- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05052047
Brisk Walk on Chronic Obstructive Pulmonary Disease
Effects of 30 Min Brisk Walk on HRLQ and Pulmonary Functions on COPD Patients
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Fedral
-
Islamabad, Fedral, Pakistan, 46000
- Capital Hospital Islamabad
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- COPD patients (GOLD criteria Mild and Moderate).
Exclusion Criteria:
- Dyspnea more than 4
- Walking issues
- Rheumatoid arthritis
- Musculoskeletal disorder
- Acute infections.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Brisk Walking Group
Brisk walking as training for 4 weeks
|
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
|
ACTIVE_COMPARATOR: Conventional Breathing Exercise Group
Conventional Breathing exercise for 4 weeks
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
4th week
|
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.
|
4th week
|
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.
|
4th Week
|
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) |
4th Week
|
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. |
4th week
|
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
|
4th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life: St. George's Respiratory Questionnaire (SGRQ)
Time Frame: 4th week
|
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
|
4th week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- REC/01081 Shiza Zafar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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