Covid19NCT04927182
Impact of Moderate Exercise Training on Vitals and Peak VO2 in Different Age Categories of Adult in COVID-19.
A study testing Moderate Exercise Training (Age Group 1; Young adult 17 -30 years), Moderate Exercise Training (Age Group 2; 31 to 45 years) and Moderate Exercise Training (Age Group 3; Above 45 years) in people with Covid19, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Moderate Exercise Training (Age Group 1; Young adult 17 -30 years), Moderate Exercise Training (Age Group 2; 31 to 45 years) and Moderate Exercise Training (Age Group 3; Above 45 years)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
- 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.
Read the 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 .
- Conditions
- Covid19
- Being tested
- 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)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Exercise Training (Age Group 1; Young adult 17 -30 years)Other
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)Other
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)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Moderate Exercise Training (Age Group 1; Young adult 17 -30 years) | Experimental | Not described Receives: Other: Moderate Exercise Training (Age Group 1; Young adult 17 -30 years) |
| Moderate Exercise Training (Age Group 2; 31 to 45 years) | Experimental | Not described Receives: Other: Moderate Exercise Training (Age Group 2; 31 to 45 years) |
| Moderate Exercise Training (Age Group 3; Above 45 years) | Experimental | Not described Receives: Other: Moderate Exercise Training (Age Group 3; Above 45 years) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start15 Oct 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Iqbal Tariq, MSCPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927182
- Sponsor's protocol ID
- REC/00877 Nayab Saleem
- Status last verified
- Oct 2021
- First submitted
- 14 Jun 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Moderate Exercise Training on Vitals and Peak VO2 in Different Age Categories of Adult in COVID-19.
- ClinicalTrials.gov ID
- NCT04927182
- Acronym / sponsor ID
- REC/00877 Nayab Saleem
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 15 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moderate Exercise Training (Age Group 1; Young adult 17 -30 years) | Experimental | Other: Moderate Exercise Training (Age Group 1; Young adult 17 -30 years) |
| Moderate Exercise Training (Age Group 2; 31 to 45 years) | Experimental | Other: Moderate Exercise Training (Age Group 2; 31 to 45 years) |
| Moderate Exercise Training (Age Group 3; Above 45 years) | Experimental | Other: Moderate Exercise Training (Age Group 3; Above 45 years) |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Moderate Exercise Training (Age Group 1; Young adult 17 -30 years) |
| 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. | Other | Moderate Exercise Training (Age Group 2; 31 to 45 years) |
| 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. | Other | Moderate Exercise Training (Age Group 3; Above 45 years) |
Primary outcome
Modified Borg Scale of Perceived Exertion
Time frame: 6th week
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
Time frame: 6th week
Changes from the Baseline, Systolic Blood pressure (SBP) and Diastolic Blood Pressure (DBP) will be measured through sphygmomanometer
Nordic Musculoskeletal questionnaire
Time frame: 6th Week
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)
Time frame: 6th Week
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
Time frame: 6th week
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
Time frame: 6th week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Iqbal Tariq, MSCPPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Exercise Training (Age Group 1; Young adult 17 -30 years), Moderate Exercise Training (Age Group 2; 31 to 45 years) and Moderate Exercise Training (Age Group 3; Above 45 years) in people with Covid19, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Borg Scale of Perceived Exertion (time frame: 6th week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.