Trial Outcomes & Findings for Cardiac Rehabilitation for Heart Event Recovery (HER) (NCT NCT01019135)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

169 participants

Primary outcome timeframe

6 months

Results posted on

2015-11-30

Participant Flow

Participant milestones

Participant milestones
Measure	Women-Only Cardiac Rehabilitation Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models	Co-ed Cardiac Rehabilitation Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models	Home-Based Cardiac Rehabilitation Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
Overall Study STARTED	55	59	55
Overall Study COMPLETED	35	40	24
Overall Study NOT COMPLETED	20	19	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Women-Only Cardiac Rehabilitation Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models	Co-ed Cardiac Rehabilitation Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models	Home-Based Cardiac Rehabilitation Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
Overall Study Did not receive allocated intervention	12	6	25
Overall Study Did not attend CR	8	13	6

Baseline Characteristics

Cardiac Rehabilitation for Heart Event Recovery (HER)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Women-Only Cardiac Rehabilitation n=55 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models	Co-ed Cardiac Rehabilitation n=59 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models	Home-Based Cardiac Rehabilitation n=55 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models	Total n=169 Participants Total of all reporting groups
Age, Continuous	66.22 years STANDARD_DEVIATION 10.21 • n=5 Participants	61.56 years STANDARD_DEVIATION 9.73 • n=7 Participants	63.13 years STANDARD_DEVIATION 10.94 • n=5 Participants	63.64 years STANDARD_DEVIATION 10.42 • n=4 Participants
Sex/Gender, Customized Females	55 participants n=5 Participants	59 participants n=7 Participants	55 participants n=5 Participants	169 participants n=4 Participants
Race/Ethnicity, Customized White	26 participants n=5 Participants	32 participants n=7 Participants	32 participants n=5 Participants	90 participants n=4 Participants
Race/Ethnicity, Customized Other	29 participants n=5 Participants	27 participants n=7 Participants	23 participants n=5 Participants	79 participants n=4 Participants
Region of Enrollment Canada	55 participants n=5 Participants	59 participants n=7 Participants	55 participants n=5 Participants	169 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Participants with available data for adherence

Outcome measures

Outcome measures
Measure	Women-Only Cardiac Rehabilitation n=54 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models	Co-ed Cardiac Rehabilitation n=53 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models	Home-Based Cardiac Rehabilitation n=46 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
CR Program Adherence	54.40 percentage of sessions attended Standard Deviation 34.72	51.33 percentage of sessions attended Standard Deviation 35.7	58.12 percentage of sessions attended Standard Deviation 35.39

SECONDARY outcome

Timeframe: 6 months

Population: Participants with available data for exercise capacity

Exercise capacity as measured by VO2peak on a graded stress test.

Outcome measures

Outcome measures
Measure	Women-Only Cardiac Rehabilitation n=28 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models	Co-ed Cardiac Rehabilitation n=30 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models	Home-Based Cardiac Rehabilitation n=32 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
Exercise Capacity	21.6071 mL/(kg·min) Standard Deviation 7.18327	20.8450 mL/(kg·min) Standard Deviation 6.51039	21.0734 mL/(kg·min) Standard Deviation 8.99184

SECONDARY outcome

Timeframe: 6 months

Population: Participants with available data for exercise

Mean daily steps as measured by a pedometer over 7 days

Outcome measures

Outcome measures
Measure	Women-Only Cardiac Rehabilitation n=21 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models	Co-ed Cardiac Rehabilitation n=15 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models	Home-Based Cardiac Rehabilitation n=19 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
Exercise	5296.9660 Daily steps Standard Deviation 2803.16268	6129.7143 Daily steps Standard Deviation 3107.17927	6694.3308 Daily steps Standard Deviation 4463.47290

SECONDARY outcome

Timeframe: 6 months

Population: Participants with available data for self-reported exercise

The Godin Leisure-time Exercise Questionnaire will be administered in the pre and post-test surveys. It is a brief and reliable instrument to assess usual leisure-time physical activity behaviour during a one-week period. For the first question, weekly frequencies of strenuous, moderate, and light activities are multiplied by nine, five, and three, respectively. Part two of the questionnaire calculates the frequency of weekly leisure-time activities pursued. Total weekly leisure activity is calculated by summing the products of the separate components. Scores begin at zero, with higher scores indicating greater physical activity. For example, scores equal to or greater than 20 are indicative of someone who is "active". There is no max score.

Outcome measures

Outcome measures
Measure	Women-Only Cardiac Rehabilitation n=37 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models	Co-ed Cardiac Rehabilitation n=40 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models	Home-Based Cardiac Rehabilitation n=31 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
Self-reported Exercise	31.3243 Scores on a scale Standard Deviation 23.46517	31.4 Scores on a scale Standard Deviation 21.7922	29.5645 Scores on a scale Standard Deviation 14.29612

SECONDARY outcome

Timeframe: 6 months

Population: Participants with available data for diet

The Diet Habit Survey was used to assess diet. It is an inexpensive, reliable, and valid instrument for rapid assessment of eating habits and diet composition. Its 9 questions are related to the consumption of cholesterol, saturated fat, complex carbohydrate (including fiber), and salt. Greater scores indicate better diets, both for the total score and for each area. The total score indicates the level of fat in the diet (with scores equal to or greater than 236 corresponding to a low-fat diet 20% or less). Scores can begin at 56 and have no upper range.

Outcome measures

Outcome measures
Measure	Women-Only Cardiac Rehabilitation n=38 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models	Co-ed Cardiac Rehabilitation n=41 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models	Home-Based Cardiac Rehabilitation n=36 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
Diet	202.2019 Scores on a scale Standard Deviation 24.34676	202.3477 Scores on a scale Standard Deviation 27.54240	213.9834 Scores on a scale Standard Deviation 32.89330

SECONDARY outcome

Timeframe: 6 months

Population: Participants with available data for medication adherence

The 4-item Morisky Medication Adherence Scale was used, which is scored as yes = 0, no = 1, such that a higher score indicates higher medication adherence. Scores range from 0 to 4, with patients scoring 2 or above considered adherent.

Outcome measures

Outcome measures
Measure	Women-Only Cardiac Rehabilitation n=38 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models	Co-ed Cardiac Rehabilitation n=42 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models	Home-Based Cardiac Rehabilitation n=36 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
Medication Adherence	3.6842 Scores on a scale Standard Deviation 0.57447	3.5238 Scores on a scale Standard Deviation 0.80359	3.5833 Scores on a scale Standard Deviation 0.76997

SECONDARY outcome

Timeframe: 6 months

Population: Participants with available data for current smoking status. Reported values in the table represent number of participants who were current smokers.

Current smoking status

Outcome measures

Outcome measures
Measure	Women-Only Cardiac Rehabilitation n=38 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models	Co-ed Cardiac Rehabilitation n=42 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models	Home-Based Cardiac Rehabilitation n=36 Participants Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
Smoking	1 Participants	3 Participants	3 Participants

Adverse Events

Women-Only Cardiac Rehabilitation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Co-ed Cardiac Rehabilitation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Home-Based Cardiac Rehabilitation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sherry L Grace

University Health Network & York University

Phone: 416.736.2100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place