Heart Failure and Regional Specific Exercise Training Stimulus (HF-RSTS)

September 16, 2014 updated by: Duke University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Center for Living; Wallace Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject Adherence & Compliance
Time Frame: 4 Weeks
The number of training sessions attended and successfully completed divided by the total number of planned sessions
4 Weeks
One Repetition Maximum (1RM)
Time Frame: 4 Weeks
Skeletal muscle strength assessed using a one repetition maximum (1RM) measurement obtained for the seated row, chest press, leg press and handgrip.
4 Weeks
Senior Fitness Test
Time Frame: 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).
4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

February 28, 2014

First Submitted That Met QC Criteria

March 3, 2014

First Posted (Estimate)

March 4, 2014

Study Record Updates

Last Update Posted (Estimate)

September 17, 2014

Last Update Submitted That Met QC Criteria

September 16, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00051711

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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