Can Rehabilitation After TAVI Precipitate Recovery and Improve Prognosis
Primary Purpose
Aortic Valve Stenosis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rehabilitation
Sponsored by
About this trial
This is an interventional supportive care trial for Aortic Valve Stenosis
Eligibility Criteria
Inclusion Criteria:
- All TAVI patients above the age of 75
- male or female
- undergoing the TAVI procedure between 1 March 2016 - 1 March 2017
- signed informed consent.
Exclusion Criteria:
- Unstable clinical condition - according to treating physician.
- Handicap before the procedure.
- Severe cognitive decline.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
CR group
conservative group
Arm Description
patients will be referred to our rehabilitation centre at the following week after the procedure, and assigned to a personalized rehabilitation program for duration of 3 month.
No intervention
Outcomes
Primary Outcome Measures
quality of life questionnaire
6 min walk test
number of meters the patient walked for 6 minutes to test the physical performance by the patient.
Secondary Outcome Measures
Full Information
NCT ID
NCT02855099
First Posted
July 24, 2016
Last Updated
February 14, 2018
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02855099
Brief Title
Can Rehabilitation After TAVI Precipitate Recovery and Improve Prognosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Why Stopped
could not find eligible patients
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
July 23, 2017 (Actual)
Study Completion Date
July 24, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Many patients we encounter a month post TAVI, still complain of having symptoms limiting their daily activity. The investigators set out to study whether rehabilitation strategy early after the procedure contributes to reduction of the physical disability these patients suffer from.
Cardiac rehabilitation (CR) is a well-established treatment in patients who underwent cardiac surgery. Patients after TAVI, are natural candidates for referral to exercise-based CR. Despite this, until 2013 no data have been available about the safety and the efficacy of a comprehensive rehabilitative period in these subjects. CR is a helpful tool to maintain independency for daily life activities and participation in socio-cultural life. despite these differences, both patient groups did benefit in the same way from a post-acute in-patient rehabilitation program as assessed by 6-Minute Walking Tests and FIM scores. Patients who were unable to walk and those were slow walkers at baseline experienced an improvement in functional status after TAVI, whereas the fast walkers did not improve and actually experienced a modest decrease in 6MWTD.It has been shown that patients referred for rehabilitation after TAVI are often very frail, with a high grade of functional impairment, dependence on others and high risk of clinical complications. During a rehabilitation program, based on a multidimensional assessment and intervention, most patients showed significant improvement in functional status, quality of life, and autonomy, which remained stable in the majority of subjects during mid-term follow-up.
To the investigators knowledge, no prospective study compared rehabilitation strategy to conservative treatment after TAVI. the investigators set off to test the investigators hypothesize that CR may help in the short and long term prognosis of these patients.
Detailed Description
Many patients we encounter a month post TAVI, still complain of having symptoms limiting their daily activity. The investigators set out to study whether rehabilitation strategy early after the procedure contributes to reduction of the physical disability these patients suffer from.
Cardiac rehabilitation (CR) is a well-established treatment in patients who underwent cardiac surgery. Patients after TAVI, are natural candidates for referral to exercise-based CR. Despite this, until 2013 no data have been available about the safety and the efficacy of a comprehensive rehabilitative period in these subjects. Nicola Russo et al. compared the safety and efficacy of a structured, exercise-based CR program in octogenarians after a traditional sAVR vs. TAVI, and concluded that a short-term, supervised, exercise-based CR is feasible, safe and effective in octogenarian patients after TAVI as well as after traditional surgery. An early CR program enhances independence, mobility and functional capacity and should be encouraged in all patients. Long-term effects and prognostic relevance should be evaluated in future studies. A similar comparison assessed the hypothesis that patients after TAVI benefit from CR, compared to patients after surgical aortic-valve replacement (sAVR). They too concluded that patients after TAVI benefit from cardiac rehabilitation despite their older age and comorbidities. CR is a helpful tool to maintain independency for daily life activities and participation in socio-cultural life. The same conclusion was made by Ivan Fauchère et al. letter to the editor - patients in the TAVI group were older and sicker than SAVR patients. Despite these differences, both patient groups did benefit in the same way from a post-acute in-patient rehabilitation program as assessed by 6-Minute Walking Tests and FIM scores.
Another study, drawn from a cohort of 484 patients with severe symptomatic AS who underwent TAVI, evaluated the association between physical performance as estimated by the 6-minute walk test distance (6MWTD) and long-term prognosis after TAVI. They found that compared with those with 6MWTD above the median value, those who were unable to walk experienced a higher rate of death after TAVI. In contrast, patients who were unable to walk and those were slow walkers at baseline experienced an improvement in functional status after TAVI, whereas the fast walkers did not improve and actually experienced a modest decrease in 6MWTD.
It has been shown that patients referred for rehabilitation after TAVI are often very frail, with a high grade of functional impairment, dependence on others and high risk of clinical complications. During a rehabilitation program, based on a multidimensional assessment and intervention, most patients showed significant improvement in functional status, quality of life, and autonomy, which remained stable in the majority of subjects during mid-term follow-up.
To the investigators knowledge, no prospective study compared rehabilitation strategy to conservative treatment after TAVI. the investigators set off to test our hypothesize that CR may help in the short and long term prognosis of these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CR group
Arm Type
Active Comparator
Arm Description
patients will be referred to our rehabilitation centre at the following week after the procedure, and assigned to a personalized rehabilitation program for duration of 3 month.
Arm Title
conservative group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
The duration on the rehabilitation will be 3 month and will be a multidisciplinary program that includes supervised physical activity
Primary Outcome Measure Information:
Title
quality of life questionnaire
Time Frame
3 months
Title
6 min walk test
Description
number of meters the patient walked for 6 minutes to test the physical performance by the patient.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All TAVI patients above the age of 75
male or female
undergoing the TAVI procedure between 1 March 2016 - 1 March 2017
signed informed consent.
Exclusion Criteria:
Unstable clinical condition - according to treating physician.
Handicap before the procedure.
Severe cognitive decline.
12. IPD Sharing Statement
Plan to Share IPD
No
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Can Rehabilitation After TAVI Precipitate Recovery and Improve Prognosis
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