Clinical trial NCT01560871: Effects of a Walking Program and Inspiratory Muscle Training in Individuals With Chronic Heart Failure
Official title: Effects of a Walking Program and Inspiratory Muscle Training in Individuals With Chronic Heart Failure - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure NYHA Class II
Heart Failure NYHA Class III
Keywords: Heart failure
inspiratory muscle training
physical activity
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
Collaborators: name: Texas Health Resources
First posted: 2012-03-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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 an assisted device
* hospital discharge for CHF within a year.

Exclusion Criteria:

* ECG with uncontrolled ventricular arrhythmia
* bronchiectasis
* limited walking ability due to neurologic or orthopedic impairments of the legs

Primary outcomes:
measure: Change From Baseline in Mean Minnesota Living With Heart Failure Questionnaire Score
timeFrame: Baseline and 6 weeks
measure: Change From Baseline in Mean Score of Physical Component of the SF-36 Questionnaire
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Mean Daily Step Counts From Week 1 to Week 6
timeFrame: Baseline and 6 weeks
measure: Respiratory Muscle Strength is Indicated by Maximal Inspiratory Pressure (PImax)
timeFrame: Baseline and 6 weeks
measure: Six-minute Walk Test Distance
timeFrame: Baseline and 6 Weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Outpatient heart failure transitional care clinic, Presbyterian Hospital of Dallas, Texas Health Resources
state: Texas
city: Dallas
country: United States
facility: School of Physical Therapy, Texas Woman's University
state: Texas
Study officials:
affiliation: Texas Woman's University
name: Suh-Jen Lin, PhD, PT
role: PRINCIPAL_INVESTIGATOR
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