Heart Failure NYHA Class III Clinical Trial
Official title:
Effects of a Walking Program and Inspiratory Muscle Training in Individuals With Chronic Heart Failure - A Pilot Study
Individuals with chronic heart failure need a "safe and effective" exercise program that could enhance their quality of life. In this study, we examined whether an experimental exercise program of autonomous walking and high-intensity Inspiratory Muscle Training (IMT) could result in better effects on respiratory muscle strength (PImax), cardiovascular endurance, quality of life, and physical activity, when compared to autonomous walking and "sham" IMT program, in adults with chronic heart failure.
Participants were recruited from the outpatient heart failure transitional care clinic at the
Presbyterian Hospital of Dallas and other local heart failure support groups. Flyers were
distributed to cardiologists, nurse practitioners, and local heart failure support groups in
the Dallas/Ft Worth area. Cardiologists and nurse practitioners were aware of the scope of
the study and its inclusion and exclusion criteria of research participants. Potential
research participants could then call the research team for further information.
Participants came to our facility for the initial evaluation session, where a history
interview was conducted to gather demographic data, such as age, gender, height, weight,
race/ethnicity, and past medical/surgical history. The following baseline data were then
collected: a) two trials of the six-minute walk test, b) respiratory muscle strength
indicated by maximal inspiratory pressure (PImax), and two quality of life questionnaires.
During the walk test, heart rate and heart rhythms were continuously monitored via a holter
monitor. During the rest breaks, research participants filled out two quality of life
questionnaires (SF-36, Minnesota Living with Heart Failure Questionnaire).
Each participant was randomly assigned to one of the two groups: a) the autonomous walking
program with a high-intensity Inspiratory Muscle Training (IMT) program, or b) the autonomous
walking program with a sham IMT. The training threshold for the experimental IMT group was
trained at 60%PImax which was reassessed at weekly follow ups. The frequency of training was
5x/week (1x/day preferred) for 6 interval levels at each session (6 inspiratory efforts in
each level): (1) 60s rest interval; (2) 45s rest interval; (3) 30s rest interval; (4) 15s
rest interval; (5)10s rest interval; (6) 5s rest interval, trained to exhaustion. The
intensity of sham IMT was set at fixed 15% PImax. Research participants were blinded to the
group assignment. The time commitment for IMT was about 15-20 minutes a session per day at
home. Weekly follow up was conducted at the School of Physical Therapy in Dallas to reassess
PImax, collect the log of daily step count, and discuss about the walking program. Every
participant was given a breathing device for inspiratory muscle training.
Each participant was given a pedometer and a heart rate monitor to track their daily step
counts and heart rate during the walking session. The walking program consisted of walking
daily at an intensity of "somewhat hard" to "hard" on the Borg's Rating of Perceived Exertion
(RPE) scale. Participants were encouraged to walk 10 to 15 minutes, once to twice a day
initially, then progressed to about 45-50 minutes a day by week six, if they could tolerate.
At the end of 6 weeks, these participants returned to our facility for the final evaluation
session.
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