speed at 12 and 24 weeks
Comfortable walking speed will be assessed over a 5-meter walkway
Measured: 12 and 24 weeks
Secondary outcomes (11)
Change from baseline physical activity at 12 and 24 weeks
Activpal-derived time spent per day in physical activity
Measured: 12 and 24 weeks
Change from baseline sedentary behavior at 12 and 24 weeks
Activpal-derived time spent per day in sedentary behavior
Measured: 12 and 24 weeks
Change from baseline sleep at 12 and 24 weeks
Activpal-derived time spent per day in sleep
Measured: 12 and 24 weeks
Change from baseline Timed-Up and Go (TUG) test at 12 and 24 weeks
Functional mobility will be assessed using the TUG test
Measured: 12 and 24 weeks
Change from baseline functional lower extremity strength at 12 and 24 weeks
Lower extremity strength will be measured using the 30 seconds sit-stand test
Measured: 12 and 24 weeks
Change from baseline hand grip strength at 12 and 24 weeks
Grip strength will be assessed using a dynamometer
Measured: 12 and 24 weeks
Change from baseline Barthel Index at 12 and 24 weeks
Level of independence in activities of daily living (ADL) will be assessed using Barthel Index
Measured: 12 and 24 weeks
Length of hospital stay after surgery to be determined at 12 and 24 weeks
We will determine the length of stay in the hospital
Measured: 12 and 24 weeks
Readmission rate to hospital after discharge to be determined at 12 and 24 weeks
We will determine the hospital readmissions rate within 30 days of discharge.
Measured: 12 and 24 weeks
Change from baseline Saint Louis University mental status (SLUMS) test
Cognitive assessment will be completed using the SLUMS test
Measured: 12 and 24 weeks
Number of participants with reported postoperative complications
We will determine the number of participants with postoperative complications
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start21 Sep 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Alexandra Hospital
- Responsible party
- Sponsor
- Investigators
- Naheed Rajabali, MD, Principal investigator, Alberta Health servicesVictor Ezeugwu, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977556
- Sponsor's protocol ID
- Pro00122843
- Status last verified
- Sep 2026
- First submitted
- 18 Jul 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative Prehabilitation on Markers of Fitness and Frailty in Patients Undergoing Elective Surgery: a Pilot, Pragmatic, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05977556
- Acronym / sponsor ID
- Pro00122843
- Conditions
- Frailty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Royal Alexandra Hospital
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 4 Aug 2023 (actual)
- 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.
A growing body of evidence suggests that patients who receive good perioperative care (i.e. care prior to surgery, during surgery, and after surgery) tend to have fewer complications, quicker recovery times, and shorter hospital stays. A key component of good perioperative care is recognizing individuals who have diminished physiological reserves (i.e. those who are vulnerable or frail). The stress of an invasive procedure can exhaust the diminished reserves of patients who are frail, which can in turn lead to perioperative complications, mortality and an increase burden to the healthcare system.
Early interventions in patients with diminished reserves can be applied to reduce the risk of complications and poor outcomes. There are emerging studies that show promising benefits of perioperative interventions, such as prehabilitation, though with some mixed findings. Exercise has been shown to reverse or modify the molecular driving factors of frailty, which involve dysregulation of cytokine and endocrine pathways.
Physical inactivity and prolonged sedentary behaviors are also emerging concerns in frailty because of the implicated deleterious health effects. Sedentary behaviors are associated with prevalence and severity of frailty. Among pre-frail and frail inactive adults, sedentary time is associated with higher mortality. Increasing physical activity is recommended as the most feasible approach to prevent and treat frailty. The aim of this study is to determine if a prehabilitation intervention that combines neuromuscular strength training and intervention to reduce sedentary behavior reduces complications, length of stay, and patient recovery, thereby also reducing the burden on the healthcare system.
Detailed description
Frailty is a complex syndrome associated with poor health outcomes in adults, independent of chronological age. Early identification and management of frailty can help improve outcomes and quality of life. Physical activity and exercise interventions, including strength training, have been recommended to manage frailty. Prehabilitation, a preventive intervention before a process of care, has shown promise but with mixed findings. Weight/resistance/strength training and reducing sedentary behavior are important components in frailty management. Sedentary behavior is associated with higher mortality in frail adults. Increasing physical activity may be helpful in preventing and treating frailty. We aim to test a prehabilitation program combining neuromuscular exercise and sedentary behavior intervention in frail adults undergoing elective surgery.
Objective: To evaluate the effect of a 12-week prehabilitation program that combines muscular strengthening exercise with reducing sedentary behaviour for patients 50 years of age or older with frailty undergoing elective surgery.
Hypothesis: The main hypothesis is that the combined prehabilitation program will improve postoperative recovery and reduce the risk of adverse outcomes following elective surgery by improving frailty levels.
Methods: Fifty adults who are vulnerable, mildly, or moderately frail score of 4-6 on the Clinical Frailty Scale (CFS) will be randomly assigned to either the experimental (n=25) or control (n=25) group. The experimental group will receive up to 24 sessions of neuromuscular strength training delivered twice a week over a 12-week period combined with an intervention to reduce and frequently interrupt sedentary behavior. The control group will receive standard of care that is provided as part of the perioperative surgical procedure and subsequent rehabilitation. The "usual care" comparator arm appears to be an appropriate option for a pilot pragmatic study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Combined neuromuscular exercise training and 'sit less, move more' programNeuromuscular strength training: The experimental group will receive up to 24 sessions of neuromuscular strength training led by a physical therapist with expertise in geriatrics and movement behaviors. The program includes exercises such as pelvic lifts, lunges, step-ups, squats, and sit-stands. The difficulty level will progressively increase using techniques like manual resistance, dumbbells, and unstable surfaces. Sedentary behavior intervention: The experimental group will also undergo a sedentary behavior intervention based on social cognitive theory. It involves weekly coaching sessions to enhance self-efficacy in reducing sedentary time and increasing light-intensity activity throughout the day. Participants will be provided with a wrist-worn Fitbit activity monitor for daily feedback and to track adherence to the intervention. The aim is to encourage participants to "sit less and move more" throughout their waking hours. |
| Standard of care | No intervention | –The control group will receive standard of care that is provided as part of the perioperative surgical procedure and subsequent rehabilitation. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 50 years of age or older
- score of 4-6 (vulnerable, mildly or moderately frail) on the clinical frailty scale (CFS)
- scheduled for elective surgery
- ambulatory (indoor and/or outdoor) with or without gait aids
Key exclusion criteria (1 listed)
- Unstable medical conditions that limit exercise tolerance such as ME/CFS
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 |
|---|---|---|
| Combined neuromuscular exercise training and 'sit less, move more' programNeuromuscular strength training: The experimental group will receive up to 24 sessions of neuromuscular strength training led by a physical therapist with expertise in geriatrics and movement behaviors. The program includes exercises such as pelvic lifts, lunges, step-ups, squats, and sit-stands. The difficulty level will progressively increase using techniques like manual resistance, dumbbells, and unstable surfaces. Sedentary behavior intervention: The experimental group will also undergo a sedentary behavior intervention based on social cognitive theory. It involves weekly coaching sessions to enhance self-efficacy in reducing sedentary time and increasing light-intensity activity throughout the day. Participants will be provided with a wrist-worn Fitbit activity monitor for daily feedback and to track adherence to the intervention. The aim is to encourage participants to "sit less and move more" throughout their waking hours. | Behavioural | Experimental |
Primary outcome
Change from baseline gait speed at 12 and 24 weeks
Time frame: 12 and 24 weeks
Comfortable walking speed will be assessed over a 5-meter walkway
11 secondary outcomes
Change from baseline physical activity at 12 and 24 weeks
Time frame: 12 and 24 weeks
Change from baseline sedentary behavior at 12 and 24 weeks
Time frame: 12 and 24 weeks
Change from baseline sleep at 12 and 24 weeks
Time frame: 12 and 24 weeks
Change from baseline Timed-Up and Go (TUG) test at 12 and 24 weeks
Time frame: 12 and 24 weeks
Change from baseline functional lower extremity strength at 12 and 24 weeks
Time frame: 12 and 24 weeks
Change from baseline hand grip strength at 12 and 24 weeks
Time frame: 12 and 24 weeks
Change from baseline Barthel Index at 12 and 24 weeks
Time frame: 12 and 24 weeks
Length of hospital stay after surgery to be determined at 12 and 24 weeks
Time frame: 12 and 24 weeks
Readmission rate to hospital after discharge to be determined at 12 and 24 weeks
Time frame: 12 and 24 weeks
Change from baseline Saint Louis University mental status (SLUMS) test
Time frame: 12 and 24 weeks
Number of participants with reported postoperative complications
Time frame: 12 and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- 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.
Naheed Rajabali, MD principal investigator
Alberta Health services
Victor Ezeugwu, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined neuromuscular exercise training and 'sit less, move more' program in people with Frailty, run by University of Alberta 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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 10 Sep 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 Victor E. Ezeugwu, PhD (7804925108, ezeugwu@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline gait speed at 12 and 24 weeks (time frame: 12 and 24 weeks). 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 10 Sep 2026.