Efficacy of a Home-Based Exercise Program for Heart Failure
|ClinicalTrials.gov Identifier: NCT01407185|
Recruitment Status : Terminated (Lack of enrollment. Difficult to obtain Physician approval.)
First Posted : August 2, 2011
Last Update Posted : January 3, 2013
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 or disease||Intervention/treatment||Phase|
|Heart Failure||Other: Resistive Exercise Training||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Efficacy of a Home-Based Exercise Program in the Management of Heart Failure: An Evidenced-Based Multi-Disciplinary Approach|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
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.
- 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 ]Minnesota Living with Heart Failure Questionnaire
- Re-hospitalization rates [ Time Frame: 6 months, 12 months ]Telephone survey for hospitalization incidence from discharge to 12 months.
- Falls incidence [ Time Frame: 6 Months, 12 Months ]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 ]2 Minute Step Test
- Lower Extremity Strength [ Time Frame: Baseline, subjects will be followed through duration of intervention for an average of 4 weeks ]30 Second Chair Stand Test
- Gait Speed [ Time Frame: Baseline, subjects will be followed through duration of intervention for an average of 4 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407185
|United States, New York|
|Catholic Home Care|
|Holtsville, New York, United States, 11742|
|Principal Investigator:||Kenneth L Miller, PT, DPT||Catholic Home Care|
|Principal Investigator:||Veronica Southard, DHSc||New York Institute of Technology and Catholic Home Care|