Effect of Different Types of Aerobic Training on Diastolic Heart Failure PatientsNCT05637125
Effect of Different Types of Aerobic Training on Peak VO2 and Ejection Fraction for Diastolic Heart Failure Patients; a Comparative Randomized Control Trial
A study testing aerobic exercise for upper limb and aerobic exercise for lower limb in people with Effect of Different Types of Aerobic Training on Diastolic Heart Failure Patients, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Background: Heart failure is described by a lack of confirmed efficient therapies and exercise intolerance. Physical activity is related to a lower risk of adverse cardiovascular consequences, involving heart failure. Read more about this study
- Who is it for?
- Ages 50 to 65 years, men only
- Conditions the study is for
- Effect of Different Types of Aerobic Training on Diastolic Heart Failure Patients
- What is being tested?
- aerobic exercise for upper limb and aerobic exercise for lower limb
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 1 Jan 2022
- 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 50 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male gender
- under complete medical supervision
- left ventricular end diastolic dimension >5.5cm
- ejection fraction <50%.
Who cannot join
- Orthopedic problems
- Mental disorders
- Metabolic disorders (D.M)
- Current treatment for cancer or active infection.
Trial locations and contacts
1 site in 1 country.
About this study
Background: Heart failure is described by a lack of confirmed efficient therapies and exercise intolerance. Physical activity is related to a lower risk of adverse cardiovascular consequences, involving heart failure. The purpose of the study: determine the effect of different types of aerobic training on peak VO2 and ejection fraction in diastolic heart failure patients. Subject and methods: Forty eligible male patients with diastolic heart failure, aged between 50 - 60 years old, participated in this study. They were selected from an outpatient clinic of general Zagazig hospital and were assigned into 2 equal groups in numbers. The first group (A) received aerobic exercise for the upper limb in form of arm ergometer exercises, while the second group (B) received aerobic exercise for the lower limb in form of cycling. Training duration for both groups was 3 sessions/week for 12 weeks. Peak VO2, and ejection fraction of both groups were measured and compared pre and post-treatment. Results: There was no significant difference in the ejection fraction between groups post-treatment. There was a significant increase in the peak VO2 of group B compared with that of group A post-treatment. Conclusion: there is no effect of different types of aerobic training on ejection fraction and peak VO2 for diastolic heart failure patients, but lower limb exercise is more effective than upper limb exercise in improvement of peak VO2 for diastolic heart failure patients.
Read the detailed description
Ejection fraction and peak VO2 of both groups were measured pre exercise program and after 12 weeks at the end of the study exercise program.
- Vivid S5 cardiovascular ultrasound system (BT308), made in china, was used to measure ejection fraction.
- Oxycon pro (ER900, Germany) cardiopulmonary exercise test unit was used to measure Peak Vo2
Treatment procedure:
Group A received aerobic exercise for upper limb in the form of arm ergometer 3 session/week for 12 weeks. Patient started with warming up for 5 minutes in form of stretching. Patients used arm ergometer without resistance for upper limb aerobic exercise for 20 minutes and instructed to take rest if they feel tired or fatigue. The intensity was according to rate of perceive exertion, after 20 minutes, patients were asked to cool down for 5 minutes in the form of stretching at the end of an exercise session.
Group B received aerobic exercise for lower limb in the form of cycling 3session/week for 12 weeks. Patient started with warming up for 5 minutes. Patients used bicycle for lower limb aerobic exercise for 20 minutes and instructed to take rest if they feel tired or fatigue. The intensity was according to rate of perceive exertion. After 20 minutes, patients were asked to cool down for 5 minutes in the form of stretching at the end of an exercise session.
- Being tested
- aerobic exercise for upper limb, aerobic exercise for lower limb
- Keywords
- Diastolic heart failure, ejection fraction, aerobic exercise, peak VO2
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exercise for upper limbOther
aerobic exercise for upper limb in the form of arm ergometer 3 session/week for 12 weeks. Patient started with warming up for 5 minutes in form of stretching. Patients used arm ergometer without resistance for upper limb aerobic exercise for 20 minutes and instructed to take rest if they feel tired or fatigue. The intensity was according to rate of perceive exertion, after 20 minutes, patients were asked to cool down for 5 minutes in the form of stretching at the end of an exercise session.
aerobic exercise for lower limbOther
received aerobic exercise for lower limb in the form of cycling 3session/week for 12 weeks. Patient started with warming up for 5 minutes. Patients used bicycle for lower limb aerobic exercise for 20 minutes and instructed to take rest if they feel tired or fatigue. The intensity was according to rate of perceive exertion. After 20 minutes, patients were asked to cool down for 5 minutes in the form of stretching at the end of an exercise session.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A received aerobic exercise for upper limb in the form of arm ergometer 3 session/week for 12 weeks. Receives: Other: aerobic exercise for upper limb |
| Group B | Active comparator | received aerobic exercise for lower limb in the form of cycling 3session/week for 12 weeks. Receives: Other: aerobic exercise for lower limb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ejection fraction
Vivid S5 cardiovascular ultrasound system (BT308), made in china, was used to measure ejection fraction.
Measured: 12 weeks
peak VO2
Oxycon pro (ER900, Germany) cardiopulmonary exercise test unit was used to measure Peak Vo2
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Aug 2021
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
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 Effect of Different Types of Aerobic Training on Diastolic Heart Failure PatientsStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Ibrahim Abo Elyazed, Beni-Suef University
- Investigators
- Tamer Abo Elyazed, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637125
- Sponsor's protocol ID
- BeniSuefU2
- Status last verified
- Nov 2022
- First submitted
- 24 Nov 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Obaya HE, El-Moneim Abd El-Hakim AA, Fares HM, Eldin Saad MK, Abo Elyazed TI. Effect of different types of aerobic training on peak VO2 and ejection fraction for diastolic heart failure patients; a comparative randomized control trial. Physiother Res Int. 2024 Jan;29(1):e2044. doi: 10.1002/pri.2044. Epub 2023 Aug 3.
PubMed 37537847
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Types of Aerobic Training on Peak VO2 and Ejection Fraction for Diastolic Heart Failure Patients; a Comparative Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05637125
- Acronym / sponsor ID
- BeniSuefU2
- Keywords
- Diastolic heart failure, ejection fraction, aerobic exercise, peak VO2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 5 Dec 2022 (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.
Background: Heart failure is described by a lack of confirmed efficient therapies and exercise intolerance. Physical activity is related to a lower risk of adverse cardiovascular consequences, involving heart failure. The purpose of the study: determine the effect of different types of aerobic training on peak VO2 and ejection fraction in diastolic heart failure patients. Subject and methods: Forty eligible male patients with diastolic heart failure, aged between 50 - 60 years old, participated in this study. They were selected from an outpatient clinic of general Zagazig hospital and were assigned into 2 equal groups in numbers. The first group (A) received aerobic exercise for the upper limb in form of arm ergometer exercises, while the second group (B) received aerobic exercise for the lower limb in form of cycling. Training duration for both groups was 3 sessions/week for 12 weeks. Peak VO2, and ejection fraction of both groups were measured and compared pre and post-treatment. Results: There was no significant difference in the ejection fraction between groups post-treatment. There was a significant increase in the peak VO2 of group B compared with that of group A post-treatment. Conclusion: there is no effect of different types of aerobic training on ejection fraction and peak VO2 for diastolic heart failure patients, but lower limb exercise is more effective than upper limb exercise in improvement of peak VO2 for diastolic heart failure patients.
Detailed description
Ejection fraction and peak VO2 of both groups were measured pre exercise program and after 12 weeks at the end of the study exercise program.
- Vivid S5 cardiovascular ultrasound system (BT308), made in china, was used to measure ejection fraction.
- Oxycon pro (ER900, Germany) cardiopulmonary exercise test unit was used to measure Peak Vo2
Treatment procedure:
Group A received aerobic exercise for upper limb in the form of arm ergometer 3 session/week for 12 weeks. Patient started with warming up for 5 minutes in form of stretching. Patients used arm ergometer without resistance for upper limb aerobic exercise for 20 minutes and instructed to take rest if they feel tired or fatigue. The intensity was according to rate of perceive exertion, after 20 minutes, patients were asked to cool down for 5 minutes in the form of stretching at the end of an exercise session.
Group B received aerobic exercise for lower limb in the form of cycling 3session/week for 12 weeks. Patient started with warming up for 5 minutes. Patients used bicycle for lower limb aerobic exercise for 20 minutes and instructed to take rest if they feel tired or fatigue. The intensity was according to rate of perceive exertion. After 20 minutes, patients were asked to cool down for 5 minutes in the form of stretching at the end of an exercise session.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: aerobic exercise for upper limbGroup A received aerobic exercise for upper limb in the form of arm ergometer 3 session/week for 12 weeks. |
| Group B | Active comparator | Other: aerobic exercise for lower limbreceived aerobic exercise for lower limb in the form of cycling 3session/week for 12 weeks. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male gender
- under complete medical supervision
- left ventricular end diastolic dimension >5.5cm
- ejection fraction <50%.
Key exclusion criteria (4 listed)
- Orthopedic problems
- Mental disorders
- Metabolic disorders (D.M)
- Current treatment for cancer or active infection.
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 |
|---|---|---|
| aerobic exercise for upper limbaerobic exercise for upper limb in the form of arm ergometer 3 session/week for 12 weeks. Patient started with warming up for 5 minutes in form of stretching. Patients used arm ergometer without resistance for upper limb aerobic exercise for 20 minutes and instructed to take rest if they feel tired or fatigue. The intensity was according to rate of perceive exertion, after 20 minutes, patients were asked to cool down for 5 minutes in the form of stretching at the end of an exercise session. | Other | Group A |
| aerobic exercise for lower limbreceived aerobic exercise for lower limb in the form of cycling 3session/week for 12 weeks. Patient started with warming up for 5 minutes. Patients used bicycle for lower limb aerobic exercise for 20 minutes and instructed to take rest if they feel tired or fatigue. The intensity was according to rate of perceive exertion. After 20 minutes, patients were asked to cool down for 5 minutes in the form of stretching at the end of an exercise session. | Other | Group B |
Primary outcome
Ejection fraction
Time frame: 12 weeks
Vivid S5 cardiovascular ultrasound system (BT308), made in china, was used to measure ejection fraction.
peak VO2
Time frame: 12 weeks
Oxycon pro (ER900, Germany) cardiopulmonary exercise test unit was used to measure Peak Vo2
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 Dec 2022.
- Derived from this study: PubMed 37537847Obaya HE, El-Moneim Abd El-Hakim AA, Fares HM, Eldin Saad MK, Abo Elyazed TI. Effect of different types of aerobic training on peak VO2 and ejection fraction for diastolic heart failure patients; a comparative randomized control trial. Physiother Res Int. 2024 Jan;29(1):e2044. doi: 10.1002/pri.2044. Epub 2023 Aug 3.
- Individual participant dataSharing planned: No
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.
Tamer Abo Elyazed principal investigator
Beni-Suef 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 aerobic exercise for upper limb and aerobic exercise for lower limb in people with Effect of Different Types of Aerobic Training on Diastolic Heart Failure Patients, run by Beni-Suef University 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 4 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: finished, as of the sponsor's last update on 5 Dec 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 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?
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?
Ejection fraction (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT05637125, 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 5 Dec 2022.