Pulmonary Rehabilitation Through Tele Rehabilitation for COPD in Pakistan

Sponsor
Riphah International University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05828602
Collaborator
(none)
40
1
2
3
13.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Conventional treatment
  • Other: TeleRehabilitation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Feasibility of Pulmonary Rehabilitation Through Tele Rehabilitation Versus Traditional Center Based Pulmonary Rehabilitation for COPD in Pakistan
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Conventional treatment

Other: Conventional treatment
Conventional treatment

Experimental: TeleRehabilitation

Other: TeleRehabilitation
TeleRehabilitation

Outcome Measures

Primary Outcome Measures

  1. Chronic respiratory questionnaire [40 Days]

    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)

  2. Physical activity via IPAQ [40 Days]

    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

  3. Quality of life - Sf 12 [40 Days]

    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

  4. Body mass index [40 Days]

    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

  5. Borg Scale [40 Days]

    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

  6. Level of satisfaction scale [40 Days]

    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

  7. Self-Structure open ended Questions [40 Days]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hayatabad Medical Complex Peshawar Khyber PkahtoonKhwa Pakistan

Sponsors and Collaborators

  • Riphah International University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05828602
Other Study ID Numbers:
  • Rec/01373 Mehwish Haider
First Posted:
Apr 25, 2023
Last Update Posted:
Apr 25, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 25, 2023