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

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Moderate Exercise Training (Age Group 1; Young adult 17 -30 years)
Moderate Exercise Training (Age Group 2; 31 to 45 years)
Moderate Exercise Training (Age Group 3; Above 45 years)
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Covid19

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • General Population

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Moderate Exercise Training (Age Group 1; Young adult 17 -30 years)

Moderate Exercise Training (Age Group 2; 31 to 45 years)

Moderate Exercise Training (Age Group 3; Above 45 years)

Arm Description

Outcomes

Primary Outcome Measures

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.
Systolic and diastolic blood pressure
Changes from the Baseline, Systolic Blood pressure (SBP) and Diastolic Blood Pressure (DBP) will be measured through sphygmomanometer
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.
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.
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
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.

Secondary Outcome Measures

Full Information

First Posted
June 14, 2021
Last Updated
October 19, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04927182
Brief Title
Impact of Moderate Exercise Training on Vitals and Peak VO2 in Different Age Categories of Adult in COVID-19.
Official Title
Impact of Moderate Exercise Training on Vitals and Peak VO2 in Different Age Categories of Adult in COVID-19.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate Exercise Training (Age Group 1; Young adult 17 -30 years)
Arm Type
Experimental
Arm Title
Moderate Exercise Training (Age Group 2; 31 to 45 years)
Arm Type
Experimental
Arm Title
Moderate Exercise Training (Age Group 3; Above 45 years)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Moderate Exercise Training (Age Group 1; Young adult 17 -30 years)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Moderate Exercise Training (Age Group 2; 31 to 45 years)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Moderate Exercise Training (Age Group 3; Above 45 years)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Borg Scale of Perceived Exertion
Description
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.
Time Frame
6th week
Title
Systolic and diastolic blood pressure
Description
Changes from the Baseline, Systolic Blood pressure (SBP) and Diastolic Blood Pressure (DBP) will be measured through sphygmomanometer
Time Frame
6th week
Title
Nordic Musculoskeletal questionnaire
Description
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.
Time Frame
6th Week
Title
6 Min walk test (Distance in meters)
Description
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.
Time Frame
6th Week
Title
Peak VO2 with formula
Description
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
Time Frame
6th week
Title
Heart Rate/Pulse Rate
Description
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.
Time Frame
6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Iqbal Tariq, MSCPPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Population
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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