NCT02077426

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

September 17, 2014

Status Verified

March 1, 2014

Enrollment Period

2 years

First QC Date

February 28, 2014

Last Update Submit

September 16, 2014

Conditions

Heart FailureSedentary

Keywords

Functional CapacityExercise IndependencePeripheralStrength

Outcome Measures

Primary Outcomes (3)

  • Subject Adherence & Compliance

    The number of training sessions attended and successfully completed divided by the total number of planned sessions

    4 Weeks

  • 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.

    4 Weeks

  • 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).

    4 Weeks

Study Arms (1)

Regional Specific Training (RSTS)

EXPERIMENTAL

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)

Interventions

Regional Specific Training (RSTS)OTHER

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.

Regional Specific Training (RSTS)

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Center for Living; Wallace Clinic

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Heart FailureSedentary Behavior

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Jason D Allen, PhD

    Duke University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2014

First Posted

March 4, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2016

Last Updated

September 17, 2014

Record last verified: 2014-03

Locations

US(1)