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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05059925
Other study ID # REC/01084 Anam Saif
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 25, 2021
Est. completion date August 30, 2022

Study information

Verified date October 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date August 30, 2022
Est. primary completion date August 30, 2022
Accepts healthy volunteers No
Gender All
Age group 30 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Structured gym activities
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)).
Traditional aerobic 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

Locations

Country Name City State
Pakistan Fitlytics gym Rawalpindi Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Pulse Rate Changes from baseline, Pulse rate was measured per minute through pulse oximeter 4th Week
Primary 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
Primary Systolic and diastolic blood pressure Changes from the Baseline, Blood pressure is measured through sphygmomanometer 4th week
Primary 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
Primary 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
Primary 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
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