Heart FailureNCT05948371
High Intensity Aerobic Interval Training Versus Continuous Training in Heart Failure Patients.
A study testing High Intensity interval Training and Continuous Aerobic training in people with Heart Failure, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effect of high intensity aerobic interval training versus continuous aerobic training in heart failure patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- High Intensity interval Training and Continuous Aerobic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2023to 15 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with heart failure including both male and female
- Patients who can perform 6 MWT.
- According to classification of American heart association, class 1 heart failure patients are included.
Who cannot join
- Heart failure patients along with orthopedic problems.
- Patients who have use pacemaker.
- Patient who have recent acute myocardial infraction or revascularization less than 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High Intensity Aerobic Interval Training Versus Continuous Training in Heart Failure Patients.
To determine the effect of high intensity aerobic interval training versus continuous aerobic training in heart failure patients.
- Conditions
- Heart Failure
- Being tested
- High Intensity interval Training, Continuous Aerobic training
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity interval TrainingOther
High Intensity interval Training
- Frequency: 3-5 day per week
- Intensity: 60 to 80% of HRR. If atrial fibrillation present use RPE of 11-14 on a 6-20 scale.
- Time: total 30 mint time.6 mint exercise with high intensity and 2 mints of low intensity for active recovery until 30 mints complete.
Type: walking and static cycling. Walking
- Frequency 3 -5 days per week Intensity : use RPE of 11-14.
- Time:30 mint total. 6 mint walk with high intensity and 2 mint walk with low intensity until 30mints completed.
Continuous Aerobic trainingOther
Continuous Aerobic training
- Frequency : 3-5 days per week.
- Intensity:40-70% of HHR.
- Time : initial 5-10 then 10-15 until 30mints without rest interval
- Type : walking and static cycling.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity interval Training | Experimental | Not described Receives: Other: High Intensity interval Training |
| Continuous Aerobic training | Active comparator | Not described Receives: Other: Continuous Aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
6MWT Distance
Changes from the baseline, 6 min walk test was used to measure Functional capacity. It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min.
Measured: 8 week
Minnesota living with heart failure questionnaire
MLWHFQ is commonly used health related quality of life questionnaires with heart failure. This is very easy to apply on patients and self-administered questionnaire. It has two components emotional and physical and total score. Each item is scored in a 6.likert scale (0 to 5), thus, the total score could range from 5 to 105, with higher scores indicating more significant impairment in health related quality of life. Changes from the basline will be measured
Measured: 8 week
Pulse Rate
Changes from baseline, Pulse rate was measured per minute through pulse oximeter
Measured: 8 week
Oxygen Saturation (SpO2)
Changes from baseline SPO2 was measured in percentage. Oxygen immersion is the division of oxygen-soaked hemoglobin with respect to add up to hemoglobin in the blood. Pulse oximeter measure it.
Measured: 8 week
Modified Borg dyspnea scale
Changes from the Baseline, It is a subjective numeric scale ranging from 0 to 10, where 0 indicates "no dyspnea" and 10 indicates "unbearable dyspnea." A number is chosen by the patient in order to decide the best score that matches his level of dyspnea during physical activity.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Sep 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Iqbal Tariq, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948371
- Sponsor's protocol ID
- REC/01653 Hafiza Misbah Inayat
- Status last verified
- Mar 2024
- First submitted
- 7 Jul 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Intensity Aerobic Interval Training Versus Continuous Training in Heart Failure Patients.
- ClinicalTrials.gov ID
- NCT05948371
- Acronym / sponsor ID
- REC/01653 Hafiza Misbah Inayat
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 17 Jul 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.
To determine the effect of high intensity aerobic interval training versus continuous aerobic training in heart failure patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity interval Training | Experimental | Other: High Intensity interval Training |
| Continuous Aerobic training | Active comparator | Other: Continuous Aerobic training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with heart failure including both male and female
- Patients who can perform 6 MWT.
- According to classification of American heart association, class 1 heart failure patients are included.
Key exclusion criteria (3 listed)
- Heart failure patients along with orthopedic problems.
- Patients who have use pacemaker.
- Patient who have recent acute myocardial infraction or revascularization less than 3 months.
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 |
|---|---|---|
| High Intensity interval TrainingHigh Intensity interval Training * Frequency: 3-5 day per week * Intensity: 60 to 80% of HRR. If atrial fibrillation present use RPE of 11-14 on a 6-20 scale. * Time: total 30 mint time.6 mint exercise with high intensity and 2 mints of low intensity for active recovery until 30 mints complete. Type: walking and static cycling. Walking * Frequency 3 -5 days per week Intensity : use RPE of 11-14. * Time:30 mint total. 6 mint walk with high intensity and 2 mint walk with low intensity until 30mints completed. | Other | High Intensity interval Training |
| Continuous Aerobic trainingContinuous Aerobic training * Frequency : 3-5 days per week. * Intensity:40-70% of HHR. * Time : initial 5-10 then 10-15 until 30mints without rest interval * Type : walking and static cycling. | Other | Continuous Aerobic training |
Primary outcome
6MWT Distance
Time frame: 8 week
Changes from the baseline, 6 min walk test was used to measure Functional capacity. It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min.
Minnesota living with heart failure questionnaire
Time frame: 8 week
MLWHFQ is commonly used health related quality of life questionnaires with heart failure. This is very easy to apply on patients and self-administered questionnaire. It has two components emotional and physical and total score. Each item is scored in a 6.likert scale (0 to 5), thus, the total score could range from 5 to 105, with higher scores indicating more significant impairment in health related quality of life. Changes from the basline will be measured
Pulse Rate
Time frame: 8 week
Changes from baseline, Pulse rate was measured per minute through pulse oximeter
Oxygen Saturation (SpO2)
Time frame: 8 week
Changes from baseline SPO2 was measured in percentage. Oxygen immersion is the division of oxygen-soaked hemoglobin with respect to add up to hemoglobin in the blood. Pulse oximeter measure it.
Modified Borg dyspnea scale
Time frame: 8 week
Changes from the Baseline, It is a subjective numeric scale ranging from 0 to 10, where 0 indicates "no dyspnea" and 10 indicates "unbearable dyspnea." A number is chosen by the patient in order to decide the best score that matches his level of dyspnea during physical activity.
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 5 Mar 2024.
- Individual participant dataSharing planned: No
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HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
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Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
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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.
Muhammad Iqbal Tariq, PhD* principal investigator
Riphah International 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 High Intensity interval Training and Continuous Aerobic training in people with Heart Failure, run by Riphah International University at 1 site in Pakistan.
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 3 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 5 Mar 2024. 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 Pakistan. 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?
6MWT Distance (time frame: 8 week). The study lists 5 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 5 Mar 2024.