Effects of a Walking Program and Inspiratory Muscle Training on Individuals With Chronic Heart Failure
Status: | Recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - 90 |
Updated: | 4/21/2016 |
Start Date: | March 2012 |
End Date: | August 2016 |
Contact: | Suh-Jen Lin, PhD, PT |
Email: | slin@twu.edu |
Phone: | 214-689-7718 |
Effects of a Walking Program and Inspiratory Muscle Training on Individuals With Chronic Heart Failure - A Pilot Study
Patients with chronic heart failure need a "safe and effective" exercise program that will
improve their quality of life. For this study, we will determine if adult chronic heart
failure patents assigned to an experimental exercise group of walking and Inspiratory Muscle
Training (IMT) program will have an additional beneficial effects on respiratory muscle
strength (PImax), cardiovascular endurance, quality of life, walking speed, heart rate
variability, and physical activity level compared to subjects who are assigned to the home
walking and "sham" Inspiratory Muscle Training (IMT) program.
improve their quality of life. For this study, we will determine if adult chronic heart
failure patents assigned to an experimental exercise group of walking and Inspiratory Muscle
Training (IMT) program will have an additional beneficial effects on respiratory muscle
strength (PImax), cardiovascular endurance, quality of life, walking speed, heart rate
variability, and physical activity level compared to subjects who are assigned to the home
walking and "sham" Inspiratory Muscle Training (IMT) program.
Participants will be recruited from the outpatient heart failure transitional care clinic at
the Presbyterian Hospital of Dallas and other local heart failure support groups. Flyers
will be distributed to cardiologists, nurse practitioners, a research nurse, and local heart
failure support groups in the Dallas/Ft Worth area. Cardiologists and nurse practitioners
will be 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 will come to our facility for the first initial evaluation session where a
history interview will be conducted to gather demographic data such as age, gender, height,
weight, race/ethnicity and past medical/surgical history. The following baseline data will
be collected: a) two trials of 6 minute walk test, b) respiratory muscle strength (PImax),
c) comfortable walking speed, d) hand grip strength, and e) single limb stance time. During
these testings, heart rate and heart rhythms will be continuously recorded via a holter
monitor. During the rest breaks, research participants will fill out two quality of life
questionnaires (SF-36, Minnesota Living with Heart Failure Questionnaire). After rest
breaks, participants will then repeat the six-minute walk test.
Each participant will be randomly assigned to one of the two groups: a) the walking program
with a high-intensity Inspiratory Muscle Training (IMT) program, OR a walking program with a
sham IMT program. The Sham group will be trained at a low intensity. The training threshold
for the Experimental IMT group will be set at 60% of PImax which will be adjusted during
weekly follow up. The frequency of training: 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 sham IMT intensity will be set at fixed 15% PImax.
Research participants will be blinded to the group assigned. The time commitment for their
IMT training is about 15-20 minutes per training session at home. Weekly follow up on their
maximal inspiratory pressure (PIMax) will be done at the School of Physical Therapy in
Dallas, then they will train at the new IMT training intensity with a breathing device for
15-20 minutes. Researchers will also make a copy of their weekly step counts log. Each
participant will be given a breathing device for the breathing exercise.
Each participant will be also given a pedometer, an accelerometer, and a heart rate monitor
to track their daily step counts and heart rate. The walking program will consist of walking
every day at an intensity of "hard" to "somewhat hard" on the Rating of Perceived Exertion
(RPE) scale. Participants will be instructed to walk 15 minutes twice a day initially, then
progress to 45-50 minutes a day by the end of six weeks.
At the end of 6 weeks, participants will return to our facility for the 2-hour final
evaluation.
the Presbyterian Hospital of Dallas and other local heart failure support groups. Flyers
will be distributed to cardiologists, nurse practitioners, a research nurse, and local heart
failure support groups in the Dallas/Ft Worth area. Cardiologists and nurse practitioners
will be 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 will come to our facility for the first initial evaluation session where a
history interview will be conducted to gather demographic data such as age, gender, height,
weight, race/ethnicity and past medical/surgical history. The following baseline data will
be collected: a) two trials of 6 minute walk test, b) respiratory muscle strength (PImax),
c) comfortable walking speed, d) hand grip strength, and e) single limb stance time. During
these testings, heart rate and heart rhythms will be continuously recorded via a holter
monitor. During the rest breaks, research participants will fill out two quality of life
questionnaires (SF-36, Minnesota Living with Heart Failure Questionnaire). After rest
breaks, participants will then repeat the six-minute walk test.
Each participant will be randomly assigned to one of the two groups: a) the walking program
with a high-intensity Inspiratory Muscle Training (IMT) program, OR a walking program with a
sham IMT program. The Sham group will be trained at a low intensity. The training threshold
for the Experimental IMT group will be set at 60% of PImax which will be adjusted during
weekly follow up. The frequency of training: 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 sham IMT intensity will be set at fixed 15% PImax.
Research participants will be blinded to the group assigned. The time commitment for their
IMT training is about 15-20 minutes per training session at home. Weekly follow up on their
maximal inspiratory pressure (PIMax) will be done at the School of Physical Therapy in
Dallas, then they will train at the new IMT training intensity with a breathing device for
15-20 minutes. Researchers will also make a copy of their weekly step counts log. Each
participant will be given a breathing device for the breathing exercise.
Each participant will be also given a pedometer, an accelerometer, and a heart rate monitor
to track their daily step counts and heart rate. The walking program will consist of walking
every day at an intensity of "hard" to "somewhat hard" on the Rating of Perceived Exertion
(RPE) scale. Participants will be instructed to walk 15 minutes twice a day initially, then
progress to 45-50 minutes a day by the end of six weeks.
At the end of 6 weeks, participants will return to our facility for the 2-hour final
evaluation.
Inclusion Criteria:
- adults with chronic heart failure (NYHA Functional Class II-III)
- BMI < 35 kg/m^2
- Age: 18 to 90 years
- walk independently with or without assisted device
- hospital discharge for CHF in the past six months.
Exclusion Criteria:
- ECG with uncontrolled ventricular arrhythmia
- bronchiectasis
We found this trial at
2
sites
Dallas, Texas 75235
Principal Investigator: Suh-Jen Lin, PT, PhD
Phone: 214-689-7718
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Dallas, Texas 75231
Principal Investigator: Lindsay Letteri, NP
Phone: 214-345-7275
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