NCT03068182

Brief Summary

Cardiovascular response to exercise affects the capacity of all body organs depending upon intensity, duration and mode of exercises. The aim was to compare acute effects of arm crank with treadmill moderate intensity exercises on heart rate variability in normal participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

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

Study Start

First participant enrolled

September 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
Last Updated

August 8, 2017

Status Verified

February 1, 2017

Enrollment Period

1.1 years

First QC Date

February 26, 2017

Last Update Submit

August 6, 2017

Conditions

Heart Rate Variability

Keywords

Exercise ,Autonomic cardiac function ,Adult subjects

Outcome Measures

Primary Outcomes (1)

  • Heart rate variability

    Autonomic functions of the heart was measured

    45 minutes

Secondary Outcomes (1)

  • Blood pressure

    5 minutes

Study Arms (2)

Arm crank Exercise

EXPERIMENTAL

Sixty-five participated in an arm crank moderate intensity exercise for 40 minutes.

Device: Arm crankOther: Exercise

Treadmill Exercise

EXPERIMENTAL

Sixty-five participated in a treadmill moderate intensity exercise for 40 minutes.

Device: TreadmillOther: Exercise

Interventions

Arm crankDEVICE

Each participant practiced on arm crank (Hudson) from long sitting position for 40 minutes. Seat's height and distance were adjusted to achieve full extension of subject arms at horizontal shoulder-level position

Arm crank Exercise
TreadmillDEVICE

Participant practiced on an electronic computerized treadmill for 40 minutes . participant began warming up with lowest speed treadmill exercise for 5 minutes at zero inclination. Treadmill speed was increased gradually to achieve the pre-determined individualized moderate intensity for 30 minutes

Treadmill Exercise
ExerciseOTHER
Arm crank ExerciseTreadmill Exercise

Eligibility Criteria

Age25 Years - 36 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal adult non-obese male subjects , their age ranges from 25-36 years.
  • They were asymptomatic for cardiovascular and respiratory diseases.
  • They currently did not receive any medical prescriptions.
  • All participants were asked to avoid strenuous exercise, give up caffeine and alcohol beverages to have sufficient rest for 2 days before measurement sessions to avoid any carry over effects of stimulants or depressants on autonomic functions

You may not qualify if:

  • Any participant had medical history of cardiovascular and pulmonary disorders or received any interfering medications with study was excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Dammam

Dammam, Estern Pronince, 31441, Saudi Arabia

Location

Related Publications (1)

  • White DW, Raven PB. Autonomic neural control of heart rate during dynamic exercise: revisited. J Physiol. 2014 Jun 15;592(12):2491-500. doi: 10.1113/jphysiol.2014.271858. Epub 2014 Apr 22.

    PMID: 24756637RESULT

Related Links

MeSH Terms

Interventions

Exercise TestExercise

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative TechniquesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alsayed A Shanb, PhD

    Imam Abdulrahman Bin Faisal University

    PRINCIPAL INVESTIGATOR

  • Enas F Youssef, PhD

    Imam Abdulrahman Bin Faisal University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
by a blinded and independent research assistant who opened sealed envelopes that contained a computer-generated randomization card
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel assignments
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 26, 2017

First Posted

March 1, 2017

Study Start

September 1, 2015

Primary Completion

September 25, 2016

Study Completion

January 25, 2017

Last Updated

August 8, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

The final comment of our results only will be shared

Locations

SA(1)