NCT04741191

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

May 20, 2021

Status Verified

May 1, 2021

Enrollment Period

5 months

First QC Date

February 2, 2021

Last Update Submit

May 19, 2021

Conditions

Heart Failure NYHA Class IHeart Failure NYHA Class II

Keywords

Cycle ergometerHeart rate recoveryMindfulnessHeart Failure

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks

Secondary Outcomes (1)

  • Mindfulness

    6 weeks

Study Arms (2)

Cycle ergometer training

EXPERIMENTAL

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

Other: Cycle ergometer training

Conventional therapy

ACTIVE COMPARATOR

Patient education and counseling, In bed activities, Ambulation

Other: Conventional therapy

Interventions

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.

Cycle ergometer training
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.

Conventional therapy

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lady Reading Hospital,

Peshawar, KPK, 25000, Pakistan

Location

Related Publications (4)

  • 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.

    PMID: 26543861BACKGROUND

  • 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.

    PMID: 25592094BACKGROUND

  • 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.

    PMID: 16713337BACKGROUND

  • 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.

    PMID: 14729656BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Mehwish Waseem, MSPT(CPPT)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 5, 2021

Study Start

October 1, 2020

Primary Completion

March 1, 2021

Study Completion

April 1, 2021

Last Updated

May 20, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)