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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Withdrawn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
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Aortic Valve Stenosis

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 24, 2016
    Last Updated
    February 14, 2018
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    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    Withdrawn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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