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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Hypertension Post-Exercise Hypotension Resistance Training Other: Resistance training Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Set Volume of Optimal Resistance Exercise to Generate Hypotension in Hypertensive Elderly Subjects: a Crossover Study
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 3 sets of resistance exercise Other: Resistance training
3, 6 or 9 sets of biceps curl with elastic bands at 20 repetition-maximum (RM)
Experimental: 6 sets of resistance exercise Other: Resistance training
3, 6 or 9 sets of biceps curl with elastic bands at 20 repetition-maximum (RM)
Experimental: 9 sets of resistance exercise Other: Resistance training
3, 6 or 9 sets of biceps curl with elastic bands at 20 repetition-maximum (RM)
No Intervention: Rest


Outcome Measures
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Primary Outcome Measures :
  1. Blood pressure [ Time Frame: Baseline ]
  2. Blood pressure [ Time Frame: Immediately after the end of resistance training session ]
  3. Blood pressure [ Time Frame: 30 minutes after the end of resistance training session ]
  4. Blood pressure [ Time Frame: 60 minutes after the end of resistance training session ]
  5. Blood pressure [ Time Frame: 4 hours after the end of resistance training session ]
  6. Blood pressure [ Time Frame: 5 hours after the end of resistance training session ]
  7. Blood pressure [ Time Frame: 6 hours after the end of resistance training session ]

Secondary Outcome Measures :
  1. Heart rate [ Time Frame: Baseline ]
  2. Heart rate [ Time Frame: Immediately after the end of resistance training session ]
  3. Heart rate [ Time Frame: 30 minutes after the end of resistance training session ]
  4. Heart rate [ Time Frame: 60 minutes after the end of resistance training session ]
  5. Heart rate [ Time Frame: 4 hours after the end of resistance training session ]
  6. Heart rate [ Time Frame: 5 hours after the end of resistance training session ]
  7. Heart rate [ Time Frame: 6 hours after the end of resistance training session ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957746


Contacts
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Contact: Jose Casaña 656437371 jose.casana@uv.es
Contact: Joaquín Calatayud 625577509 joaquin.calatayud@uv.es

Locations
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Spain
Primary Health-Care Center Recruiting
Rocafort, Valencia, Spain, 46111
Contact: Jose C Granell, PhD    656437371    jose.casana@uv.es   
Contact: Joaquín Calatayud, PhD    625577509    joaquin.calatayud@uv.es   
Sponsors and Collaborators
University of Valencia
Investigators
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Principal Investigator: Jose Casaña University of Valencia
Study Chair: Joaquín Calatayud University of Valencia
Study Chair: Alba Cuerda University of Valencia
More Information
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Responsible Party: José Casaña Granell, Director, PhD, University of Valencia
ClinicalTrials.gov Identifier: NCT03957746     History of Changes
Other Study ID Numbers: 000018819
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Post-Exercise Hypotension
Hypotension
Vascular Diseases
Cardiovascular Diseases
 Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases