Trial Outcomes & Findings for Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery. (NCT NCT02219815)

Results Overview

Proportion of patients with hospital length of stay greater than 7 days compared to those with less than 7 days

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

89 participants

Primary outcome timeframe

Post-surgery (approximately 9 weeks after baseline)

Results posted on

2024-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Care Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Prehab Intervention Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Overall Study STARTED	44	45
Overall Study Post Hospital Discharge Analysis	42	39
Overall Study 3 Month Post Surgery	34	31
Overall Study COMPLETED	22	21
Overall Study NOT COMPLETED	22	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Care n=42 Participants Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Prehab Intervention n=39 Participants Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.	Total n=81 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=42 Participants	0 Participants n=39 Participants	0 Participants n=81 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=42 Participants	4 Participants n=39 Participants	15 Participants n=81 Participants
Age, Categorical >=65 years	31 Participants n=42 Participants	35 Participants n=39 Participants	66 Participants n=81 Participants
Age, Continuous	69.3 years STANDARD_DEVIATION 5.2 • n=42 Participants	71.4 years STANDARD_DEVIATION 6.4 • n=39 Participants	70.3 years STANDARD_DEVIATION 5.9 • n=81 Participants
Sex: Female, Male Female	11 Participants n=42 Participants	5 Participants n=39 Participants	16 Participants n=81 Participants
Sex: Female, Male Male	31 Participants n=42 Participants	34 Participants n=39 Participants	65 Participants n=81 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	42 participants n=42 Participants	39 participants n=39 Participants	81 participants n=81 Participants

PRIMARY outcome

Timeframe: Post-surgery (approximately 9 weeks after baseline)

Proportion of patients with hospital length of stay greater than 7 days compared to those with less than 7 days

Outcome measures

Outcome measures
Measure	Standard Care n=42 Participants Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Prehab Intervention n=39 Participants Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Proportion of Patients With Hospital Length of Stay Greater Than 7 Days.	20 Participants	16 Participants

SECONDARY outcome

Timeframe: baseline assessment - Study entry

This measure will be assessed using the results of a 6 minute walk test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-Surgery (approximately 8 weeks after baseline)

This measure will be assessed using the results of a 6 minute walk test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 Months Post-Surgery (approximately 5 months after baseline)

This measure will be assessed using the results of a 6 minute walk test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 Year Post-Surgery (approximately 14 months after baseline)

This measure will be assessed using the results of a 6 minute walk test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline assessment - Study entry

This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-Surgery (approximately 8 weeks after baseline)

This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 Months Post-Surgery (approximately 5 months after baseline)

This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 Year Post-Surgery (approximately 14 months after baseline)

This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline assessment - Study entry

This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-Surgery (approximately 8 weeks after baseline)

This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 Months Post-Surgery (approximately 5 months after baseline)

This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 Year Post-Surgery (approximately 14 months after baseline)

This measure will be assessed using EuroQual-Visual Analogue Scale. (EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline assessment - Study entry

This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-Surgery (approximately 8 weeks after baseline)

This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 Months Post-Surgery (approximately 5 months after baseline)

This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 Year Post-Surgery (approximately 14 months after baseline)

This measure will be assessed using the Modified Fried Criteria Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline Assessment - Study entry

This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-Surgery Assessment (approximately 8 weeks after baseline)

This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 Months Post-Surgery (approximately 5 months after baseline)

This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 Year Post-Surgery (approximately 14 months after baseline)

This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points. The higher the score the more symptoms of anxiety may be observed

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline Assessment - Study entry

This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-surgery Assessment ( 8 weeks after baseline)

This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 Months Post-Surgery (approximately 5 months after baseline)

This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year Post-Surgery (approximately 14 months after baseline)

This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5. A score of 2 or more may indicated symptoms of depression

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post-Surgery (approximately 9 weeks after baseline)

Major adverse events include death, myocardial infarction (MI), stroke or renal failure requiring dialysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post-Surgery (approximately 20 weeks after baseline)

Will be assessed using administrative data from participating cardiac rehabilitation facilities.

Outcome measures

Outcome data not reported

Adverse Events

Standard Care

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Prehab Intervention

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard Care n=42 participants at risk Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Prehab Intervention n=39 participants at risk Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Vascular disorders Stroke	4.8% 2/42 • Number of events 2 • 12 months	2.6% 1/39 • Number of events 1 • 12 months

Other adverse events

Other adverse events
Measure	Standard Care n=42 participants at risk Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site. At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery. At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist. In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g. smoking cessation, diet, exercise).	Prehab Intervention n=39 participants at risk Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care. Prehab Intervention: Pre-operative, structured exercise intervention.
Nervous system disorders post operative Delirium	19.0% 8/42 • Number of events 8 • 12 months	7.7% 3/39 • Number of events 3 • 12 months

Additional Information

Dr. Rakesh Arora

St. Boniface Hospital

Phone: 2042581078

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place