NCT05052047

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

October 10, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
Last Updated

February 2, 2022

Status Verified

February 1, 2022

Enrollment Period

3 months

First QC Date

September 18, 2021

Last Update Submit

February 1, 2022

Conditions

Keywords

Aerobic ExerciseBrisk WalkHealth-related quality of life

Outcome Measures

Primary Outcomes (6)

  • 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.

    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)

    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.

    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

    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

    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.

    4th week

Secondary Outcomes (1)

  • Quality of life: St. George's Respiratory Questionnaire (SGRQ)

    4th week

Study Arms (2)

Brisk Walking Group

EXPERIMENTAL

Brisk walking as training for 4 weeks

Other: Brisk Walking Group

Conventional Breathing Exercise Group

ACTIVE COMPARATOR

Conventional Breathing exercise for 4 weeks

Other: Conventional Breathing Exercise Group

Interventions

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

Brisk Walking Group

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

Conventional Breathing Exercise Group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • COPD patients (GOLD criteria Mild and Moderate).

You may not qualify if:

  • Dyspnea more than 4
  • Walking issues
  • Rheumatoid arthritis
  • Musculoskeletal disorder
  • Acute infections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Hospital Islamabad

Islamabad, Fedral, 46000, Pakistan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammad Iqbal Tariq, MSCPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2021

First Posted

September 22, 2021

Study Start

October 10, 2021

Primary Completion

January 20, 2022

Study Completion

January 20, 2022

Last Updated

February 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations