Trial Outcomes & Findings for Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack (NCT NCT00929994)

NCT ID: NCT00929994

Last Updated: 2019-04-23

Results Overview

6 minute walk test: the longest distance a person can walk for a duration of 6 minutes

• Recruitment status: COMPLETED
• Target enrollment: 20 participants
• Primary outcome timeframe: Baseline, 3 months, 6 months (Six Minute Walk Distance)
• Results posted on: 2019-04-23

Participant Flow

Participant milestones

Measure	Exercise Participants will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. There will be a 3 month non-intervention period preceding the exercise program. Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.
Overall Study STARTED	20
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Exercise Participants will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. There will be a 3 month non-intervention period preceding the exercise program. Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.
Overall Study Withdrawal by Subject	1
Overall Study medical issue unrelated to intervention	4
Overall Study employment	1

Baseline Characteristics

Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack

Baseline characteristics by cohort

Measure	Exercise n=20 Participants Participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.
Age, Continuous	65 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment Canada	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months, 6 months (Six Minute Walk Distance)

Population: Transient Ischemic Attack participants who completed the 6 month intervention.

6 minute walk test: the longest distance a person can walk for a duration of 6 minutes

Outcome measures

Measure	Exercise n=14 Participants Participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. A 3 month non-intervention period will precede the 6 month cardiac rehabilitation training program. Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.
Functional Walk Test Baseline	498.4 meters Standard Deviation 95.2
Functional Walk Test 3 months	503.2 meters Standard Deviation 111.1
Functional Walk Test 6 months	564.2 meters Standard Deviation 139.6

PRIMARY outcome

Timeframe: Baseline (after the 3 month non-intervention period) and after 6 months of participation.

To measure cardiovascular fitness, a stress test on either an upright cycle ergometer (Ergoselect 200P, Germany), or a treadmill (same modality pre- and post-training) was performed depending on patient balance and comfort.

Outcome measures

Measure	Exercise n=14 Participants Participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. A 3 month non-intervention period will precede the 6 month cardiac rehabilitation training program. Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.
Cardiovascular Fitness (VO2peak) Baseline	16.7 ml/kg/min Standard Deviation 5
Cardiovascular Fitness (VO2peak) 6 months	19.1 ml/kg/min Standard Deviation 4.6

SECONDARY outcome

Timeframe: Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation

Population: Transient Ischemic Attack. Two patients did not complete questionnaires.

Depressive symptoms using the validated Center for Epidemiologic Studies Depression Scale (CES-D). This is a score from a 20 item questionnaire with minimum value of 0 and maximum value of 60 with higher numbers indicated greater depressive symptoms (worse).

Outcome measures

Measure	Exercise n=12 Participants Participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. A 3 month non-intervention period will precede the 6 month cardiac rehabilitation training program. Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.
Center for Epidemiologic Studies Depression Scale (CES-D). 3 months	7.6 score on a scale Standard Deviation 5
Center for Epidemiologic Studies Depression Scale (CES-D). 6 months	4.3 score on a scale Standard Deviation 5.2
Center for Epidemiologic Studies Depression Scale (CES-D). Baseline	6.5 score on a scale Standard Deviation 6

SECONDARY outcome

Timeframe: Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation

Population: TIA. Three subjects did not complete the assessment at each time point.

Montreal Cognitive Assessment. The MoCA score ranges from 0 to 30 points with a higher score indicating better cognitive function.

Outcome measures

Measure	Exercise n=11 Participants Participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. A 3 month non-intervention period will precede the 6 month cardiac rehabilitation training program. Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.
Cognition Baseline	26.5 units on a scale Standard Deviation 2.4
Cognition 3 months	26.8 units on a scale Standard Deviation 3.4
Cognition 6 months	27.1 units on a scale Standard Deviation 2

Adverse Events

Exercise

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.

Toronto Rehab

Phone: 4169781739

Email: dina.brooks@utoronto.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place