Efficacy of a Home-Based Exercise Program for Heart Failure

NCT01407185 | Terminated DMC

• 1 other identifier: 2011_HF_STUDY
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

heart failure; quality of life; fall prevention; endurance; resistive training

Outcome Measures

Primary Outcomes (1)

• Quality of Life

  Minnesota Living with Heart Failure Questionnaire

  There is expected to be a change along each time point from Baseline to 4 weeks, 6 months, 12 months

Secondary Outcomes (5)

• Re-hospitalization rates

  6 months, 12 months

• Falls incidence

  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

• Gait Speed

  Baseline, subjects will be followed through duration of intervention for an average of 4 weeks

Study Arms (1)

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.

Other: Resistive Exercise Training

Interventions

Resistive Exercise Training OTHER

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.

Also known as: exercise training, physical therapy

Resistive Training

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

Sponsors & Collaborators

• Catholic Home Care: lead
• New York Institute of Technology: collaborator

Study Sites (1)

Catholic Home Care

Holtsville, New York, 11742, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Exercise; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Rehabilitation

Study Officials

• Kenneth L Miller, PT, DPT

  Catholic Home Care

  PRINCIPAL INVESTIGATOR

• Veronica Southard, DHSc

  New York Institute of Technology and Catholic Home Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: July 27, 2011
• First Posted: August 2, 2011
• Study Start: June 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: January 3, 2013

Record last verified: 2012-12

Locations

US (1)