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

Not Applicable

Completed

• Conditions: Heart Failure NYHA Class I; Heart Failure NYHA Class II
• Interventions: Other: Cycle ergometer training; Other: Conventional therapy

• Registration Number: NCT04741191
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-05
• Primary Completion: 2021-03-01
• Study Completion: 2021-04-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-19
• Last Update Posted: 2021-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cycle ergometer training	Cycle ergometer training	Hospital-based ergometer cycling for 20 minutes (Including warm-up and cooldown)
Conventional therapy	Conventional therapy	Patient education and counseling, In bed activities, Ambulation

Primary Outcome Measures

Name	Time	Method
Heart rate recovery	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.

Secondary Outcome Measures

Name	Time	Method
Mindfulness	6 weeks	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.

Trial Locations

Locations (1)

Lady Reading Hospital,; 🇵🇰 Peshawar, KPK, Pakistan