Structured Gym Activities and Aerobic Activities in People With Cardiac Conditions

October 21, 2022 updated by: Riphah International University

Compare the Effects of Structured Gym Activities and Traditional Aerobic Activities in People With Cardiac Conditions

To compare the effect of structured gym activities and traditional aerobic activities on cardiorespiratory endurance in people with cardiac conditions To compare the effect of structured gym activities and traditional aerobic activities on quality of life in people with cardiac conditions

Study Overview

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Punjab
      • Rawalpindi, Punjab, Pakistan, 44000
        • Fitlytics gym Rawalpindi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals with cardiac conditions including post-first myocardial infarction, post valvular diseases, post-CABG patients.
  • Individuals who can perform cardiorespiratory exercises with ease(who are able to complete 6 minute walk test).
  • Individuals who have not performed regular physical activity in the past 6 months (PA-R)
  • No regular exercise or gym activity since last 6 months

Exclusion Criteria:

  • Individuals who are highly trained in gymnastic
  • Already trained (any gym activity or regular exercise)
  • Individuals with Diabetes, hypertension, and kidney diseases.
  • Any neurological complication
  • Any Musculoskeletal Disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Structured gym activities
Planned and structured activities such as Strength training for 4 weeks

Planned and structured activities such as Strength training

  • Dumbbell Exercises (1kg with 2 sets of 10 repetitions)
  • Sit-ups (2 sets of 10 repetitions)
  • Stair climbing, (2 sets of 10 stairs up and down)
  • Squat (2 sets of 10 repetitions) Flexibility training • Tai chi (Peng. Lu, chi, an Tsai, lieh, chou, Kao (Hold each posture for 20 seconds)) • Pilates (Breathing., Shoulder bridge, Leg lifts (Hold each pose for 20 seconds)) • Stretching techniques (Neck stretch, Shoulder stretch, Side stretch Hold each stretch for 20 seconds)).
ACTIVE_COMPARATOR: Traditional aerobic activities
Activities performed such as Treadmill , Cycle ergometer , Elliptical exercises for 4 weeks

Activities performed such as

  • Treadmill Time: 10 minutes Intensity: 60 to 80% of target heart rate
  • Cycle ergometer Time: 10 minutes Intensity: 60 to 80% of target heart rate
  • Elliptical exercises Time: 10 minutes Intensity: 60 to 80% of target heart rate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life SF-36 questionnaire
Time Frame: Changes from the baseline to 4th Week

The Short Form 36 Health Survey Questionnaire (SF-36) questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). A final item, termed self-reported health transition, is answered by the client but is not included in the scoring process.

The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Changes from the baseline to 4th Week
Oxygen Saturation (SpO2)
Time Frame: 4th Week
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
Time Frame: 4th Week
Changes from baseline, Pulse rate was measured per minute through pulse oximeter
4th Week
Modified Borg Scale of Perceived Exertion
Time Frame: 4th week
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
Time Frame: 4th week
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
4th week
VO2 max
Time Frame: 4th week
Changes from the Baseline, Maximal oxygen consumption (VO2 max), refers to the maximum amount of oxygen that an individual can utilize during intense or maximal exercise.
4th week
METS
Time Frame: 4th Week

Changes from the Baseline, Metabolic equivalents (METS) Associated with Common Types of Endurance Exercise.

METs may be calculated during Standard Bruce Protocol by dividing oxygen uptake per minute with the product of 3.5 × bodyweight (kilograms)

4th Week
Quick Physical Activity Rating (QPAR) scale
Time Frame: 4th Week
10 items covering passive activities, walking, hobby and recreational activities, exercise, and housework with exemplars provided. Hobby activities, exercise and housework were further divided into light, moderate, and strenuous activities. Respondents were asked to consider these physical activities over the prior 4-week period. Each activity was weighted in intensity ranging from 1 (light) to 3 (heavy) intensity. Frequency of activity per week was collected as never (0 days), seldom (1-2 days), sometimes (3-4 days), and often (5-7 days). Duration of activity was collected as less than one hour per day, 1-2 hours per day, and more than two hours per day. Multiplication of the intensity (1-3), frequency (0-3) and duration (1-3) scores permitted calculation of a dose of physical activity ranging from 0-153. The QPAR took 3-5 minutes to complete. Changes from the baseline to 4th week
4th Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 25, 2021

Primary Completion (ACTUAL)

August 30, 2022

Study Completion (ACTUAL)

August 30, 2022

Study Registration Dates

First Submitted

September 18, 2021

First Submitted That Met QC Criteria

September 18, 2021

First Posted (ACTUAL)

September 28, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 24, 2022

Last Update Submitted That Met QC Criteria

October 21, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/01084 Anam Saif

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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