Effects of a Walking Program and Inspiratory Muscle Training in Individuals With Chronic Heart Failure - A Pilot Study
Phase: NA
Conditions: Heart Failure NYHA Class II, Heart Failure NYHA Class III
Sponsor: Texas Woman's University

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Effects of a Walking Program and Inspiratory Muscle Training 
 on Individuals with Chronic Heart Failure 
 
 (ClinicalTrials.gov identifier :NCT01560871) 
 
12/2/2013  
 

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Protocol Title 
 
Effects of a walking program and inspiratory muscle training on individuals with chronic 
heart failure - a pilot study 
 
1) Investigator 
Suh-Jen Lin, PT, PhD 
 
2) Objectives  
The purpose of this pilot study is to examine the effects of inspiratory muscle 
training (IMT) plus home-based walking program in individuals with chronic heart 
failure. The primary outcomes are: respiratory muscle strength as indicated by 
maximal inspiratory pressure (PImax), cardiovascular endurance (indicated by the 
six-minute walk test distance), autonomic function (indicated by the heart rate 
variability) and health-related quality of life. We hypothesize that both groups will 
have improvements in PImax, cardiovascular endurance, heart rate variability, and 
quality of life, and that the extent of improvements will be greater for the 
experimental group (high-intensity IMT) than the sham group (low-intensity IMT). 
We plan to recruit patients who are discharged within 6 months after acute illness, 
since these patients may be medically stable and mobility independent, but their 
overall exercise capacity may not be ready for full function in the community yet. 
 
3) Background  
Prevalence of heart failure is approximately 1% [1]. The leading causes of 
heart failure are coronary artery disease, hypertension and diabetes. Other causes 
include cardiomyopathy, heart valve disease, arrhythmia and congenital heart disease. 
Patients often develop symptoms when all compensatory mechanisms fail to provide 
adequate cardiac output of the heart. General fatigue and dyspnea with exercises often 
reduce their desire for physical activity. Deconditioning and dyspnea eventually 
becomes a vicious cycle. Health care cost for patients with heart failure is 
skyrocketing due to its repetitive, costly, and prolonged hospitalization.[2] With an 
increasing elderly population, it is estimated that the burden of care would continue to 
increase for heart failure. 
 
Promoting self-care for individuals with chronic heart failure has been advocated 
in recent years for reducing hospital readmission and mortality rate.[3, 4]Components of 
self-care strategies include healthy diets, smoking cessation, regular physical activity, and 
self-monitoring of weight gain and ankle edema. Among these, physical activity has been 
shown to reduce body mass index, improve blood pressure control, and reduce all causes 
of mortality in all populations.[5] More than 50% of individuals with chronic HF lead a 
sedentary lifestyle with walking for fewer than 5000 steps a day.[6]Daily walking 
performance has been shown to be an independent predictor in discriminating patients 
with advanced heart failure.[7] Furthermore, a longitudinal study showed that daily step 
counts can predict mortality rate.[8] Therefore, the importance of promoting physical 
activity could not be overemphasized for individuals with chronic heart failure. 
 

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Benefits of exercise training in selected individuals with chronic heart failure are 
well documented, including lower hospital readmission rate, better exercise capacity, and 
better health-related quality of life.[9, 10] After being discharged from an acute care 
hospital, individuals with HF may receive a short term phase II cardiac rehab which 
involves professionally monitored exercise training in out-patient settings. Comparing 
home-based to hospital-based exercise training programs, it was found that physical 
activity was maintained in the long term for both groups.[11] For individuals who can not 
participate in hospital-based exercise program due to issues of transportation, finance, 
scheduling, or other health-related issues, they may follow up at an out-patient heart 
failure clinic for routine check-up on symptoms and medications. However, a 
community-based health promotion program to target their physical activities is not 
currently available. High quality randomized controlled trials studies and cost-
effectiveness evidence is needed for community-based exercise training in selected 
patients with chronic heart failure. 
 
Respiratory muscle dysfunction is common in individuals with chronic heart 
failure, which may contribute to their symptoms of exercise intolerance.[12] For them, a 
systematic review on the effects of inspiratory muscle training showed beneficial effects 
on respiratory muscle strength, functional capacity, and quality of life.[13] Whether 
inspiratory muscle training will have additional benefits as compared to aerobic exercise 
training alone, it is not clear and equivocal due to limited data in the literature.[13] For 
them, incorporating breathing exercise into self-monitored physical activity may be a 
viable approach for community-based health promotion programs.  
 
4) Setting of the Human Research 
This study will be conducted at the Texas Woman’s University (TWU) – Dallas 
campus and Presbyterian Hospital of Dallas. TWU-Dallas will serve as the primary 
site for data collection and data management. Presbyterian Hospital of Dallas will 
serve as a site for subjects’ recruitment, specifically the inpatient heart failure unit 
and the outpatient heart failure clinic. The Institutional Review Board of the TWU-
Dallas campus oversees all research projects conducted on the campus from both 
scientific and ethical perspectives. The THR-IRB will oversee the research in the 
Presbyterian Hospital of Dallas (PHD). This proposed study has been approved by the 
TWU-Dallas IRB.  
 
5) Resources available to conduct the Human Research 
a) Co-investigators/research coordinators (Kandice Miller, Marion Wilson) at the 
Presbyterian Hospital of Dallas will help with subject recruitment from both in-
patient heart failure unit and outpatient heart failure clinic. Marion is a research 
nurse and Kandice Miller is a nurse practitioner in charge of the outpatient heart 
failure clinic. Both of them have clinical experiences in patients with chronic 
heart failure, and they are aware of the inclusion/exclusion criteria of the study.  
Dr. Martin Berk is the Director of Texas Health Resources Dallas - Presbyterian 
Dallas Heart Failure Program. Based on their clinical experiences, recruiting 30 
subjects, who fit the criteria of this study, from the Presbyterian Hospital of 

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Dallas in one year is feasible. 
 
b) The proposed time to conduct the trial is one year. 
 
c) The Physical Therapy program at TWU-Dallas campus has the equipment and the 
research space needed for this study. The campus is located in an 8-floor building 
which was opened in 2011 and housed a few health sciences programs such as 
nursing, occupational therapy, and physical therapy programs. There are several 
new equipment and research labs in the building for interdisciplinary research 
related to qualitative and quantitative studies. There is also a counseling clinic 
with two experienced clinical psychologists who can provide psychological 
consultation if needed. There are a few AED (automated external defibrillator) 
available on certain locations of the campus. In addition, across the street of the 
campus is the St. Paul Hospital, researchers can send the participant there in case 
he/she requires medical care as a consequence of the Human Research.  
 
d) The PI will oversee all research activities of the study. There are four DPT 
graduate students helping with this study involving evaluations, reassessment, 
data collection, and data analysis. They participate in this project as a requirement 
of their “Critical Inquiry” courses under the supervision of the PI at the TWU-
Dallas campus. They have taken courses related to research methodology and 
cardiopulmonary physical therapy, and the NIH Human Subjects Protection 
Training. The PI is an experienced physical therapist whose expertise is in the 
management of patients with cardiac or/and pulmonary conditions. The research 
team members are familiar with ECG interpretation and assessment of exercise 
intolerance. They also had practiced the study protocol a few times to ensure they 
are skilled in conducting all procedures efficiently and safely. Two of them will 
conduct the evaluations and the other two research members will conduct the 
weekly re-assessment. The evaluators will be blinded to the group assignment.  
 
6) Study Design  
a) Recruitment Methods 
i) Potential subjects will be identified via medical charts by two research 
coordinators at the PHD.  
ii) Potential subjects will be approached via one of the two ways: (1) when 
discharging from the inpatient heart failure unit, the inpatient research 
coordinator, Marian Wilson, will talk to potential subjects about the study; or 
(2) when they return to the outpatient heart failure clinic for follow up, the 
outpatient research coordinator, Kandice Miller, will talk to them about the 
study. 
iii) It will be emphasized that their participation in the study is completely 
voluntary, and it will not affect their medical treatments in any ways.  
iv) Participants will be paid a total of $50. 

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v) A total of 30 subjects will be enrolled from the Presbyterian Hospital of 
Dallas, excluding screening failure. 
 
b) Inclusion and Exclusion Criteria  
i) Subjects inclusion criteria:  
(1) adults with chronic heart failure (NYHA Functional Class II-III) who are 
just discharged from an acute care hospital in the past three months,  
(2) with BMI < 35 kg/m2, 
(3) greater than 18 years of age, 
(4) walk independently with or without assistive device.  
(note: According to New York Heart Association’s Functional 
Classification, patients who have reasonable compensatory ventricle 
remodeling and relatively normal cardiac output at rest and with 
inadequate increase in cardiac output upon exertion belong to Class II and 
III, whereas those with inadequate cardiac output at rest will be classified 
as NYHA Class IV.) 
 
ii) The total expected number of subjects needed to complete the study is 50 
excluding those screen failure. Thirty subjects will be recruited from the 
Presbyterian Hospital of Dallas.  
 
c) Study Endpoints 
i) The primary study endpoint will be that 30 participants complete all 
evaluations, reassessment, and 6-week of training program. The secondary 
study endpoint would be all data management is completed. 
ii)  The primary safety endpoint would be that participants complete all study 
protocols without adverse responses. The secondary safety endpoint could be 
all research data get kept and protected 10 years accordingly. 
 
d) Procedures involved in the Human Research 
i) This study will be a double-blind randomized controlled study. Evaluators 
will not be aware of subject’s group assignment. Each subject does not know 
group assignment either  
 
ii) Timeline of the procedures 
(1)  Recruitment: Two research coordinators screen medical charts to identify 
potential subjects 
(2)  initial evaluation 
(a) History taking 
(b) set up ECG electrodes on the holter monitor unit to monitor heart 
rhythm throughout the session, 
(c) maximal inspiratory muscle strength test (PImax)   
(d) Grip strength test 
(e) 2-min comfortable walking speed test 
(f) single limb stance test at eyes open and eyes closed conditions 
(g) rest for 15 minutes (supine – standing - supine, 5 min each)  

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(h) 6-minute walk test on a hallway- first trial: assess subject’s 
physiologic responses closely 
(i) resting for 15-20 minutes in sitting and completing two surveys 
(j) 6-minute walk test – 2nd trial : monitor subject’s physiologic responses 
closely 
(k) give a pedometer, an accelerometer, a breathing device, a heart rate 
monitor 
(3) exercise training program at home 
(a) for participants :  
(i) daily walking routine: record daily step counts, duration of 
breathing exercise, and training target of PImax in the log 
(ii) weekly follow-up for re-assessment of PImax at heart failure clinic 
or at the research participant’s home 
(b) for researchers:  
(i) ask subjects for any concerns/difficulties during walking program 
and breathing exercise at weekly follow up: determine whether to 
continue the study or discontinue 
(4) final evaluations : repeat the same tests as those done during the first visit  
 
iii) Procedures: 
The initial evaluation session will last approximately two hours which will 
include the interview to gather basic demographic and medical data such as 
names, telephone  number, complete address, email address, dates of 
treatments and birth date, medications, height, weight, age, and past medical 
history. After the interview, we will measure the maximal inspiratory pressure 
(PImax) that the subject can generate by a pressure threshold spirometer 
(Micro Direct, Inc. ME 04240), which is directly related to respiratory muscle 
strength. Then, the individual will be connected with a holter monitor to 
monitor their heart rate activity.  
 
 
Since most individuals with heart failure are older than 50 years of age, so we 
include 3 outcomes specific to older people. (1) Grip strength: A dynamometer for grip 
strength will be used for 3 trials. (2) Single limb stance test at both eyes open and eyes 
closed conditions. The time to maintain single limb stance will be recorded for 3 trials 
at both conditions. (3) Comfortable speed: the participant will be asked to walk at their 
comfortable speed back and forth over a 44-foot segment of hallway for two minutes. 
The times for completing the 44-foot distance will be measured. Heart rate variability 
will be recorded during the above 3 outcome measures. After these measures, the 
participant will rest for 15 minutes in the following positions: supine (5 min), standing 
(5 min), then in supine again (5 min). The holter monitor will continue to monitor their 
heart rate activity when resting in these 3 positions. 
 
 
After rest, we will set up telemetry ECG system and administer the six-minute 
walk test. The participant will be instructed to walk for 6 minutes and to cover as 
much distance as they can. The distance walked, symptoms and signs of exercise 
intolerance will be monitored and recorded. After the first trial, the participant will be 

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allowed to rest for about 15 minutes to allow heart rate returns to initial baseline (+/- 
5 beats). During this rest period, we will have the participant fill out the 2 
questionnaires (Minnesota Living with Heart Failure Questionnaire and SF36 
Questionnaire). Then, we will repeat the six-minute walk test to account for learning 
effect. The SF-36 questionnaire asks a question regarding sexual difficulties. Subjects 
can refuse to answer if they find it uncomfortable.  
 
 
All the initial outcome evaluations will be repeated after 6 weeks. There will be two 
research team members doing the evaluations and another two research team members 
conduct the weekly re-assessment.   
 
 
Each participant will be unknowingly assigned to one of the two groups: (1) a 
walking program with a sham (low-intensity) Inspiratory Muscle Training (IMT) 
protocol, and (2) a walking program with a real (high intensity) IMT at 60% of 
maximal inspiratory pressure (PImax). Research team members who conduct 
evaluations will be blinded to the group assigned. Only the primary investigator and 
those research members who conduct the weekly re-assessment of PImax know the 
group assignment.  
 
 
 
Each participant will be given an accelerometer to track their 7-day physical 
activity for the first and the last week of training. The home-based walking program 
will consist of walking at an intensity of “somewhat hard” to “hard” on the Rating of 
Perceived Exertion (RPE) scale. Participants will be educated on the 10-point RPE 
scale to judge their fatigue level. For example, at rest, they would rate their exertion 
level as “nothing at all” which is equivalent to “zero” on the RPE scale. If they were 
very tired and shortness of breath after any exhausted activities such as climbing two to 
three flights of stairs, they probably rate their exertion level as “very, very, very hard.” 
The scale has been shown to be highly related to a person’s heart rate. They will be 
advised to slow down if they feel their exertion level is toward the “very hard” level. 
Participants will begin walking at least 15 minutes twice a day, or as tolerated, for 7 
days a week and eventually progress to 45-50 minutes a day by six weeks. They will 
also be instructed to wear a simple pedometer each day to record step counts. During 
their weekly re-assessment visit, a research team member will calculate the “mean” and 
“standard deviation” of their previous 7-day step counts. They are encouraged to reach 
the mean step counts for the following week; however, if they are tired on a specific 
day, they are encouraged to at least reach the lower target (e.g., the mean minus one 
standard deviation of previous week’s step counts). We found this approach to be 
effective based on a case study.  
 
 
For the IMT, the training threshold will be set at 60% of PImax (maximal 
inspiratory pressure) for the experimental group. The participant will perform the 
breathing exercise one session daily with a nose clip used, so the participant breathes 
completely through the mouth. The 6 Interval Levels: (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 
group will be trained at fixed 15% PImax which is lower than the training threshold 

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(i.e., 30% PImax) reported in the literature. The time commitment for their IMT 
exercise is about 15-20 minutes per day for both groups. Each participant will have 
weekly follow up visit which can be done either at our facility or a research team 
member will do a home visit for about 15 to 20 minutes to reassess their new PImax 
and reset the new IMT intensity for the following week. In addition, the research team 
will record their ambulatory activity of the previous week. 
 
Study will be conducted in the research suite (8th floor) at the T. Boone Pickens 
Institute of Health Sciences – Dallas of TWU. There will be no other personnel in the 
area except the research team members. The weekly sessions for reassessment of 
respiratory muscle strength will be conducted in the research suite on TWU-Dallas 
campus, at the outpatient heart failure clinic of the PHD, or at the patient’s home  
whichever is convenient for the participant. 
 
e) Data management  
i) The PI, research coordinators, and research graduate assistants will be 
responsible for data collection and transmission of data. 
 
ii)  No specimens will be collected. 
 
iii)  Data will be transferred from the hard copies of data collection forms to the 
password protected computer for further data management with Excel 
program and SPSS statistical software.  
 
iv) Only subjects’ initials and other study related findings will be record in the 
data forms. During data management, only codes will be used. For example, 
each participant will be coded as "group number + subject number" (e.g., C-1 
(control group, subject 1); E-1 (experimental group-subject 1)). An excel file 
containing the master list of subjects’ initials and codes will be kept in a 
password protected computer. The data will be stored in a locked cabinet at 
Room 5610, School of Physical Therapy of the TWU- Dallas campus. Only 
the research team members have access to the data. All data will be coded. 
The data will be stored for 10 years after completion of the study and it will be 
destroyed after 8/31/2023. 
 
v) Data Analysis: Two-way (group x time) repeated measure ANOVA (or 
multivariate ANOVA) will be used to compare the primary and secondary 
outcome measures between the 2 groups (sham IMT vs. real IMT) and across 
the 2 time points (pre- vs. post-training). The PI will consult a statistical 
consultant for final data analysis in the future.  
 
vi) Most of previous similar studies had sample sizes ranging from 20 to 50 each 
group.  So, we plan to screen enough subjects and enroll 30 subjects from the 
PHD site in one year, excluding screening failure. Other site of the study is the 
TWU-Dallas campus. Eligible patients can refer themselves to our campus via 
words by mouth and flyers. 

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vii) Justification of sample size:  
Based on the systematic review on the effects of inspiratory muscle training 
(IMT) in patients with chronic heart failure by the PI (Lin S. et al 2012), it 
showed that patients with CHF demonstrated significant improvements in 
several outcome measures when compared to control groups after IMT 
training. The improvements include: (1) functional capacity (1.5422 
standardized mean difference (SMD), 95% C.I. with a range of 0.8416 to 
3.6553, p<0.0001); (2) PImax (1.3605 SMD, 95% C.I. with a range of 1.0510 
to 1.6700, p<0.0001); (3) V02 Peak (1.7835 SMD , 95% C.I. with a range of 
1.3625 to 2.2046, p<0.0001);(4) Dyspnea (-0.5973 SMD, 95% C.I. with a 
range of -1.0000 to -0.1946, p<0.0037) . The high standardized mean 
difference (SMD) in all four outcome variables indicates large effect sizes. 
The low p-values in the four outcome variables indicate the large effect sizes 
are unlikely due to chance. Based on the large effect size and the power of 
80%, a sample size of 15 in each group is determined. Considering potential 
drop out, we plan to enroll about 25 participants in each group for the whole 
project.   
 
f) Provisions to monitor the data for the safety of subjects 
N/A - this study only involves minimal risks to subjects. 
 
g) Withdrawal of subjects 
Subjects may withdraw at any time without consequences of any kind or loss of 
benefits to which subjects are otherwise given. If a subject’s medical condition 
got worsen for any reasons and would not benefit from the study, the PI or 
research staff can stop his/her participation. When a subject drops out from the 
study, data management will depend on the extent of data has been collected. The 
PI will consult statistician on this issue at a later stage of the study. 
 
7) Risks to subjects  
a) Possible risks include fatigue, overexertion, or loss of confidentiality. The fatigue 
or overexertion could occur during their daily walking program or breathing 
exercise which will last only a few minutes. Subjects will be advised to judge 
their tolerance with these exercise, then progress the intensity and duration 
gradually according to their own tolerance. 
b) Risks such as embarrassment from filling out sensitive questionnaires could 
happen. If a subject finds any questions in the survey or questionnaire 
discomforting, he/she does not have to answer that question.  
 
8) Potential benefits to subjects  
Subjects will benefit from free access to the breathing exercise training program and 
individually tailored walking program. They may improve their exercise tolerance 
and breathing strength through the study. A free pedometer, a heart rate monitor, and 
a breathing device will be provided to them for free. Each subject will also receive 
$25 at the initial evaluation and another $25 at the final visit after 6 weeks of home-

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based training. 
 
9)  Provisions to protect the privacy interests of subjects  
The evaluations and weekly follow-up will be conducted in a private room or space 
where only the participant and research team members are present, except when they 
are performing the walking tests on a hallway. No other personnel will be allowed in 
the interview area.   
10) 
Provisions to maintain the confidentiality of data  
a) The data will be coded. For example, each participant will be coded as 
"group number + subject number" (e.g., C-1 refers to control group- 
subject 1); E-1 refers to experimental group-subject 1). An excel file with 
the master list linking subjects’ initials and codes will be stored in a 
password protected computer. Only research team members have access to 
the computer. During most of the data management processes, only the 
codes will be used.  
b) The data will be stored in a locked cabinet in Room 5610 at the School of 
Physical Therapy of the TWU- Dallas campus. Only the research team 
members have access to the data. The data will be stored for 10 years after 
completion of the study and it will be deleted from the computer and hard 
copies will be shredded after 8/31/2023. 
11) 
Medical care and compensation for injury 
N/A - this study only involves minimal risks to research participants 
 
12) 
Cost to subjects  
This walking program and breathing exercise will be free to research participants 
in the study.  
 
13) 
Consent process  
a) Subjects will be asked to sign a study consent form after receiving a complete 
explanation of the study. 
 
b) The consent process will be initiated with the subject wherever they are when the 
subject decides they are interested in the study. This will be in one of two 
locations within the Presbyterian Hospital of Dallas: inpatient unit of heart failure 
patients - location A, or outpatient heart failure clinic - location B, if the subject is 
identified while receiving medical services. Prior to initiation of the study, an IRB 
approved copy of the written informed consent form will be obtained. Study 
procedures, guidelines, restrictions and process will be explained to the subject by 
the research coordinator and/or investigator. The subject will then be allowed time 
to read the informed consent and ask any questions. After all questions have been 
answered, the most current approved informed consent will be signed by the 
research subject and witnessed (if required). This must all be done prior to any 
study related procedure being performed.  A signed copy of the informed consent 
will be maintained in the hospital chart if the subject is an inpatient. A signed 

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copy will be given to the subject. The original informed consent will be 
maintained in the subject's research chart.  Once research participants are 
identified by the research coordinators at THR Dallas, these potential research 
participants can call our research lab to schedule the initial evaluation at our 
facility, School of Physical Therapy, TWU Institute of Health Sciences- Dallas 
They can withdraw from the study any time if they decide not to continue. 
 
c) If during the study an amendment to the protocol should occur and the current 
informed consent no longer covers the change caused by the amendment, then the 
IRB will be notified and approval obtained for an amended informed consent.  
When there is an amendment to the informed consent, each subject will be 
informed of the study changes and a copy of the amended informed consent shall 
be obtained from all research subjects if indicated. All informed consents signed 
by a subject will be kept with study records throughout the duration of the study. 
Once the study is completed these consents will be maintained in storage until 
released for destruction by the sponsor. 
d) For research participants, their primary language is not English, an interpreter will 
be used.   
 
14) 
Process to document consent in writing 
Research participants will sign an informed consent if they are interested in 
participating in this study. 
 
15) 
Vulnerable populations: N/A 
 
16) 
Drugs or Devices: N/A 
 
17) 
Multi-site Human Research 
Results of the study will be shared among research members on the TWU-Dallas 
campus and the Presbyterian Hospital of Dallas. Any modifications of the study 
protocol will be communicated within the research team via face to face contacts, 
phone call, text messages, or emails, whichever is the most accessible at the time 
for immediate subject’s protection. 
 
18) 
Sharing of results with subjects 
If the subject would like to know the result of his/her training program, the 
research team will send the participant a hard copy. It is anticipated that the 
findings of the study will be presented in a state or a national conference in the 
future, and the research team will send a copy of the abstract to the participant if 
he/she is interested. 
 
References  
1. Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, 
Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, 

Effects of a walking program and inspiratory muscle training …. 
Version 1 05/03/11 
 
Page 12 of 13 
Original Content Provided by Huron Consulting Services, LLC 
 
Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth 
LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, 
Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, Virani 
SS, Wong ND, Woo D, Turner MB and American Heart Association Statistics 
Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and 
stroke statistics--2013 update: a report from the American Heart Association. Circulation 
2013; 127: 143-152  
2. McDonagh GK. Heart Failure Epidemiology: European Perspective. Curr.Cardiol.Rev. 
2013;  
3. Stamp KD, Machado MA and Allen NA. Transitional Care Programs Improve 
Outcomes for Heart Failure Patients: An Integrative Review. J.Cardiovasc.Nurs. 2013;  
4. Tung HH, Lin CY, Chen KY, Chang CJ, Lin YP and Chou CH. Self-Management 
Intervention to Improve Self-Care and Quality of Life in Heart Failure Patients. Congest 
Heart Fail. 2012;  
5. Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, 
Olkin I and Sirard JR. Using pedometers to increase physical activity and improve health: 
a systematic review. JAMA 2007; 298: 2296-2304  
6. Dontje ML, van der Wal MH, Stolk RP, Brugemann J, Jaarsma T, Wijtvliet PE, van 
der Schans CP and de Greef MH. Daily Physical Activity in Stable Heart Failure Patients. 
J.Cardiovasc.Nurs. 2013;  
7. Jehn M, Schmidt-Trucksass A, Schuster T, Weis M, Hanssen H, Halle M and Koehler 
F. Daily walking performance as an independent predictor of advanced heart failure: 
Prediction of exercise capacity in chronic heart failure. Am.Heart J. 2009; 157: 292-298  
8. Izawa KP, Watanabe S, Oka K, Hiraki K, Morio Y, Kasahara Y, Brubaker PH, Osada 
N, Omiya K and Shimizu H. Usefulness of Step Counts to Predict Mortality in Japanese 
Patients With Heart Failure. Am.J.Cardiol. 2013;  
9. Coats AJ. Clinical utility of exercise training in chronic systolic heart failure. 
Nat.Rev.Cardiol. 2011; 8: 380-392  
10. Davies EJ, Moxham T, Rees K, Singh S, Coats AJ, Ebrahim S, Lough F and Taylor 
RS. Exercise training for systolic heart failure: Cochrane systematic review and meta-
analysis. Eur.J.Heart Fail. 2010; 12: 706-715  
11. Cowie A, Thow MK, Granat MH and Mitchell SL. A comparison of home and 
hospital-based exercise training in heart failure: immediate and long-term effects upon 
physical activity level. Eur.J.Cardiovasc.Prev.Rehabil. 2011; 18: 158-166  

Effects of a walking program and inspiratory muscle training …. 
Version 1 05/03/11 
 
Page 13 of 13 
Original Content Provided by Huron Consulting Services, LLC 
 
12. Ribeiro JP, Chiappa GR, Neder JA and Frankenstein L. Respiratory muscle function 
and exercise intolerance in heart failure. Curr.Heart Fail.Rep. 2009; 6: 95-101  
13. Lin SJ, McElfresh J, Hall B, Bloom R and Farrell K. Inspiratory muscle training in 
patients with heart failure: a systematic review. Cardiopulm.Phys.Ther.J. 2012; 23: 29-36