NCT05828602

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

April 20, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

April 12, 2023

Last Update Submit

July 7, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (2)

Conventional treatment

ACTIVE COMPARATOR
Other: Conventional treatment

TeleRehabilitation

EXPERIMENTAL
Other: TeleRehabilitation

Interventions

Conventional treatment

Conventional treatment

TeleRehabilitation

TeleRehabilitation

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hayatabad Medical Complex

Peshawar, Khyber PkahtoonKhwa, Pakistan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Muhammad Iqbal Tariq, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 12, 2023

First Posted

April 25, 2023

Study Start

April 20, 2023

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

July 10, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations