NCT05059925

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

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

First Submitted

Initial submission to the registry

September 18, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

October 25, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

10 months

First QC Date

September 18, 2021

Last Update Submit

October 21, 2022

Conditions

Keywords

Gym ActivitiesAerobic Exercises

Outcome Measures

Primary Outcomes (8)

  • Quality of Life SF-36 questionnaire

    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)

    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

  • VO2 max

    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

    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

    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

Study Arms (2)

Structured gym activities

EXPERIMENTAL

Planned and structured activities such as Strength training for 4 weeks

Other: Structured gym activities

Traditional aerobic activities

ACTIVE COMPARATOR

Activities performed such as Treadmill , Cycle ergometer , Elliptical exercises for 4 weeks

Other: Traditional aerobic activities

Interventions

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)).

Structured gym activities

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

Traditional aerobic activities

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fitlytics gym Rawalpindi

Rawalpindi, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Muhammad Iqbal Tariq, MSCPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 18, 2021

First Posted

September 28, 2021

Study Start

October 25, 2021

Primary Completion

August 30, 2022

Study Completion

August 30, 2022

Last Updated

October 24, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations