COPDNCT05052047
Brisk Walk on Chronic Obstructive Pulmonary Disease
A study testing Brisk Walking Group and Conventional Breathing Exercise Group in people with COPD, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of 30 min brisk walk on Pulmonary Functions on COPD patients To determine the effects of 30 min brisk walk on Health related Health-related quality of life (HRLQ) on Chronic obstructive pulmonary disease (COPD) patients Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- COPD
- What is being tested?
- Brisk Walking Group and Conventional Breathing Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Oct 2021to 20 Jan 2022
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- COPD patients (GOLD criteria Mild and Moderate).
Who cannot join
- Dyspnea more than 4
- Walking issues
- Rheumatoid arthritis
- Musculoskeletal disorder
- Acute infections.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of 30 Min Brisk Walk on HRLQ and Pulmonary Functions on COPD Patients
To determine the effects of 30 min brisk walk on Pulmonary Functions on COPD patients To determine the effects of 30 min brisk walk on Health related Health-related quality of life (HRLQ) on Chronic obstructive pulmonary disease (COPD) patients
- Conditions
- COPD
- Being tested
- Brisk Walking Group, Conventional Breathing Exercise Group
- Keywords
- Aerobic Exercise, Brisk Walk, Health-related quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brisk Walking GroupOther
Brisk Walk: 20 min/day (The researchers found, for most people, brisk walking could be defined as moving at a pace of 2.7 miles per hour or 100 steps per minute for adults under about age 60 or guidelines define brisk walking as occurring when individuals move at a pace that increases their heart rate to about 70% of their heart rate maximum) Patient will also perform breathing exercises as given to Control group, Positioning (lean forward when needed) Percussion coughing when needed
Conventional Breathing Exercise GroupOther
Breathing exercises: 20 min/day
Breathing Ex includes:
- Pursed lip breathing: Sit with your back straight, inhale through your nose for 2 seconds. Purse your lips like you rae blowing on hot food and then breath out slowly, take twice as long to exhale as you took to breath in 4-5 times a day
- Diaphragmatic breathing: Lie on your back on a flat surface, knees bent and head supported. Use pillow under knees to support your legs . breathe in slowly through your nose tighten your stomach, letting them fall inward as you exhale through your pursed lips. Practice these exercises 5-10 minutes about 3-4 times a day.
Positioning (lean forward when needed) Percussion coughing when needed
| Study group | Role | What they receive |
|---|---|---|
| Brisk Walking Group | Experimental | Brisk walking as training for 4 weeks Receives: Other: Brisk Walking Group |
| Conventional Breathing Exercise Group | Active comparator | Conventional Breathing exercise for 4 weeks Receives: Other: Conventional Breathing Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 min walk test: Distance (meters)
Changes from the baseline, 6 min walk test 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: 4th Week
Peak VO2max with formula
Changes from the baseline, Maximal oxygen uptake or capacity is the maximum rate of oxygen consumed and measured during the stress activity. Its measurement within the laboratory demonstrates a numerical value for endurance fitness full stop and this value can be used to compare individuals training with or without diseases. This tool reflects cardiopulmonary endurance in the performance of any exercise. maximal oxygen consumption (VO2 max) is calculated by:
Mean Peak VO2 (ml/kg/Mean) = 4.948 + 0.023 *Mean 6MWD (meters)
6 minute walk distance (6MWD)
Measured: 4th Week
Health-related quality of life scale (HRLQ)
Changes from the baseline, It is usually administer the Health-Related Quality of Life scale verbally, reading the questions aloud and writing down respondents' answers.
The scale consists of three modules. The Core Healthy Days module contains one item that asks respondents to rate their general health on a 5-point scale (1 = excellent; 3 = good; 5 = poor). The module also has three items that ask respondents how many days their physical health was not good, their mental health was not good, and their health interfered with their daily activities.
It compute an unhealthy days score by adding the number of physically unhealthy and mentally unhealthy days. The maximum score is 30 unhealthy days, even if the number of unhealthy days totals more than 30.
Measured: 4th week
Forced Expiratory Volume in 1 second (FEV1)
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Measured: 4th week
Forced vital Capacity (FVC)
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
Measured: 4th week
Peak Expiratory Flow (PEF)
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
Measured: 4th week
Secondary outcomes (1)
Quality of life: St. George's Respiratory Questionnaire (SGRQ)
It is used to access the quality of life; SGRQ is used for determining quality of life in COPD patients. This questionnaire is designed in 50 items to check the impact of COPD. 0 to 100 is the range of this score. Scores having higher values means more limitations
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start10 Oct 2021
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- 74 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
- NCT05052047
- Sponsor's protocol ID
- REC/01081 Shiza Zafar
- Status last verified
- Feb 2022
- First submitted
- 18 Sep 2021
- Last updated
- 2 Feb 2022
- 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 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 30 Min Brisk Walk on HRLQ and Pulmonary Functions on COPD Patients
- ClinicalTrials.gov ID
- NCT05052047
- Acronym / sponsor ID
- REC/01081 Shiza Zafar
- Conditions
- COPD
- Keywords
- Aerobic Exercise, Brisk Walk, Health-related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 22 Sep 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 effects of 30 min brisk walk on Pulmonary Functions on COPD patients To determine the effects of 30 min brisk walk on Health related Health-related quality of life (HRLQ) on Chronic obstructive pulmonary disease (COPD) patients
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brisk Walking Group | Experimental | Other: Brisk Walking GroupBrisk walking as training for 4 weeks |
| Conventional Breathing Exercise Group | Active comparator | Other: Conventional Breathing Exercise GroupConventional Breathing exercise for 4 weeks |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- COPD patients (GOLD criteria Mild and Moderate).
Key exclusion criteria (5 listed)
- Dyspnea more than 4
- Walking issues
- Rheumatoid arthritis
- Musculoskeletal disorder
- Acute infections.
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 |
|---|---|---|
| Brisk Walking GroupBrisk Walk: 20 min/day (The researchers found, for most people, brisk walking could be defined as moving at a pace of 2.7 miles per hour or 100 steps per minute for adults under about age 60 or guidelines define brisk walking as occurring when individuals move at a pace that increases their heart rate to about 70% of their heart rate maximum) Patient will also perform breathing exercises as given to Control group, Positioning (lean forward when needed) Percussion coughing when needed | Other | Brisk Walking Group |
| Conventional Breathing Exercise GroupBreathing exercises: 20 min/day Breathing Ex includes: • Pursed lip breathing: Sit with your back straight, inhale through your nose for 2 seconds. Purse your lips like you rae blowing on hot food and then breath out slowly, take twice as long to exhale as you took to breath in 4-5 times a day • Diaphragmatic breathing: Lie on your back on a flat surface, knees bent and head supported. Use pillow under knees to support your legs . breathe in slowly through your nose tighten your stomach, letting them fall inward as you exhale through your pursed lips. Practice these exercises 5-10 minutes about 3-4 times a day. Positioning (lean forward when needed) Percussion coughing when needed | Other | Conventional Breathing Exercise Group |
Primary outcome
6 min walk test: Distance (meters)
Time frame: 4th Week
Changes from the baseline, 6 min walk test 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 VO2max with formula
Time frame: 4th Week
Changes from the baseline, Maximal oxygen uptake or capacity is the maximum rate of oxygen consumed and measured during the stress activity. Its measurement within the laboratory demonstrates a numerical value for endurance fitness full stop and this value can be used to compare individuals training with or without diseases. This tool reflects cardiopulmonary endurance in the performance of any exercise. maximal oxygen consumption (VO2 max) is calculated by: Mean Peak VO2 (ml/kg/Mean) = 4.948 + 0.023 *Mean 6MWD (meters) 6 minute walk distance (6MWD)
Health-related quality of life scale (HRLQ)
Time frame: 4th week
Changes from the baseline, It is usually administer the Health-Related Quality of Life scale verbally, reading the questions aloud and writing down respondents' answers. The scale consists of three modules. The Core Healthy Days module contains one item that asks respondents to rate their general health on a 5-point scale (1 = excellent; 3 = good; 5 = poor). The module also has three items that ask respondents how many days their physical health was not good, their mental health was not good, and their health interfered with their daily activities. It compute an unhealthy days score by adding the number of physically unhealthy and mentally unhealthy days. The maximum score is 30 unhealthy days, even if the number of unhealthy days totals more than 30.
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 4th week
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze Forced Expiratory Volume in 1 second FEV1 in Liters
Forced vital Capacity (FVC)
Time frame: 4th week
Changes From the Baseline, the digital spirometer is used in clinical setting to analyze Forced vital Capacity in Liters
Peak Expiratory Flow (PEF)
Time frame: 4th week
Changes from the Baseline, the digital spirometer is used in clinical setting to analyze peak expiratory flow PEF in Liter/second.
1 secondary outcome
Quality of life: St. George's Respiratory Questionnaire (SGRQ)
Time frame: 4th week
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 2 Feb 2022.
- 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 Brisk Walking Group and Conventional Breathing Exercise Group in people with COPD, 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 1 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 2 Feb 2022. 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?
6 min walk test: Distance (meters) (time frame: 4th 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 2 Feb 2022.