Heart Failure and Regional Specific Exercise Training Stimulus

Heart Failure Clinical Trial

— HF-RSTS  

Official title:

Heart Failure and Regional Specific Exercise Training Stimulus

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02077426
• Other study ID #: Pro00051711
• Status: Withdrawn
• Phase: N/A
• First received: February 28, 2014
• Last updated: September 16, 2014
• Start date: June 2014

Study information

• Verified date: March 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Sedentary

Intervention

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.

Locations

Country	Name	City	State
United States	Duke Center for Living; Wallace Clinic	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject Adherence & Compliance	The number of training sessions attended and successfully completed divided by the total number of planned sessions	4 Weeks	No
Primary	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	No
Primary	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	No