Cardiac Rehab for Advanced Heart Failure-LVAD Candidates

NCT03132441 | Withdrawn

• 1 other identifier: 17-000210
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a pilot study evaluating the feasibility and early efficacy of cardiac rehabilitation to improve frailty and symptoms in patients with advanced heart failure (NYHA class III-IV), who are being considered for LVAD therapy.

Conditions

Heart Failure

Keywords

advanced heart failure; NYHA Class III-IV; frailty; cardiac rehabilitation

Outcome Measures

Primary Outcomes (2)

• Change in frailty marker handgrip strength

  Frailty is assessed by the strength of a participant's handgrip, measured using a commercial device.

  Baseline, 6 weeks

• Change in frailty marker gait speed

  Frailty is assessed by the strength of a participant's gait speed, measured using a commercial device.

  Baseline, 6 weeks

Secondary Outcomes (3)

• Change in New York Heart Association (NYHA) classification

  Baseline, 6 weeks

• Change in Minnesota Living with Heart Failure (MLHF) score

  Baseline, 6 weeks

• Change in KCCQ score

  Baseline, 6 weeks

Study Arms (1)

Cardiac Rehabilitation

EXPERIMENTAL

Strength Training for Frailty: All patients enrolled will be enrolled in 6 weeks of cardiac rehabilitation for the pilot study.

Other: Strength Training for Frailty

Interventions

Strength Training for Frailty OTHER

Cardiac Rehabilitation, abbreviated course

Cardiac Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Candidate for a Left Ventricular Assist Device (LVAD)
• Advanced Heart Failure as determined by New York Heart Association classification III or IV

You may not qualify if:

• Unable to perform physical activities required by protocol due to anatomic or musculoskeletal comorbidities
• Physical activity is contraindicated

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic-Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (6)

• Singh M, Stewart R, White H. Importance of frailty in patients with cardiovascular disease. Eur Heart J. 2014 Jul;35(26):1726-31. doi: 10.1093/eurheartj/ehu197. Epub 2014 May 26.

  PMID: 24864078 BACKGROUND

• Dunlay SM, Park SJ, Joyce LD, Daly RC, Stulak JM, McNallan SM, Roger VL, Kushwaha SS. Frailty and outcomes after implantation of left ventricular assist device as destination therapy. J Heart Lung Transplant. 2014 Apr;33(4):359-65. doi: 10.1016/j.healun.2013.12.014. Epub 2013 Dec 27.

  PMID: 24486165 BACKGROUND

• Thalji NM, Suri RM, Greason KL, Schaff HV. Risk assessment methods for cardiac surgery and intervention. Nat Rev Cardiol. 2014 Dec;11(12):704-14. doi: 10.1038/nrcardio.2014.136. Epub 2014 Sep 23.

  PMID: 25245832 BACKGROUND

• Flint KM, Matlock DD, Lindenfeld J, Allen LA. Frailty and the selection of patients for destination therapy left ventricular assist device. Circ Heart Fail. 2012 Mar 1;5(2):286-93. doi: 10.1161/CIRCHEARTFAILURE.111.963215. No abstract available.

  PMID: 22438521 BACKGROUND

• Chung CJ, Wu C, Jones M, Kato TS, Dam TT, Givens RC, Templeton DL, Maurer MS, Naka Y, Takayama H, Mancini DM, Schulze PC. Reduced handgrip strength as a marker of frailty predicts clinical outcomes in patients with heart failure undergoing ventricular assist device placement. J Card Fail. 2014 May;20(5):310-5. doi: 10.1016/j.cardfail.2014.02.008. Epub 2014 Feb 22.

  PMID: 24569037 BACKGROUND

• Molino-Lova R, Pasquini G, Vannetti F, Paperini A, Forconi T, Polcaro P, Zipoli R, Cecchi F, Macchi C. Effects of a structured physical activity intervention on measures of physical performance in frail elderly patients after cardiac rehabilitation: a pilot study with 1-year follow-up. Intern Emerg Med. 2013 Oct;8(7):581-9. doi: 10.1007/s11739-011-0654-z. Epub 2011 Jul 9.

  PMID: 21744061 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Frailty

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sudhir S Kushwaha, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Single arm pilot study

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: April 27, 2017
• Study Start: April 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)