Heart Failure NYHA Class INCT04741191
Cycle Ergometer Training and Heart Failure on Heart Rate Recovery and Mind Fullness
A study testing Cycle ergometer training and Conventional therapy in people with Heart Failure NYHA Class I and Heart Failure NYHA Class II, run by Riphah International University at 1 site in Pakistan.
Trial summary
To evaluate the effects of cycle ergometer training on heart rate recovery in Newyork Heart Association (NYHA) class I and II heart patients. To evaluate the effects of cycle ergometer training on mind fullness in NYHA class I and II heart patients. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Heart Failure NYHA Class I, Heart Failure NYHA Class II
- What is being tested?
- Cycle ergometer training and Conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2020to 1 Apr 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Vitally stable Patients with HF 6-8 weeks post-discharge from the hospital
- NYHA class I, II
- EF: 25-40%
Who cannot join
- Arrhythmias /Regular Pvc/Permanent pacemaker/Tpm
- Any systematic disease /infections
- Uncontrolled DM/HTN
- Unable to perform the 6-min walk test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cycle Ergometer Training on Heart Rate Recovery and Mind Fullness in NYHA Class I, II Heart Failure Patients
To evaluate the effects of cycle ergometer training on heart rate recovery in Newyork Heart Association (NYHA) class I and II heart patients. To evaluate the effects of cycle ergometer training on mind fullness in NYHA class I and II heart patients. Previous studies were designed to target only cardiac functions and no psychological aspect was studied so this study cover this aspect as well so from the outcomes of this study we can determine both psychological satisfaction and cardiac function as well.
Read the detailed description
A review stated that "clinical and experimental data shows that physical training is an important aspect in the management of chronic heart failure patients. Also, it stated that physical exercise training plays an important role to modulate peripheral immune responses if congestive heart failure (CHF) patients show high pro-inflammatory cytokines, soluble cellular adhesion molecules, which further resulted in an improvement in exercise capacity in CHF patients.
Heart rate recovery (HRR) improved in patients who were enrolled in the cardiac rehabilitation stage 2 program while similar outcomes were not noted among the control group. It was concluded that cardiac rehabilitation exercise program improves heart rate recovery. Also, HRR may be used in a cardiac rehabilitation program to recognize high risk factors and also useful in evaluating the outcomes.
a systematic review about the effects of exercise training in patients with CHF was published who concluded that short-term physical exercise training in selected subgroups of patients with CHF, has physiological benefits and positive effects on quality of life.
A meta-analysis by the Collaborative Group concluded that there is no evidence that supervised medical training programs for patients with CHF are dangerous and indeed there is clear evidence of an overall reduction in mortality. The authors did not perform a quantitative analysis on the outcome of cardiac performance, exercise capacity, or quality of life.
- Being tested
- Cycle ergometer training, Conventional therapy
- Keywords
- Cycle ergometer, Heart rate recovery, Mindfulness, Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycle ergometer trainingOther
Hospital-based ergometer cycling for 20 minutes (Including warm-up and cooldown), 3x/week on alternate days for 6 weeks at 40-60% of VO2max.
Conventional therapyOther
In bed activities (Active ankle and hand pumping exercise* 15 Rep* BD AROMS of extremities* 15 Rep* BD, Deep breathing exercises* 15 Rep* BD, Ambulation (walk 10-15 minutes below fatigue and onset of symptoms level* BD) for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cycle ergometer training | Experimental | Hospital-based ergometer cycling for 20 minutes (Including warm-up and cooldown) Receives: Other: Cycle ergometer training |
| Conventional therapy | Active comparator | Patient education and counseling, In bed activities, Ambulation Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate recovery
Changes from the baseline will be measured after every intervention session. Heart rate recovery is normally measured at 1, 2 or 3-minute intervals, with 1-minute HRR being the one that is most commonly used. For example, if your heart rate is 170 beats per minute when you finish working out, and then it drops to 150 bpm a minute later, your HRR is 20 bpm.
Measured: 6 weeks
Secondary outcomes (1)
Mindfulness
A mental state achieved by focusing one's awareness on the present moment, while calmly acknowledging and accepting one's feelings, thoughts, and bodily sensations, used as a therapeutic technique. It is measured through a scale that assesses characteristics of mindfulness which consist of 15-items. It assesses the present situation, perception or attention of mind, to observe what is going to happen, and sensitive awareness of what is occurring in the present.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 Oct 2020
- Primary completion1 Mar 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart Failure NYHA Class IStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehwish Waseem, MSPT(CPPT), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741191
- Sponsor's protocol ID
- Rec/00784 Irfan ullah
- Status last verified
- May 2021
- First submitted
- 2 Feb 2021
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hsu CY, Hsieh PL, Hsiao SF, Chien MY. Effects of Exercise Training on Autonomic Function in Chronic Heart Failure: Systematic Review. Biomed Res Int. 2015;2015:591708. doi: 10.1155/2015/591708. Epub 2015 Oct 12.
PubMed 26543861Yaylali YT, Findikoglu G, Yurtdas M, Konukcu S, Senol H. The effects of baseline heart rate recovery normality and exercise training protocol on heart rate recovery in patients with heart failure. Anatol J Cardiol. 2015 Sep;15(9):727-34. doi: 10.5152/akd.2014.5710. Epub 2014 Oct 15.
PubMed 25592094van Tol BA, Huijsmans RJ, Kroon DW, Schothorst M, Kwakkel G. Effects of exercise training on cardiac performance, exercise capacity and quality of life in patients with heart failure: a meta-analysis. Eur J Heart Fail. 2006 Dec;8(8):841-50. doi: 10.1016/j.ejheart.2006.02.013. Epub 2006 May 18.
PubMed 16713337Piepoli MF, Davos C, Francis DP, Coats AJ; ExTraMATCH Collaborative. Exercise training meta-analysis of trials in patients with chronic heart failure (ExTraMATCH). BMJ. 2004 Jan 24;328(7433):189. doi: 10.1136/bmj.37938.645220.EE. Epub 2004 Jan 16.
PubMed 14729656
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cycle Ergometer Training on Heart Rate Recovery and Mind Fullness in NYHA Class I, II Heart Failure Patients
- ClinicalTrials.gov ID
- NCT04741191
- Acronym / sponsor ID
- Rec/00784 Irfan ullah
- Keywords
- Cycle ergometer, Heart rate recovery, Mindfulness, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 5 Feb 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.
To evaluate the effects of cycle ergometer training on heart rate recovery in Newyork Heart Association (NYHA) class I and II heart patients. To evaluate the effects of cycle ergometer training on mind fullness in NYHA class I and II heart patients. Previous studies were designed to target only cardiac functions and no psychological aspect was studied so this study cover this aspect as well so from the outcomes of this study we can determine both psychological satisfaction and cardiac function as well.
Detailed description
A review stated that "clinical and experimental data shows that physical training is an important aspect in the management of chronic heart failure patients. Also, it stated that physical exercise training plays an important role to modulate peripheral immune responses if congestive heart failure (CHF) patients show high pro-inflammatory cytokines, soluble cellular adhesion molecules, which further resulted in an improvement in exercise capacity in CHF patients.
Heart rate recovery (HRR) improved in patients who were enrolled in the cardiac rehabilitation stage 2 program while similar outcomes were not noted among the control group. It was concluded that cardiac rehabilitation exercise program improves heart rate recovery. Also, HRR may be used in a cardiac rehabilitation program to recognize high risk factors and also useful in evaluating the outcomes.
a systematic review about the effects of exercise training in patients with CHF was published who concluded that short-term physical exercise training in selected subgroups of patients with CHF, has physiological benefits and positive effects on quality of life.
A meta-analysis by the Collaborative Group concluded that there is no evidence that supervised medical training programs for patients with CHF are dangerous and indeed there is clear evidence of an overall reduction in mortality. The authors did not perform a quantitative analysis on the outcome of cardiac performance, exercise capacity, or quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cycle ergometer training | Experimental | Other: Cycle ergometer trainingHospital-based ergometer cycling for 20 minutes (Including warm-up and cooldown) |
| Conventional therapy | Active comparator | Other: Conventional therapyPatient education and counseling, In bed activities, Ambulation |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Vitally stable Patients with HF 6-8 weeks post-discharge from the hospital
- NYHA class I, II
- EF: 25-40%
Key exclusion criteria (4 listed)
- Arrhythmias /Regular Pvc/Permanent pacemaker/Tpm
- Any systematic disease /infections
- Uncontrolled DM/HTN
- Unable to perform the 6-min walk test
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 |
|---|---|---|
| Cycle ergometer trainingHospital-based ergometer cycling for 20 minutes (Including warm-up and cooldown), 3x/week on alternate days for 6 weeks at 40-60% of VO2max. | Other | Cycle ergometer training |
| Conventional therapyIn bed activities (Active ankle and hand pumping exercise* 15 Rep* BD AROMS of extremities* 15 Rep* BD, Deep breathing exercises* 15 Rep* BD, Ambulation (walk 10-15 minutes below fatigue and onset of symptoms level* BD) for 6 weeks. | Other | Conventional therapy |
Primary outcome
Heart rate recovery
Time frame: 6 weeks
Changes from the baseline will be measured after every intervention session. Heart rate recovery is normally measured at 1, 2 or 3-minute intervals, with 1-minute HRR being the one that is most commonly used. For example, if your heart rate is 170 beats per minute when you finish working out, and then it drops to 150 bpm a minute later, your HRR is 20 bpm.
1 secondary outcome
Mindfulness
Time frame: 6 weeks
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 20 May 2021.
- Background: PubMed 26543861Hsu CY, Hsieh PL, Hsiao SF, Chien MY. Effects of Exercise Training on Autonomic Function in Chronic Heart Failure: Systematic Review. Biomed Res Int. 2015;2015:591708. doi: 10.1155/2015/591708. Epub 2015 Oct 12.
- Background: PubMed 25592094Yaylali YT, Findikoglu G, Yurtdas M, Konukcu S, Senol H. The effects of baseline heart rate recovery normality and exercise training protocol on heart rate recovery in patients with heart failure. Anatol J Cardiol. 2015 Sep;15(9):727-34. doi: 10.5152/akd.2014.5710. Epub 2014 Oct 15.
- Background: PubMed 16713337van Tol BA, Huijsmans RJ, Kroon DW, Schothorst M, Kwakkel G. Effects of exercise training on cardiac performance, exercise capacity and quality of life in patients with heart failure: a meta-analysis. Eur J Heart Fail. 2006 Dec;8(8):841-50. doi: 10.1016/j.ejheart.2006.02.013. Epub 2006 May 18.
- Background: PubMed 14729656Piepoli MF, Davos C, Francis DP, Coats AJ; ExTraMATCH Collaborative. Exercise training meta-analysis of trials in patients with chronic heart failure (ExTraMATCH). BMJ. 2004 Jan 24;328(7433):189. doi: 10.1136/bmj.37938.645220.EE. Epub 2004 Jan 16.
- Individual participant dataSharing planned: No
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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.
Mehwish Waseem, MSPT(CPPT) 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 Cycle ergometer training and Conventional therapy in people with Heart Failure NYHA Class I and Heart Failure NYHA Class II, 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 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 20 May 2021. 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?
Heart rate recovery (time frame: 6 weeks). 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 NCT04741191, which also lists 4 linked publications.
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 20 May 2021.