Efficacy of a Home-Based Exercise Program for Heart Failure

This study has been terminated.
(Lack of enrollment. Difficult to obtain Physician approval.)
Sponsor:
Collaborator:
New York Institute of Technology
Information provided by (Responsible Party):
Kenneth L Miller, PT, DPT, Catholic Home Care
ClinicalTrials.gov Identifier:
NCT01407185
First received: July 27, 2011
Last updated: December 31, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to determine the efficacy of a multi-disciplinary home program consisting of specific education and home-based individualized combined aerobic and resistance training exercise program for persons with heart failure (NYHA class II-III). The investigators will assess effects on endurance, gait speed, lower extremity strength, hospital re-admission rate and the quality of life in community-dwelling older adults from 60 - 85 years of age over a 12 month period.

Anticipated Results: The researchers expect confirm their hypothesis that there will be a statistically significant difference between the experimental group receiving the combined aerobic and resistance training program and the control group receiving usual care based on strength, endurance, quality of life, falls, and hospital re-admission data.


Condition Intervention
Heart Failure
Other: Resistive Exercise Training

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Home-Based Exercise Program in the Management of Heart Failure: An Evidenced-Based Multi-Disciplinary Approach

Resource links provided by NLM:


Further study details as provided by Catholic Home Care:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: There is expected to be a change along each time point from Baseline to 4 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
    Minnesota Living with Heart Failure Questionnaire


Secondary Outcome Measures:
  • Re-hospitalization rates [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
    Telephone survey for hospitalization incidence from discharge to 12 months.

  • Falls incidence [ Time Frame: 6 Months, 12 Months ] [ Designated as safety issue: No ]
    Telephone survey of falls incidence from discharge to 12 months.

  • Aerobic Capacity/Endurance [ Time Frame: Baseline, subjects will be followed through duration of intervention for an average of 4 weeks ] [ Designated as safety issue: No ]
    2 Minute Step Test

  • Lower Extremity Strength [ Time Frame: Baseline, subjects will be followed through duration of intervention for an average of 4 weeks ] [ Designated as safety issue: No ]
    30 Second Chair Stand Test

  • Gait Speed [ Time Frame: Baseline, subjects will be followed through duration of intervention for an average of 4 weeks ] [ Designated as safety issue: No ]
    Gait speed is a tool that has predictive value. Gait speed identifies persons at high risk of health-related outcomes including mortality and physical disability in well-functioning older people. Gait speed also predicts falls risk, future hospitalization risk and decline in health and status.


Enrollment: 9
Study Start Date: June 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resistive Training
Subjects will be working at 30-60% of 1 RM. The therapist selects theraband that will produce muscle fatigue ~ 15 reps. Subjects should report that the exercise was somewhat light to somewhat hard 11 to 14 on RPE scale. Increase or decrease resistance until the desired RPE is obtained. Continues until momentary fatigue is evidenced. Fatigue is defined as the inability to move through the full ROM in a slow controlled fashion. Record the exercise performed, amount of resistance, and # of good quality reps performed before fatigue was reached. A single set will be done for each muscle group.
Other: Resistive Exercise Training
Resistive Exercises (between 8 and 12 exercises for both upper and lower body) at 30 to 60% of 1 RM for 2x per week for 12 months.
Other Names:
  • exercise training
  • physical therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

On program at Catholic Home Care (CHC) Have a diagnosis of CHF NYHA II or III Medically stable 60 - 85 years of age at completion of study Able to follow commands Normal vision (with corrective lenses, if necessary) Willing to participate in a program for 1 year Have a reliable caregiver that is willing to assist as necessary -

Exclusion Criteria:Latex allergy, Unstable CHF NYHA IV Pain that interferes with activity Active neurological and or orthopedic problems, Cancer, End stage renal disease Decreased balance as indicated on Tinetti balance assessment < 10/16.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01407185

Locations
United States, New York
Catholic Home Care
Holtsville, New York, United States, 11742
Sponsors and Collaborators
Catholic Home Care
New York Institute of Technology
Investigators
Principal Investigator: Kenneth L Miller, PT, DPT Catholic Home Care
Principal Investigator: Veronica Southard, DHSc New York Institute of Technology and Catholic Home Care
  More Information

No publications provided

Responsible Party: Kenneth L Miller, PT, DPT, Co-Principal Investigator, Catholic Home Care
ClinicalTrials.gov Identifier: NCT01407185     History of Changes
Other Study ID Numbers: 2011_HF_STUDY
Study First Received: July 27, 2011
Last Updated: December 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Catholic Home Care:
heart failure
quality of life
fall prevention
endurance
resistive training

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014