Effects of Neuromuscular Electrical Stimulation in Patients With Congestive Heart Failure
1 other identifier
interventional
15
1 country
1
Brief Summary
This study intends to treat patient with congestive heart failure that are maximized their pharmacological treatment and at heart transplant wait list. All patients in the treatment arm will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks. The outcome will be assessed by the improvement in quality of life and functional capacity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Sep 2012
Typical duration for not_applicable heart-failure
1 active site
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
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 27, 2013
CompletedFirst Posted
Study publicly available on registry
December 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 10, 2014
December 1, 2014
3.2 years
November 27, 2013
December 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement on distance walked in the six minute walk test
after 7 weeks of first inttervention
Secondary Outcomes (1)
Improvement on quality of life
7 weeks after first intervention
Study Arms (2)
Neuromuscular stimulation
EXPERIMENTALThe patients will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks.
Sham Group
PLACEBO COMPARATORThe patients will receive very low electric muscular stimulation with a no biological or clinical effects
Interventions
All patients in the treatment arm will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks.
Eligibility Criteria
You may qualify if:
- patients on waiting list for heart transplant
You may not qualify if:
- patients that won't accept to participate in the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Campinas
Campinas, São Paulo, 13100000, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Carolina Sacilotto, MsC
University of Campinas
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
November 27, 2013
First Posted
December 10, 2014
Study Start
September 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
December 10, 2014
Record last verified: 2014-12