Effects of a Walking Program and Inspiratory Muscle Training on Individuals With Chronic Heart Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Texas Woman's University
Sponsor:
Collaborator:
Presbyterian Hospital of Dallas, Texas Health Resources
Information provided by (Responsible Party):
Suh-Jen Lin, Texas Woman's University
ClinicalTrials.gov Identifier:
NCT01560871
First received: March 20, 2012
Last updated: August 3, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Heart Failure NYHA Class III
Heart Failure NYHA Class II
Behavioral: High-intensity IMT plus walking
Behavioral: Low-intensity IMT plus walking

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Walking Program and Inspiratory Muscle Training on Individuals With Chronic Heart Failure - A Pilot Study

Resource links provided by NLM:


Further study details as provided by Texas Woman's University:

Primary Outcome Measures:
  • Minnesota Living with Heart Failure Questionnaire [ Time Frame: 6-week training ] [ Designated as safety issue: No ]
    This questionnaire includes 21 questions which ask how much the heart condition affected the patient's life during the past month (4 weeks).

  • SF-36 Quality of Life Questionnaire [ Time Frame: 6-week training ] [ Designated as safety issue: No ]
    The SF-36 quality of life questionnaire (short form) will be used.


Secondary Outcome Measures:
  • Heart rate variability [ Time Frame: 6-week training ] [ Designated as safety issue: No ]
    Heart rate and heart rhythm will be recorded via a holter monitor during some testings: comfortable walking speed test, grip strength test, single limb stance test, and resting in supine (5 min) and in standing (5 min) conditions. Data will be analyzed later.

  • Physical Activity [ Time Frame: 6-week training ] [ Designated as safety issue: No ]
    Each subject will be given a pedometer to record his/her step counts every day. They will also wear a heart rate monitor while they walk and record their steps and average heart rate in the walking log. In addition, each subject will wear an accelerometer for the first week and the last week during the study period for validation purpose.

  • respiratory muscle strength [ Time Frame: 6-week training ] [ Designated as safety issue: No ]
    The inspiratory muscle strength will be measured in the unit of cmH2O by the Respiratory Muscle meter (Micro Direct).

  • Six-minute walk test distance [ Time Frame: 6-week training ] [ Designated as safety issue: No ]
    The six-minute walk test is a measure of cardiovascular endurance which measures how far a person can walk in 6 minutes. This test will be conducted twice respectively at pre-training and also post-training to account for potential learning effect.


Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Low-intensity IMT Plus Walking
Inspiratory Muscle Training (IMT) intensity will be set at 15% PImax. 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 at 15 minutes twice a day initially, then progress to 45-50 minutes a day by the end of the six weeks.
Behavioral: Low-intensity IMT plus walking

The IMT training is about 15-20 minutes. Both groups will need to come in once a week for 15 to 20 minutes to probably readjust the IMT training intensity on the breathing device.

For the walking program, each participant will be given a pedometer and a heart rate monitor so he/she can track daily step counts and walking heart rate during the study. 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 begin walking at least 15 minutes twice a day for 7 days a week and eventually progress to 45-50 minutes a day by the end of the six weeks.

Experimental: High-intensity IMT Plus Walking
Inspiratory Muscle Training (IMT) intensity will be set at 60% PImax. 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.
Behavioral: High-intensity IMT plus walking

The IMT intensity will be set at 60% of PImax which will be adjusted weekly and nose clip will be used. Frequency: 5x/week; 1x/day preferred. 6 Interval Levels: (6 efforts at 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.

For the walking program, each participant will be given a pedometer and a heart rate monitor so he/she can track daily step counts and heart rate during the study. 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 begin walking at least 15 minutes twice a day for 7 days a week and eventually progress to 45-50 minutes a day by the end of the six weeks.


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 assisted device
  • hospital discharge for CHF in the past six months.

Exclusion Criteria:

  • ECG with uncontrolled ventricular arrhythmia
  • bronchiectasis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560871

Contacts
Contact: Suh-Jen Lin, PhD, PT 214-689-7718 slin@twu.edu

Locations
United States, Texas
School of Physical Therapy, Texas Woman's University Recruiting
Dallas, Texas, United States, 75235
Contact: Suh-Jen Lin, PT, PhD    214-689-7718    slin@twu.edu   
Principal Investigator: Suh-Jen Lin, PT, PhD         
Outpatient heart failure transitional care clinic, Presbyterian Hospital of Dallas, Texas Health Resources Recruiting
Dallas, Texas, United States, 75231
Contact: Kandice Miller, MS, NP    214-345-2680    KandiceMiller@texashealth.org   
Contact: Martin Berk, MD    2149873572    MBerk@civadallas.com   
Principal Investigator: Kandice Miller, NP         
Sub-Investigator: Martin Berk, MD         
Sponsors and Collaborators
Texas Woman's University
Presbyterian Hospital of Dallas, Texas Health Resources
Investigators
Principal Investigator: Suh-Jen Lin, PhD, PT Texas Woman's University
  More Information

No publications provided

Responsible Party: Suh-Jen Lin, Associate Professor, Texas Woman's University
ClinicalTrials.gov Identifier: NCT01560871     History of Changes
Other Study ID Numbers: 16969
Study First Received: March 20, 2012
Last Updated: August 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Woman's University:
Heart failure
inspiratory muscle training
physical activity

Additional relevant MeSH terms:
Heart Failure
Respiratory Aspiration
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014