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NCT Number: NCT04741191

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

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.

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Key information

Conditions

Heart Failure NYHA Class I Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure NYHA Class II

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lady Reading Hospital,

Peshawar, KPK, 25000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cycle ergometer training

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mindfulness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Cycle Ergometer Training on Heart Rate Recovery and Mind Fullness in NYHA Class I, II Heart Failure Patients

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2021
Registry last updated
May 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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