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Cycle Ergometer Training and Heart Failure on Heart Rate Recovery and Mind Fullness

Primary Purpose

Heart Failure NYHA Class I, Heart Failure NYHA Class II

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Cycle ergometer training
Conventional therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure NYHA Class I focused on measuring Cycle ergometer, Heart rate recovery, Mindfulness, Heart Failure

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Vitally stable Patients with HF 6-8 weeks post-discharge from the hospital
  • NYHA class I, II
  • EF: 25-40%

Exclusion Criteria:

  • Arrhythmias /Regular Pvc/Permanent pacemaker/Tpm
  • Any systematic disease /infections
  • Uncontrolled DM/HTN
  • Unable to perform the 6-min walk test

Sites / Locations

  • Lady Reading Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cycle ergometer training

Conventional therapy

Arm Description

Hospital-based ergometer cycling for 20 minutes (Including warm-up and cooldown)

Patient education and counseling, In bed activities, Ambulation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 2, 2021
Last Updated
May 19, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04741191
Brief Title
Cycle Ergometer Training and Heart Failure on Heart Rate Recovery and Mind Fullness
Official Title
Effects of Cycle Ergometer Training on Heart Rate Recovery and Mind Fullness in NYHA Class I, II Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure NYHA Class I, Heart Failure NYHA Class II
Keywords
Cycle ergometer, Heart rate recovery, Mindfulness, Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cycle ergometer training
Arm Type
Experimental
Arm Description
Hospital-based ergometer cycling for 20 minutes (Including warm-up and cooldown)
Arm Title
Conventional therapy
Arm Type
Active Comparator
Arm Description
Patient education and counseling, In bed activities, Ambulation
Intervention Type
Other
Intervention Name(s)
Cycle ergometer training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heart rate recovery
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Mindfulness
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Vitally stable Patients with HF 6-8 weeks post-discharge from the hospital NYHA class I, II EF: 25-40% Exclusion Criteria: Arrhythmias /Regular Pvc/Permanent pacemaker/Tpm Any systematic disease /infections Uncontrolled DM/HTN Unable to perform the 6-min walk test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehwish Waseem, MSPT(CPPT)
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lady Reading Hospital,
City
Peshawar
State/Province
KPK
ZIP/Postal Code
25000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26543861
Citation
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.
Results Reference
background
PubMed Identifier
25592094
Citation
Yaylali 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.
Results Reference
background
PubMed Identifier
16713337
Citation
van 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.
Results Reference
background
PubMed Identifier
14729656
Citation
Piepoli 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.
Results Reference
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Cycle Ergometer Training and Heart Failure on Heart Rate Recovery and Mind Fullness

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