Pulmonary Rehabilitation Through Tele Rehabilitation for COPD in Pakistan

Feasibility of Pulmonary Rehabilitation Through Tele Rehabilitation Versus Traditional Center Based Pulmonary Rehabilitation for COPD in Pakistan

To determine the feasibility of Tele-rehabilitation vs traditional center-based pulmonary rehabilitation for people with chronic obstructive pulmonary disease

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: Conventional treatment; Other: TeleRehabilitation

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Khyber PkahtoonKhwa
    • Peshawar, Khyber PkahtoonKhwa, Pakistan
      • Hayatabad Medical Complex

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• have a primary diagnosis of a chronic obstructive pulmonary disease
• aged ≥40 years
• be able to read and speak Urdu
• Vitally stable
• both gender

Exclusion Criteria:

• Inability to use technology, inadequate home setting, and patient's refusal.
• pulmonary hypertension or lung cancer attended pulmonary rehabilitation within the previous 18 months and had no hospitalizations for a respiratory cause since rehabilitation completion
• oxygen desaturation resulting in cessation of cardiopulmonary exercise testing (e.g. SpO2 < 80% during exercise on cycle ergometer)
• to ensure safety of unsupervised training
• unstable or brittle asthma with a hospital admission or emergency department presentation within the preceding 3 months, to ensure safety of unsupervised training
• co-morbidities which preclude exercise training, such as neurological or musculoskeletal impairment
• unable to follow verbal instructions, suffer from cognitive impairment, or have language difficulties

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional treatment	Other: Conventional treatment; Conventional treatment
Experimental: TeleRehabilitation	Other: TeleRehabilitation; TeleRehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic respiratory questionnaire	The chronic respiratory questionnaire has 20 items spread over four domains: dyspnea (5 items), tiredness (4 items), emotional function (7 items), and mastery. It can be administered by an interviewer or self-administered (4 items). Patients complete a 7-point rating scale on this form, with 1 being the worst possible experience and 7 being the best possible one (no impairment)	40 Days
Physical activity via IPAQ	Any voluntary skeletal muscle-driven movement that involves an energy cost is referred to as physical activity. All activities, regardless of intensity or time of day or night, can be considered physical activity. Both physical activity and unplanned activities incorporated into everyday routines are included . International Physical Activity Questionnaire short from will be utilized to measure level of physical activity. It consists of 7 items which ask about the activity of the last 7 days	40 Days
Quality of life - Sf 12	The World Health Organization defines quality of life as "a person's view of their place in life in relation to their objectives, aspirations, standards, and concerns in the context of the culture and value systems in which they live." (20) . QOL will be assess via SF-12 Questionnaire. The SF-12 is a self-reported outcome measure that evaluates how one's health affects their day-to-day activities	40 Days
Body mass index	The body mass index (BMI) is a measurement that is based on a person's height and weight. The BMI is calculated by dividing the body weight by the square of the height, and it is expressed in kilograms per square meter (kg/m2) since weight is measured in kilograms and height is measured in meters	40 Days
Borg Scale	It is generally recognised that the Borg rating of perceived exertion scale is a reliable tool for determining perceived effort for a range of exercise modalities. The Borg scale (6-20) is intended to provide you with an approximation of your degree of effort based on your real heart rate when exercising. To determine your predicted heart rate, multiply your RPE by 10	40 Days
Level of satisfaction scale	It is a question that ranges from one extreme attitude to another using a 5 or 7- point scale that is sometimes referred to as a satisfaction scale. Very satisfied, Satisfied, Neither satisfied nor unsatisfied, Dissatisfied, and Very dissatisfied are examples of common responses on a 5-point Likert scale used to gauge satisfaction	40 Days
Self-Structure open ended Questions	Self-structured questionnaire was designed after reviewing the literature and with the help of experts in the field. it includes open ended questions, These questions will be asked in interview form from both the groups i.e Traditional Center Based Pulmonary Rehabilitation group and Tele Rehabilitation group, in which views on exercise, disease education, social contact, activity, accessibility, and support for participation will be assessed. This self-structured questionnaire will be a type of cognitive interview from both the groups.	40 Days

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Muhammad Iqbal Tariq, PhD*, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Rec/01373 Mehwish Haider

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No