NCT03957746

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
12 months until next milestone

Study Start

First participant enrolled

May 13, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2021

Completed
Last Updated

October 5, 2021

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

May 16, 2019

Last Update Submit

October 4, 2021

Conditions

HypertensionPost-Exercise HypotensionResistance Training

Outcome Measures

Primary Outcomes (7)

  • Blood pressure

    Baseline

  • Blood pressure

    Immediately after the end of resistance training session

  • Blood pressure

    30 minutes after the end of resistance training session

  • Blood pressure

    60 minutes after the end of resistance training session

  • Blood pressure

    4 hours after the end of resistance training session

  • Blood pressure

    5 hours after the end of resistance training session

  • Blood pressure

    6 hours after the end of resistance training session

Secondary Outcomes (7)

  • Heart rate

    Baseline

  • Heart rate

    Immediately after the end of resistance training session

  • Heart rate

    30 minutes after the end of resistance training session

  • Heart rate

    60 minutes after the end of resistance training session

  • Heart rate

    4 hours after the end of resistance training session

  • +2 more secondary outcomes

Study Arms (4)

3 sets of resistance exercise

EXPERIMENTAL
Other: Resistance training

6 sets of resistance exercise

EXPERIMENTAL
Other: Resistance training

9 sets of resistance exercise

EXPERIMENTAL
Other: Resistance training

Rest

NO INTERVENTION

Interventions

Resistance trainingOTHER

3, 6 or 9 sets of biceps curl with elastic bands at 20 repetition-maximum (RM)

3 sets of resistance exercise6 sets of resistance exercise9 sets of resistance exercise

Eligibility Criteria

Age55 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Health-Care Center

Rocafort, Valencia, 46111, Spain

Location

Related Publications (1)

  • Gargallo P, Casana J, Suso-Marti L, Cuenca-Martinez F, Lopez-Bueno R, Andersen LL, Lopez-Bueno L, Cuerda-Del Pino A, Calatayud J. Minimal Dose of Resistance Exercise Required to Induce Immediate Hypotension Effect in Older Adults with Hypertension: Randomized Cross-Over Controlled Trial. Int J Environ Res Public Health. 2022 Oct 31;19(21):14218. doi: 10.3390/ijerph192114218.

    PMID: 36361100DERIVED

MeSH Terms

Conditions

HypertensionPost-Exercise Hypotension

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOrthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotension

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jose Casaña

    University of Valencia

    PRINCIPAL INVESTIGATOR

  • Joaquín Calatayud

    University of Valencia

    STUDY CHAIR

  • Alba Cuerda

    University of Valencia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, PhD

Study Record Dates

First Submitted

May 16, 2019

First Posted

May 21, 2019

Study Start

May 13, 2020

Primary Completion

October 1, 2020

Study Completion

October 3, 2021

Last Updated

October 5, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)