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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05828602
Other study ID # Rec/01373 Mehwish Haider
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 20, 2023
Est. completion date July 1, 2023

Study information

Verified date July 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Conventional treatment
Conventional treatment
TeleRehabilitation
TeleRehabilitation

Locations

Country Name City State
Pakistan Hayatabad Medical Complex Peshawar Khyber PkahtoonKhwa

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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