Back to resultsHeart Failure and Regional Specific Exercise Training Stimulus (HF-RSTS)
Primary Purpose
Heart Failure, Sedentary
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Regional Specific Training (RSTS)
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Functional Capacity, Exercise Independence, Peripheral, Strength
Eligibility Criteria
Inclusion Criteria:
- Men and women between the ages of 55 and 90
- Diagnosed with heart failure (NYHA class II-III)
- Receiving optimal medical therapy
- Sedentary (≤ 30 min/wk structured physical activity)
- Peak VO2 between 10 and 30 mL/kg/min.
Exclusion Criteria:
- Oxygen dependent
- Recent medications changes (within 3 months)
- Fixed-rate pacemakers
- Uncontrolled hypertension
- Type I diabetes
- Organ transplant
- Bariatric surgery
- Renal failure (stage 4 or 5)
Sites / Locations
- Duke Center for Living; Wallace Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Regional Specific Training (RSTS)
Arm Description
The RSTS protocol was designed to focus on specific peripheral muscle groups without imposing a significant cardiorespiratory strain. Each exercise involved contractions with moderate load but with an extended duration of up to six minutes. Eight specific exercises were performed to target all major muscle groups and enable the routine to be completed within 60 minutes including warm-up, rest periods and stretching between exercises, and cool down exercises
Outcomes
Primary Outcome Measures
Subject Adherence & Compliance
The number of training sessions attended and successfully completed divided by the total number of planned sessions
One Repetition Maximum (1RM)
Skeletal muscle strength assessed using a one repetition maximum (1RM) measurement obtained for the seated row, chest press, leg press and handgrip.
Senior Fitness Test
The Senior Fitness Test is a previously validated battery of 6 physical tasks of daily living used to assess strength, flexibility and endurance in order to detect and predict future limitations in functional capacity. The test is designed to evaluate physical fitness domains including upper-body strength (Arm Curl), lower-body strength (Chair Sit-Stand), upper and lower body flexibility (Back Scratch and Chair Sit and Reach), balance and coordination (8 foot Up and Go), and endurance (Six Minute Walk).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02077426
Brief Title
Heart Failure and Regional Specific Exercise Training Stimulus
Acronym
HF-RSTS
Official Title
Heart Failure and Regional Specific Exercise Training Stimulus
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Withdrawn
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to determine whether heart failure patients can tolerate a four-weeks of a new exercise training regimen that targets peripheral tissues (Regional Specific Training Stimulus-RSTS) and has been show to produce significant benefits in aerobic capacity and strength in healthy subjects aged 70+years who were at risk for losing functional independence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Sedentary
Keywords
Functional Capacity, Exercise Independence, Peripheral, Strength
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regional Specific Training (RSTS)
Arm Type
Experimental
Arm Description
The RSTS protocol was designed to focus on specific peripheral muscle groups without imposing a significant cardiorespiratory strain. Each exercise involved contractions with moderate load but with an extended duration of up to six minutes. Eight specific exercises were performed to target all major muscle groups and enable the routine to be completed within 60 minutes including warm-up, rest periods and stretching between exercises, and cool down exercises
Intervention Type
Other
Intervention Name(s)
Regional Specific Training (RSTS)
Intervention Description
The RSTS protocol was designed to focus on specific peripheral muscle groups without imposing a significant cardiorespiratory strain. Each exercise involved contractions with moderate load but with an extended duration of up to six minutes. Eight specific exercises were performed to target all major muscle groups and enable the routine to be completed within 60 minutes including warm-up, rest periods and stretching between exercises, and cool down exercises.
Primary Outcome Measure Information:
Title
Subject Adherence & Compliance
Description
The number of training sessions attended and successfully completed divided by the total number of planned sessions
Time Frame
4 Weeks
Title
One Repetition Maximum (1RM)
Description
Skeletal muscle strength assessed using a one repetition maximum (1RM) measurement obtained for the seated row, chest press, leg press and handgrip.
Time Frame
4 Weeks
Title
Senior Fitness Test
Description
The Senior Fitness Test is a previously validated battery of 6 physical tasks of daily living used to assess strength, flexibility and endurance in order to detect and predict future limitations in functional capacity. The test is designed to evaluate physical fitness domains including upper-body strength (Arm Curl), lower-body strength (Chair Sit-Stand), upper and lower body flexibility (Back Scratch and Chair Sit and Reach), balance and coordination (8 foot Up and Go), and endurance (Six Minute Walk).
Time Frame
4 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women between the ages of 55 and 90
Diagnosed with heart failure (NYHA class II-III)
Receiving optimal medical therapy
Sedentary (≤ 30 min/wk structured physical activity)
Peak VO2 between 10 and 30 mL/kg/min.
Exclusion Criteria:
Oxygen dependent
Recent medications changes (within 3 months)
Fixed-rate pacemakers
Uncontrolled hypertension
Type I diabetes
Organ transplant
Bariatric surgery
Renal failure (stage 4 or 5)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason D Allen, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Center for Living; Wallace Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
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Heart Failure and Regional Specific Exercise Training Stimulus
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