Can Rehabilitation After TAVI Precipitate Recovery and Improve Prognosis

NCT02855099 | Withdrawn

• 1 other identifier: TASMC-16-UC-0015-16-TLV-CTIL
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (2)

• quality of life questionnaire

  3 months

• 6 min walk test

  number of meters the patient walked for 6 minutes to test the physical performance by the patient.

  3 months

Study Arms (2)

CR group

ACTIVE COMPARATOR

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.

Other: Rehabilitation

conservative group

NO INTERVENTION

No intervention

Interventions

Rehabilitation OTHER

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

CR group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unstable clinical condition - according to treating physician.
• Handicap before the procedure.
• Severe cognitive decline.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director. Research & development, Tel-Aviv Sourasky Medical Center

Study Record Dates

• First Submitted: July 24, 2016
• First Posted: August 4, 2016
• Study Start: August 1, 2016
• Primary Completion: July 23, 2017
• Study Completion: July 24, 2017
• Last Updated: February 15, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share