Heart Rate VariabilityNCT03068182
Effects of Arm Crank Versus Treadmill Exercises on Heart Rate Variability in Adult Subjects.
A study testing Arm crank, Treadmill and Exercise in people with Heart Rate Variability, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 36 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Variability
- What is being tested?
- Arm crank, Treadmill and Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Sep 2015to 25 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 36 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Any participant had medical history of cardiovascular and pulmonary disorders or received any interfering medications with study was excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Responses to Arm Crank Exercise Versus to Treadmill Exercise in Adult Subjects
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.
Read the detailed description
A one hundred thirty male volunteers were equally and randomly assigned to; Group-I: Sixty-five participated in an arm crank moderate intensity exercise for 40 minutes. Group-II: Sixty-five participated in a treadmill moderate intensity exercise for 40 minutes. Halter heart rate monitor and automatic sphygmomanometer were used to measure heart beat intervals and arterial blood pressure respectively.
- Conditions
- Heart Rate Variability
- Being tested
- Arm crank, Treadmill, Exercise
- Keywords
- Exercise ,Autonomic cardiac function ,Adult subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Arm crank Exercise | Experimental | Sixty-five participated in an arm crank moderate intensity exercise for 40 minutes. Receives: Device: Arm crank; Other: Exercise |
| Treadmill Exercise | Experimental | Sixty-five participated in a treadmill moderate intensity exercise for 40 minutes. Receives: Device: Treadmill; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Autonomic functions of the heart was measured
Measured: 45 minutes
Secondary outcomes (1)
Blood pressure
Arm blood pressure was measured
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start1 Sep 2015
- Primary completion25 Sep 2016
- Study completion25 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Rate VariabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignments
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alsayed Abd Elhameed Shanb, Imam Abdulrahman Bin Faisal University
- Investigators
- Alsayed A Shanb, PhD, Principal investigator, Imam Abdulrahman Bin Faisal UniversityEnas F Youssef, PhD, Study director, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068182
- Sponsor's protocol ID
- 2015-03-159
- Status last verified
- Feb 2017
- First submitted
- 26 Feb 2017
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The final comment of our results only will be shared
Publications
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.
PubMed 24756637
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Responses to Arm Crank Exercise Versus to Treadmill Exercise in Adult Subjects
- ClinicalTrials.gov ID
- NCT03068182
- Acronym / sponsor ID
- 2015-03-159
- Conditions
- Heart Rate Variability
- Keywords
- Exercise ,Autonomic cardiac function ,Adult subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 25 Sep 2016 (actual)
- Study completion
- 25 Jan 2017 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A one hundred thirty male volunteers were equally and randomly assigned to; Group-I: Sixty-five participated in an arm crank moderate intensity exercise for 40 minutes. Group-II: Sixty-five participated in a treadmill moderate intensity exercise for 40 minutes. Halter heart rate monitor and automatic sphygmomanometer were used to measure heart beat intervals and arterial blood pressure respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel assignments
| Arm | Type | Receives |
|---|---|---|
| Arm crank Exercise | Experimental | Device: Arm crank, Other: ExerciseSixty-five participated in an arm crank moderate intensity exercise for 40 minutes. |
| Treadmill Exercise | Experimental | Device: Treadmill, Other: ExerciseSixty-five participated in a treadmill moderate intensity exercise for 40 minutes. |
Who may qualify
- Ages
- 25 to 36 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Any participant had medical history of cardiovascular and pulmonary disorders or received any interfering medications with study was excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm crankEach 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 | Device | Arm crank Exercise |
| TreadmillParticipant 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 | Device | Treadmill Exercise |
| Exercise | Other | Arm crank Exercise, Treadmill Exercise |
Primary outcome
Heart rate variability
Time frame: 45 minutes
Autonomic functions of the heart was measured
1 secondary outcome
Blood pressure
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Results publication: PubMed 24756637White 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.
- Description it is a scientific locationLink provided by the sponsor.
- Individual participant dataSharing planned: No. The final comment of our results only will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alsayed A Shanb, PhD principal investigator
Imam Abdulrahman Bin Faisal University
Enas F Youssef, PhD study director
Imam Abdulrahman Bin Faisal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm crank, Treadmill and Exercise in people with Heart Rate Variability, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03068182, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.