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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04927182
Other study ID # REC/00877 Nayab Saleem
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2020
Est. completion date September 30, 2021

Study information

Verified date October 2021
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

- To determine the impact of moderate exercise training on vitals (BP, HR) in different age categories of adult in COVID-19. - To determine the Impact of moderate exercise training on Peak VO2 in different age categories of adult in COVID-19 - To determine muscle discomfort due to physical training.


Description:

As of 30th January 2020, the outbreak of the novel coronavirus disease, later called COVID-19, was declared a Public Health Emergency. Governments' immediate protective measurements aim to slow down the ongoing spread of the COVID-19 disease. Coronavirus had infected people exponentially. It has a typical symptom of influenza which includes fever, cough, fatigue sore throat and additional symptoms like breathlessness and diarrhea. There was no specific treatment to cure it and no vaccination to prevent it from further progression. The solitary solution for prevent of this virus was isolation and no gathering, which has caused people to sit in their houses and wash hands. Literature shows that a significant larger reduction in Blood Pressure was observed in participant performing aerobic exercise. A study shows comparison between African and Asian population with hypertension indicates that Asian participant reduced more BP as compared to African .


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 17 Years and older
Eligibility Inclusion Criteria: - Cognitively intact - Age categories (Young adult 17 -30, Middle age adults 31 to 45, old Age Above 45) - SBP>120 mm Hg or DBP>80 mm Hg, and who had no physical limitations that precluded exercise participation were recruited from the general population from Pakistan in COVID era. - No Regular Exercise since MARCH 2020 (start of COVID era) 3 months at least. Exclusion Criteria: - Participant failing to fall in this category would be excluded of the study. - Uncontrolled hypertension - Major joint impairment - Bone fracture in the last 6 months - Asthmatic patients

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Moderate Exercise Training (Age Group 1; Young adult 17 -30 years)
Supervised Moderate exercise training will be given. This protocol consisted of 3 types of exercises. This includes walking/jogging/running for 23 minutes cycling for 23 minutes and stepping for 5 minutes. The protocol will be performed in 50 minutes sessions thrice a week.
Moderate Exercise Training (Age Group 2; 31 to 45 years)
Supervised Moderate exercise training will be given. This protocol consisted of 3 types of exercises. This includes walking/jogging/running for 23 minutes cycling for 23 minutes and stepping for 5 minutes. The protocol will be performed in 50 minutes sessions thrice a week.
Moderate Exercise Training (Age Group 3; Above 45 years)
Supervised Moderate exercise training will be given. This protocol consisted of 3 types of exercises. This includes walking/jogging/running for 23 minutes cycling for 23 minutes and stepping for 5 minutes. The protocol will be performed in 50 minutes sessions thrice a week.

Locations

Country Name City State
Pakistan General Population 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 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. 6th week
Primary Systolic and diastolic blood pressure Changes from the Baseline, Systolic Blood pressure (SBP) and Diastolic Blood Pressure (DBP) will be measured through sphygmomanometer 6th week
Primary Nordic Musculoskeletal questionnaire The Nordic Musculoskeletal Questionnaire (NMQ) quantifies musculoskeletal pain and activity prevention in 9 body regions. The Nordic general questionnaire is a standardized instrument used to analyse musculoskeletal symptoms in an ergonomic or occupational health context. The NMQ is comprised of just 3 questions regarding musculoskeletal pain including annual and 7-day prevalence of symptoms and annual prevention from normal work (at home or away from home). For each Question body region wise; Yes and No options are there to report. Patient can report more than 1 body region. 6th Week
Primary 6 Min walk test (Distance in meters) Changes from the baseline, 6 Min Walk Distance (6 MWD) 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. 6th Week
Primary Peak VO2 with formula A generalized equation can be used to determined peak VO2 (Peak rate of oxygen consumption). The generalized equation can be used to accurately estimate mean peak VO2 from mean 6 MWD, among groups of patients with diverse diseases without the need for cardiopulmonary exercise testing. The equation is:
Mean peak VO2(ml/kg/mins) = 4.948 + 0.023*Mean 6 MWD (meter) Changes From the Baseline will be measured
6th week
Primary Heart Rate/Pulse Rate Changes from baseline, Pulse rate was measured per minute through pulse oximeter. Crossly it was measure by Chest belt (Polar HR monitors). Changes from the Baseline will be measure. 6th week
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