Impact of Moderate Exercise Training on Vitals and Peak VO2 in Different Age Categories of Adult in COVID-19.

• 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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Moderate Exercise Training (Age Group 1; Young adult 17 -30 years); Other: Moderate Exercise Training (Age Group 2; 31 to 45 years); Other: Moderate Exercise Training (Age Group 3; Above 45 years)

Detailed 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 .

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • General Population

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate Exercise Training (Age Group 1; Young adult 17 -30 years)	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.
Experimental: Moderate Exercise Training (Age Group 2; 31 to 45 years)	Other: 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.
Experimental: Moderate Exercise Training (Age Group 3; Above 45 years)	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: REC/00877 Nayab Saleem

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