Can Rehabilitation After TAVI Precipitate Recovery and Improve Prognosis

NCT02855099 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-02-15

No results posted yet for this study

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.

Conditions

  • Aortic Valve Stenosis

Interventions

OTHER

Rehabilitation

The duration on the rehabilitation will be 3 month and will be a multidisciplinary program that includes supervised physical activity

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-01
Primary Completion
2017-07-23
Completion
2017-07-24

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02855099 on ClinicalTrials.gov