ObeseNCT05865145
Effects of Aerobic Exercise on Basic Metabolic Panel Perceived Exertion and Exercise Adherence in Elderly
A study testing Electronic Bicycle Ergometer in people with Obese and Elderly, run by Rana Elbanna at 1 site in Egypt.
Trial summary
Participants were randomly assigned to two groups prior to their second visit: the High intensity interval training group A (HIIT) and Low intensity interval training group B (LIIT). The randomization processes were conducted in Excel utilizing a random-number generator. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- What is being tested?
- Electronic Bicycle Ergometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- May 2023to May 2023
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- could stand and walk for 30m without becoming out of breath.
- could walk safely without the aid of another person.
- body mass index (BMI) ≥ 30 kg/m2
Who cannot join
- uncontrolled preexisting health conditions such as:
- uncontrolled hypertension
- uncontrolled diabetes
- uncontrolled heart disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic faculty of physical therapy at Cairo University
Giza, 12613
Sherif O osama, PHD, 00201067227404, shiref.elabd@yahoo.com
About this study
Official title: Effects of Two Different Intensities of Aerobic Exercise on Basic Metabolic Panel Perceived Exertion and Exercise Adherence in Older Obese Adults
Participants were randomly assigned to two groups prior to their second visit:
the High intensity interval training group A (HIIT) and Low intensity interval training group B (LIIT).
The randomization processes were conducted in Excel utilizing a random-number generator. Prior to the second visit, each participants' target exercise heart rate ranges were determined.
Group A will receive a program of high intensity interval training program Group B will receive a program of Low intensity interval training program
- Being tested
- Electronic Bicycle Ergometer
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Bicycle ErgometerDevice
Electronic Bicycle equipped with electronic break, display screen, adjustable seat, handle bar and foot straps will be adjusted for High or Low interval intensity training.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | will receive High Intensity Interval Training program Receives: Device: Electronic Bicycle Ergometer |
| Group B | Experimental | will receive Low Intensity Interval Training program Receives: Device: Electronic Bicycle Ergometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Exertion
The Modified Borg Dyspnea Scale was used to assess perceived exertion during breathing. It was given after the first and final training sessions. The participants were asked to score their difficulty in breathing on a scale of 0 to 10, with 0 indicating no trouble in breathing at all and 10 indicating maximum difficulty in breathing
Measured: 4 weeks
Exercise Adherence
The Exercise Adherence Rating Scale (EARS) is a self-reported 16-item questionnaire that rates adherence to prescribed workouts. The EARS are divided into three components. The suggested exercise questionnaire is discussed in Section (A), Section (B) discusses exercise adherence behavior, and Section (C) discusses the factors for exercise adherence/non-adherence. All items in sections B and C are rated on a 5-point Likert scale (0 = fully agree to 4 = entirely disagree). Section 'B' favourably phrased items (items 1, 4, and 6) and Section 'C' positively phrased items (items 4, 5, 6, and 7) are assessed in reverse order. Sections "B" and "C" have possible total scores ranging from 0 to 24 and 0 to 40, respectively. The potential total score for parts (B) and (C) is 64. A higher total score suggests more adherence to exercise.
Measured: 4 weeks
Glucose level
blood test that examines Glucose level in (mmol/L)
Measured: 4 weeks
calcium level
blood test that examines calcium level in (mg/dL)
Measured: 4 weeks
sodium level
blood test that examines sodium level in (mmol/L)
Measured: 4 weeks
potassium level
blood test that examines potassium level in (millimol/L)
Measured: 4 weeks
carbon dioxide level
blood test that examines carbon dioxide level in parts per million (ppm)
Measured: 4 weeks
chloride level
blood test that examines chloride level in mmol/L
Measured: 4 weeks
blood urea nitrogen (BUN) level
blood test that examines blood urea nitrogen (BUN) level in (mg/dL)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study startMay 2023 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rana Elbanna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rana Elbanna, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865145
- Sponsor's protocol ID
- DR Rana
- Status last verified
- May 2023
- First submitted
- 5 Apr 2023
- Last updated
- 18 May 2023
- 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 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Different Intensities of Aerobic Exercise on Basic Metabolic Panel Perceived Exertion and Exercise Adherence in Older Obese Adults
- ClinicalTrials.gov ID
- NCT05865145
- Acronym / sponsor ID
- DR Rana
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rana ElbannaUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 18 May 2023 (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.
Participants were randomly assigned to two groups prior to their second visit:
the High intensity interval training group A (HIIT) and Low intensity interval training group B (LIIT).
The randomization processes were conducted in Excel utilizing a random-number generator. Prior to the second visit, each participants' target exercise heart rate ranges were determined.
Group A will receive a program of high intensity interval training program Group B will receive a program of Low intensity interval training program
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Electronic Bicycle Ergometerwill receive High Intensity Interval Training program |
| Group B | Experimental | Device: Electronic Bicycle Ergometerwill receive Low Intensity Interval Training program |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- could stand and walk for 30m without becoming out of breath.
- could walk safely without the aid of another person.
- body mass index (BMI) ≥ 30 kg/m2
Key exclusion criteria (4 listed)
- uncontrolled preexisting health conditions such as:
- uncontrolled hypertension
- uncontrolled diabetes
- uncontrolled heart disease
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 |
|---|---|---|
| Electronic Bicycle ErgometerElectronic Bicycle equipped with electronic break, display screen, adjustable seat, handle bar and foot straps will be adjusted for High or Low interval intensity training. | Device | Group A, Group B |
Primary outcome
Perceived Exertion
Time frame: 4 weeks
The Modified Borg Dyspnea Scale was used to assess perceived exertion during breathing. It was given after the first and final training sessions. The participants were asked to score their difficulty in breathing on a scale of 0 to 10, with 0 indicating no trouble in breathing at all and 10 indicating maximum difficulty in breathing
Exercise Adherence
Time frame: 4 weeks
The Exercise Adherence Rating Scale (EARS) is a self-reported 16-item questionnaire that rates adherence to prescribed workouts. The EARS are divided into three components. The suggested exercise questionnaire is discussed in Section (A), Section (B) discusses exercise adherence behavior, and Section (C) discusses the factors for exercise adherence/non-adherence. All items in sections B and C are rated on a 5-point Likert scale (0 = fully agree to 4 = entirely disagree). Section 'B' favourably phrased items (items 1, 4, and 6) and Section 'C' positively phrased items (items 4, 5, 6, and 7) are assessed in reverse order. Sections "B" and "C" have possible total scores ranging from 0 to 24 and 0 to 40, respectively. The potential total score for parts (B) and (C) is 64. A higher total score suggests more adherence to exercise.
Glucose level
Time frame: 4 weeks
blood test that examines Glucose level in (mmol/L)
calcium level
Time frame: 4 weeks
blood test that examines calcium level in (mg/dL)
sodium level
Time frame: 4 weeks
blood test that examines sodium level in (mmol/L)
potassium level
Time frame: 4 weeks
blood test that examines potassium level in (millimol/L)
carbon dioxide level
Time frame: 4 weeks
blood test that examines carbon dioxide level in parts per million (ppm)
chloride level
Time frame: 4 weeks
blood test that examines chloride level in mmol/L
blood urea nitrogen (BUN) level
Time frame: 4 weeks
blood test that examines blood urea nitrogen (BUN) level in (mg/dL)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Bicycle Ergometer in people with Obese and Elderly, run by Rana Elbanna at 1 site in Egypt.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 May 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rana H Elbanna, PHD (01062070686 ext. 002, rana.hesham@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Exertion (time frame: 4 weeks). The study lists 9 primary outcomes in all. 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 18 May 2023.