HealthyNCT04932733
Isometric Exercises in Healthy Elderly Individuals
A study testing Exercises and Young isometric exercise in people with Healthy, run by Salameh Aldaja at 1 site in Jordan.
Trial summary
A total of 58 participants were selected and divided into two groups equally, namely, elderly, and young groups with the age groups of 60-80 years and 20-30 years, respectively. The Heart Rate (HR), Respiratory Rate (RR), Blood Pressure (BP), Oxygen Saturation (SaO2), and Mean Arterial Pressure (MAP) for each… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exercises and Young isometric exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteJordan
- Study dates
- 15 Feb 2021to 1 Dec 2021
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The inclusion criteria were normotensive males and females in the above age groups.
Who cannot join
- Participants with a chronic history of alcohol, smoking, resting tachycardia (>100 beats per min), hypertension, history of any other cardiovascular disorders, any peripheral vascular disease, those on a regular exercise program, and uncooperative participants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Single Session of Knee Isometric Exercises on Blood Pressure in Healthy Elderly: A Clinical Controlled Trial
A total of 58 participants were selected and divided into two groups equally, namely, elderly, and young groups with the age groups of 60-80 years and 20-30 years, respectively. The Heart Rate (HR), Respiratory Rate (RR), Blood Pressure (BP), Oxygen Saturation (SaO2), and Mean Arterial Pressure (MAP) for each participant were assessed before and after the treatment session.
Read the detailed description
The elderly participants in the experimental group and the young participants in the control group underwent a single session of 5-minute quadriceps isometric exercise. The participant was asked to take rest of 10 minutes before performing the exercise. After that, the exercise was performed from a long-sitting position.
- Conditions
- Healthy
- Being tested
- Exercises, Young isometric exercise
- Keywords
- Blood pressure, Isometric exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExercisesOther
Also called Elderly isometric exercise
The elderly participants in the experimental group underwent a single session of 5-minute quadriceps isometric exercise. The participant was asked to take a rest of 10 minutes before performing the exercise. After that, the exercise was performed from a long-sitting position.
Young isometric exerciseOther
The young participants in the experimental group underwent a single session of 5-minute quadriceps isometric exercise. The participant was asked to take a rest of 10 minutes before performing the exercise. After that, the exercise was performed from a long-sitting position.
| Study group | Role | What they receive |
|---|---|---|
| Elderly isometric exercise | Experimental | Quadriceps isometric exercise. Receives: Other: Exercises |
| Young isometric exercise | Active comparator | Quadriceps isometric exercise. Receives: Other: Young isometric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure (BP)
Both systolic and diastolic blood pressures were measured by a trained physiotherapist in the right upper arm using an appropriate-sized cuff at the baseline and the end of the intervention using an automated Dinamap MPS Select device (Johnson \& Johnson, New Brunswick, NJ).
Measured: Change from baseline blood pressure at 1 day
Secondary outcomes (4)
Respiratory Rate (RR)
Respiratory rate was assessed by visually observe for 30 seconds and multiply observed breaths by 2 to obtain breaths per minute (BPM).
Measured: Change from baseline respiratory rate at 1 day
Oxygen Saturation (SaO2)
Oxygen saturation was recorded using a finger pulse oximeter. The sensor was placed on the right index finger, and the values were recorded after at least two minutes.
Measured: Change from baseline oxygen saturation at 1 day
Heart Rate (HR)
Heart rate was recorded using a finger pulse oximeter. The sensor was placed on the right index finger, and the values were recorded after at least two minutes.
Measured: Change from baseline heart rate at 1 day
Mean Arterial Pressure (MAP)
Mean arterial pressure was calculated MAP as diastolic blood pressure (DBP) + 1/3 [systolic blood pressure (SBP) - DBP].
Measured: Change from baseline mean arterial pressure at 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start15 Feb 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salameh Aldaja
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Salameh Aldaja, Isra University, Jordan
- Investigators
- Salameh Aldaja, PhD, Principal investigator, Isra University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932733
- Sponsor's protocol ID
- 337-1/1
- Status last verified
- Jan 2022
- First submitted
- 6 Jun 2021
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Single Session of Knee Isometric Exercises on Blood Pressure in Healthy Elderly: A Clinical Controlled Trial
- ClinicalTrials.gov ID
- NCT04932733
- Acronym / sponsor ID
- 337-1/1
- Conditions
- Healthy
- Keywords
- Blood pressure, Isometric exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Salameh AldajaUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 21 Jun 2021 (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.
A total of 58 participants were selected and divided into two groups equally, namely, elderly, and young groups with the age groups of 60-80 years and 20-30 years, respectively. The Heart Rate (HR), Respiratory Rate (RR), Blood Pressure (BP), Oxygen Saturation (SaO2), and Mean Arterial Pressure (MAP) for each participant were assessed before and after the treatment session.
Detailed description
The elderly participants in the experimental group and the young participants in the control group underwent a single session of 5-minute quadriceps isometric exercise. The participant was asked to take rest of 10 minutes before performing the exercise. After that, the exercise was performed from a long-sitting position.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly isometric exercise | Experimental | Other: ExercisesQuadriceps isometric exercise. |
| Young isometric exercise | Active comparator | Other: Young isometric exerciseQuadriceps isometric exercise. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria were normotensive males and females in the above age groups.
Key exclusion criteria (1 listed)
- Participants with a chronic history of alcohol, smoking, resting tachycardia (>100 beats per min), hypertension, history of any other cardiovascular disorders, any peripheral vascular disease, those on a regular exercise program, and uncooperative participants.
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 |
|---|---|---|
| ExercisesAlso: Elderly isometric exerciseThe elderly participants in the experimental group underwent a single session of 5-minute quadriceps isometric exercise. The participant was asked to take a rest of 10 minutes before performing the exercise. After that, the exercise was performed from a long-sitting position. | Other | Elderly isometric exercise |
| Young isometric exerciseThe young participants in the experimental group underwent a single session of 5-minute quadriceps isometric exercise. The participant was asked to take a rest of 10 minutes before performing the exercise. After that, the exercise was performed from a long-sitting position. | Other | Young isometric exercise |
Primary outcome
Blood Pressure (BP)
Time frame: Change from baseline blood pressure at 1 day
Both systolic and diastolic blood pressures were measured by a trained physiotherapist in the right upper arm using an appropriate-sized cuff at the baseline and the end of the intervention using an automated Dinamap MPS Select device (Johnson \& Johnson, New Brunswick, NJ).
4 secondary outcomes
Respiratory Rate (RR)
Time frame: Change from baseline respiratory rate at 1 day
Oxygen Saturation (SaO2)
Time frame: Change from baseline oxygen saturation at 1 day
Heart Rate (HR)
Time frame: Change from baseline heart rate at 1 day
Mean Arterial Pressure (MAP)
Time frame: Change from baseline mean arterial pressure at 1 day
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 25 Jan 2022.
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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.
Salameh Aldaja, PhD principal investigator
Isra 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 Exercises and Young isometric exercise in people with Healthy, run by Salameh Aldaja at 1 site in Jordan.
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 1 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 25 Jan 2022. 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 Jordan. 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?
Blood Pressure (BP) (time frame: Change from baseline blood pressure at 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2022.