Heart Failure and Regional Specific Exercise Training Stimulus

Not Applicable

Withdrawn

• Conditions: Heart Failure; Sedentary
• Interventions: Other: Regional Specific Training (RSTS)

• Registration Number: NCT02077426
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-28
• Status Verified: 2014-03
• Study First Submitted QC: 2014-03-03
• Study First Posted: 2014-03-04
• Study Start: 2014-06
• Last Update Submitted: 2014-09-16
• Last Update Posted: 2014-09-17
• Primary Completion: 2016-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Regional Specific Training (RSTS)	Regional Specific Training (RSTS)	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 Measures

Name	Time	Method
Subject Adherence & Compliance	4 Weeks	The number of training sessions attended and successfully completed divided by the total number of planned sessions
One Repetition Maximum (1RM)	4 Weeks	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	4 Weeks	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).

Trial Locations

Locations (1)

Duke Center for Living; Wallace Clinic; 🇺🇸 Durham, North Carolina, United States