Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00929994
Recruitment Status : Completed
First Posted : June 30, 2009
Results First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Dina Brooks, Toronto Rehabilitation Institute

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Transient Ischemic Attack
Intervention Behavioral: Cardiac Rehabilitation
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Exercise
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 20
Completed 14
Not Completed 6
Reason Not Completed
Withdrawal by Subject             1
medical issue unrelated to intervention             4
employment             1
Arm/Group Title Exercise
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
65  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
13
  65.0%
Male
7
  35.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 20 participants
20
1.Primary Outcome
Title Functional Walk Test
Hide Description 6 minute walk test: the longest distance a person can walk for a duration of 6 minutes
Time Frame Baseline, 3 months, 6 months (Six Minute Walk Distance)
Hide Outcome Measure Data
Hide Analysis Population Description
Transient Ischemic Attack participants who completed the 6 month intervention.
Arm/Group Title Exercise
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: meters
Baseline 498.4  (95.2)
3 months 503.2  (111.1)
6 months 564.2  (139.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise
Comments With 1 group and 3 test times, a repeated measures analysis of variance of 6MWD, was utilized between the 3 test times 0, 3, and 6 months). A Bonferroni correction for multiple testing was used for post hoc contrasts.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.06
Comments A Bonferroni correction for multiple testing was used for post hoc contrasts. Assumption of sphericity was met for all analyses determined by the Mauchley test of sphericity (all >.05).
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Exercise
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Cardiovascular Fitness (VO2peak)
Hide Description 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.
Time Frame Baseline (after the 3 month non-intervention period) and after 6 months of participation.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exercise
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: ml/kg/min
Baseline 16.7  (5)
6 months 19.1  (4.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Center for Epidemiologic Studies Depression Scale (CES-D).
Hide Description 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).
Time Frame Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation
Hide Outcome Measure Data
Hide Analysis Population Description
Transient Ischemic Attack. Two patients did not complete questionnaires.
Arm/Group Title Exercise
Hide Arm/Group Description:

Participants in this group will participate in Cardiac Rehabilitation, carrying out an exercise program after a 12 week period of non intervention 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.

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 6.5  (6)
3 months 7.6  (5)
6 months 4.3  (5.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise
Comments With 1 group and 3 test times, a repeated measures analysis of variance with pairwise comparisons of CES-D was utilized between the 3 test times baseline, 3 and 6 months.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments A Bonferroni correction for multiple testing was used for post-hoc contrasts.
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Cognition
Hide Description Montreal Cognitive Assessment. The MoCA score ranges from 0 to 30 points with a higher score indicating better cognitive function.
Time Frame Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation
Hide Outcome Measure Data
Hide Analysis Population Description
TIA. Three subjects did not complete the assessment at each time point.
Arm/Group Title Exercise
Hide Arm/Group Description:

Following a 3 month non intervention period, 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.

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 26.5  (2.4)
3 months 26.8  (3.4)
6 months 27.1  (2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exercise
Comments With 1 group and 3 test times, a repeated measures analysis of variance with pairwise comparisons of MoCA was utilized between the 3 test times (-3, 0 and 6 months). A Bonferroni correction for multiple testing was used for post-hoc contrasts.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments A Bonferroni correction for multiple testing was used for post-hoc contrasts
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exercise
Hide Arm/Group Description

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 cardiac rehabilitation.

Cardiac Rehabilitation: Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.

All-Cause Mortality
Exercise
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Exercise
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Exercise
Affected / at Risk (%)
Total   0/20 (0.00%) 
This study was conducted in a single centre located in a large city centre and may lack generalizability to other programs, including those where CR services are not publicly funded.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr.
Organization: Toronto Rehab
Phone: 4169781739
Responsible Party: Dina Brooks, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT00929994     History of Changes
Other Study ID Numbers: Brooks - 001
First Submitted: June 29, 2009
First Posted: June 30, 2009
Results First Submitted: April 15, 2017
Results First Posted: April 23, 2019
Last Update Posted: April 23, 2019