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Clinical Trials/NCT01407185
NCT01407185TerminatedNot Applicable

Efficacy of a Home-Based Exercise Program in the Management of Heart Failure: An Evidenced-Based Multi-Disciplinary Approach

Catholic Home Care2 sites in 1 country9 target enrollmentStarted: June 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
9
Locations
2
Primary Endpoint
Quality of Life

Study Overview

Brief Summary

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.

Detailed Description

This study is IRB approved at Catholic Home Care and at New York Institute of Technology due to collaboration between Catholic Home Care and New York Institute of Technology. Subjects will be volunteers, recruited during the initial therapy visit from 10 trained CHC staff and subsequently randomized based on their patient identification number into an experimental group or experimental group after consent has been obtained.

Subjects will sign a consent form to enter the study. Two groups of 40 subjects will be required to finish in order to obtain power of 80 at an alpha of .05. The subjects will be living at home with a reliable caregiver. The nurse will provide current best practice to all CHF patients in the study which includes educating the patient and caregiver regarding diet, medication regime, monitoring for signs and symptoms to report and provide coordination of other disciplines such as social work for those with depression requiring additional management during OASIS screening.

During the initial physical therapy visit, the usual care assessment will be performed, in addition, to obtaining pre-test baseline data for the experimental and control groups. A preliminary home exercise program will be assigned. A handout on pacing activity and deep breathing will be given. The importance of and reason for the perceived exertion scale will be explained to experimental group subjects and a handout will be given that will be part of the study packet.

All subjects will be encouraged to complete the home aerobic portion a minimum of 2 times per day and will be given an activity log from which to check off the same and enter the number and distance achieved when walking for exercise. Resistance exercises will be done at least twice per week with one day of rest between sessions. For the control group subsequent sessions will include usual home care physical therapy consisting of breathing exercises, therapeutic exercise, transfer, gait training, and home exercise programs. Baseline measurements (field testing) will be completed at the initial evaluation and discharge from therapy. In addition, the Minnesota Living with Heart Failure Questionnaire (MLHFQ), and questions about re-hospitalizations, activity logs, falls follow up will be collected and reviewed at 6 and 12 months after the program.

Baseline measurements: The 2-Minute step test (2MST) is an aerobic measure that has been used with older adults.17 The subject is instructed to raise the knee joint to a point halfway between the patella and iliac crest at a comfortable pace for 2 minutes. It is scored by counting the number of times the right knee reaches the point described for 2 minutes. Vital signs including BP, PR, RR, RPE, pulse ox, and signs and symptoms of decompensation are monitored before, during and after test administration. The 2MST has been validated to several other measurement tools of aerobic capacity/endurance.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
60 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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/

Arms & Interventions

Resistive Training

Experimental

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.

Intervention: Resistive Exercise Training (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Falls incidence(6 Months, 12 Months)
  • Gait Speed(Baseline, subjects will be followed through duration of intervention for an average of 4 weeks)
  • Re-hospitalization rates(6 months, 12 months)
  • Aerobic Capacity/Endurance(Baseline, subjects will be followed through duration of intervention for an average of 4 weeks)
  • Lower Extremity Strength(Baseline, subjects will be followed through duration of intervention for an average of 4 weeks)

Investigators

Sponsor
Catholic Home Care
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kenneth L Miller, PT, DPT

Co-Principal Investigator

Catholic Home Care

Study Sites (2)

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