Can Rehabilitation After TAVI Precipitate Recovery and Improve Prognosis

NCT ID: NCT02855099

Last Updated: 2018-02-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-01
• Study Completion Date: 2017-07-24

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.

Conditions

Aortic Valve Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

CR group

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.

Group Type: ACTIVE_COMPARATOR

Rehabilitation

Intervention Type: OTHER

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

conservative group

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Rehabilitation

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

michal roll

Director. Research & development, Tel-Aviv Sourasky Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

TASMC-16-UC-0015-16-TLV-CTIL

Identifier Type: -

Identifier Source: org_study_id