NCT04615481

Brief Summary

To determine the effects of elliptical training versus ergo-meter on cardiopulmonary parameters in post CABG patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 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

September 8, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

November 3, 2020

Last Update Submit

January 12, 2021

Conditions

Keywords

Ergo-meterCABGEndurance

Outcome Measures

Primary Outcomes (6)

  • 6 min walk test: Distance (meters)

    Changes from the baseline, 6 min walk test was used to measure Functional capacity. It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min without any support.

    4th week

  • Oxygen Saturation (SpO2)

    Changes from baseline SPO2 was measured in percentage. Oxygen immersion is the division of oxygen-soaked hemoglobin with respect to add up to hemoglobin in the blood. Pulse oximeter measure it.

    4th week

  • Pulse Rate

    Changes from baseline, Pulse rate was measured per minute through pulse oximeter

    4th week

  • Modified Borg Scale of Perceived Exertion

    Changes from the Baseline, It is a subjective numeric scale ranging from 0 to 10, where 0 indicates "no dyspnea" and 10 indicates "unbearable dyspnea." A number is chosen by the patient in order to decide the best score that matches his level of dyspnea during physical activity.

    4th week

  • Systolic and diastolic blood pressure

    Changes from the Baseline, Blood pressure is measured through sphygmomanometer

    4th week

  • WHO_BREF questioner (Quality of life)

    Changes for the baseline, The World Health Organization (WHO) Quality of Life Group Developed a self-report 26 item questionnaire called the WHO Quality of Life Instrument, Short Form (WHOQOLBREF).the questioner is intend to assess the four aspect of quality of life physical (seven questions), psychological (six questions), social (three questions), and environmental (eight questions) dimensions.There are no cut-off points above or below which quality of life could be evaluated as "poor" or "good". Thus, it was decided to rationalize the analysis by defining two groups at the extremes, both in perception of QoL and satisfaction with health (good QoL /satisfied - includes those who reported having good or very good QoL and were satisfied or very satisfied with their health; and poor QoL /dissatisfied - includes those who reported poor or very poor QoL and who were dissatisfied or very dissatisfied with their health).

    4th week

Study Arms (2)

Elliptical Training Group

EXPERIMENTAL

Total 30 minutes of elliptical cross training, including warm up, progressive elliptical training and cool down.

Other: Elliptical Training Group

Ergo-metric Training Group

EXPERIMENTAL

Total 30 minutes of ergometric training

Other: Ergo-metric Training Group

Interventions

The training program will be consisted of total 30 minutes of elliptical cross training (5 minutes warm up + Progressive Training up to 20 minutes of elliptical cross training + 5 minutes cool down) for 3 days in a week for 4 weeks at an average intensity of 50-70% the maximal heart rate according to ACSM guidelines.

Elliptical Training Group

The training program will be consisted of total 30 minutes of ergometric training (5 minutes warm up + Progressive Training up to 10 minutes of upper limb ergometric training + Progressive Training up to 10 minutes of lower limb ergometric training+5 minutes cool down) for 3 days in a week for 4 weeks at an average intensity of 50-70% the maximal heart rate according to ACSM guidelines.

Ergo-metric Training Group

Eligibility Criteria

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

You may qualify if:

  • CABG patients (after 4 months) undergone phase 2 rehabilitation.

You may not qualify if:

  • Vitally Unstable patients
  • Presence of arrhythmias
  • History of unstable angina in last 3 months
  • Intracavitary thrombus
  • Recent thrombophlebitis with or without pulmonary embolism
  • Sever/e obstructive cardiomyopathies
  • Uncontrolled diabetes
  • Severe orthopaedic problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rawalpindi Institute of Cardiology

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (1)

  • Ab Manap N, Khalid KBMKM, Alias MNBA, Jamaludin NB. Quality of Life among Post Acute Myocardial Infarction Patient. ILKKM Journal of Medical and Health Sciences. 2019;1(1):20-4.

    BACKGROUND

Study Officials

  • Iqbal Tariq, MsCPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 4, 2020

Study Start

September 8, 2020

Primary Completion

December 20, 2020

Study Completion

December 20, 2020

Last Updated

January 13, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations