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

NCT ID: NCT04741191

Last Updated: 2021-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2021-04-01

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.

Conditions

Heart Failure NYHA Class I; Heart Failure NYHA Class II

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cycle ergometer training

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

Group Type: EXPERIMENTAL

Cycle ergometer training

Intervention Type: OTHER

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 therapy

Patient education and counseling, In bed activities, Ambulation

Group Type: ACTIVE_COMPARATOR

Conventional therapy

Intervention Type: OTHER

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.

Interventions

Cycle ergometer training

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

Conventional therapy

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mehwish Waseem, MSPT(CPPT)

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Lady Reading Hospital,

Peshawar, KPK, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 26543861 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25592094 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16713337 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14729656 (View on PubMed)

Other Identifiers

Rec/00784 Irfan ullah

Identifier Type: -

Identifier Source: org_study_id