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Set Volume of Optimal Resistance Exercise to Generate Hypotension

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ClinicalTrials.gov Identifier: NCT03957746
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
José Casaña Granell, University of Valencia

Tracking Information
First Submitted Date  ICMJE May 16, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date May 21, 2019
Actual Study Start Date  ICMJE May 13, 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
  • Blood pressure [ Time Frame: Baseline ]
  • Blood pressure [ Time Frame: Immediately after the end of resistance training session ]
  • Blood pressure [ Time Frame: 30 minutes after the end of resistance training session ]
  • Blood pressure [ Time Frame: 60 minutes after the end of resistance training session ]
  • Blood pressure [ Time Frame: 4 hours after the end of resistance training session ]
  • Blood pressure [ Time Frame: 5 hours after the end of resistance training session ]
  • Blood pressure [ Time Frame: 6 hours after the end of resistance training session ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
  • Heart rate [ Time Frame: Baseline ]
  • Heart rate [ Time Frame: Immediately after the end of resistance training session ]
  • Heart rate [ Time Frame: 30 minutes after the end of resistance training session ]
  • Heart rate [ Time Frame: 60 minutes after the end of resistance training session ]
  • Heart rate [ Time Frame: 4 hours after the end of resistance training session ]
  • Heart rate [ Time Frame: 5 hours after the end of resistance training session ]
  • Heart rate [ Time Frame: 6 hours after the end of resistance training session ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Set Volume of Optimal Resistance Exercise to Generate Hypotension
Official Title  ICMJE Set Volume of Optimal Resistance Exercise to Generate Hypotension in Hypertensive Elderly Subjects: a Crossover Study
Brief Summary This study evaluates the volume of optimal resistance exercise to generate postexercise hypotension after performing a single exercise in hypertensive elderly subjects. 20 subjects will perform 1 control session and 3 resistance training sessions with different volume: 3, 6 and 9 sets
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Post-Exercise Hypotension
  • Resistance Training
Intervention  ICMJE Other: Resistance training
3, 6 or 9 sets of biceps curl with elastic bands at 20 repetition-maximum (RM)
Study Arms  ICMJE
  • Experimental: 3 sets of resistance exercise
    Intervention: Other: Resistance training
  • Experimental: 6 sets of resistance exercise
    Intervention: Other: Resistance training
  • Experimental: 9 sets of resistance exercise
    Intervention: Other: Resistance training
  • No Intervention: Rest
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 16, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hypertensive subjects treated with antihypertensive medication
  • Controlled blood pressure
  • Age between 55 and 70 years old
  • Sedentary (less than 150 minutes per week of moderate physical activity and/or 75 minutes per week of vigorous physical activity)
  • Non-smokers
  • Non-alcoholics
  • Informed consent

Exclusion Criteria:

  • Any kidney, lung, neurological or psychiatric disease
  • Unable to perform exercises
  • Participation in other physical activity programs during the study or in the previous 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jose Casaña 656437371 jose.casana@uv.es
Contact: Joaquín Calatayud 625577509 joaquin.calatayud@uv.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03957746
Other Study ID Numbers  ICMJE 000018819
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party José Casaña Granell, University of Valencia
Study Sponsor  ICMJE University of Valencia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jose Casaña University of Valencia
Study Chair: Joaquín Calatayud University of Valencia
Study Chair: Alba Cuerda University of Valencia
PRS Account University of Valencia
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP