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Rethinking Pulmonary Rehabilitation (REPORT)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
pulmonary tele-rehabilitation (PTR)
home-based pulmonary rehabilitation (HPR)
Control
Sponsored by
Copenhagen University Hospital, Hvidovre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Indication for pulmonary rehabilitation according to Danish national guidelines Unable to access and participate in the conventional out-patient hospital- or community-based PR when offered during routine consultation A post-bronchodilator ratio FEV1/FVC <70% (confirmed physician diagnosis of COPD) A post-bronchodilator FEV1 <80% (degree of airway obstruction) corresponding to GOLD grade 2-4 (moderate to very severe) GOLD group B, C, D corresponding to severe respiratory symptoms and/or frequent acute exacerbations Able to stand up from a chair (height 44-46cm) and walk 10 meters independently (with or without a walking aid) Able to lift both arms to a horizontal level with a minimum of 1 kilogram's dumbbells in each hand Exclusion Criteria: Participation in conventional PR in the past 24 months Cognitive impairment - unable to follow instructions Impaired hearing or vision - unable to see or hear instruction from a tablet Unable to understand and speak Danish Comorbidities where the exercise content is contraindicated (e.g. treatment for diabetic foot ulcer, active cancer treatment, life expectancy <12-months)

Sites / Locations

  • Copenhagen University Hospital AmagerRecruiting
  • Copenhagen University Hospital Bispebjerg-FrederiksbergRecruiting
  • Copenhagen University Hospital Herlve-GentofteRecruiting
  • Copenhagen University Hospital GlostrupRecruiting
  • Copenhagen University Hospital NordsjaellandRecruiting
  • Copenhagen University Hospital HvidovreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

pulmonary tele-rehabilitation (PTR)

home-based pulmonary rehabilitation (HPR)

Control

Arm Description

Recieve supervised PTR 2/weekly, session duration of 60 min; 35 min of exercise and 25min of patient education for 10-weeks (primary endpoint). Delivered from Hvidovre/Bispebjerg Hospital to groups of 4-6 patients who exercise at home and communicate via tablet-camera. After 10-weeks of PTR, participants are offered once weekly PTR for 60minuttes in groups of 4-8 patients throughout a 65-week maintenance period (secondary endpoint 75-weeks from baseline).

HPR is an individual self-initiated home-based PR program. Patient goal is to achieve at least 20 min of self-initiated muscle-endurance based exercise 3days/weekly for 10-weeks (primary endpoint). The first session is a home visit by an experienced respiratory physiotherapist and with focus on establishment of exercise goals, formal exercise prescription and education. The home visit is followed by 1/weekly session for 10-weeks.The sessions is delivered from Hvidovre/Bispebjerg Hospital via tablet-camera or telephone call. After 10-weeks of HPR, participants are offered once weekly PTR for 60min in groups of 4-8 patients throughout a 65-week maintenance period (secondary endpoint 75-weeks from baseline).

Control group will receive usual care; medication, scheduled follow-up visit and possible phone contact with GP or the outpatient respiratory department. Except for assessment visits 10-, 35-, and 75-weeks from baseline no intervention is offered.

Outcomes

Primary Outcome Measures

Change in COPD Assessment Test (CAT)
Patient completed questionnaires that assess respiratory symptoms. Eight item questionaire with total score from 0-40 points.

Secondary Outcome Measures

Change in 1-minute sit-to-stand test (1-min-STS)
measures endurance
Change in 30seconds sit-to-stand test (30sec-STS)
measures muscle strength
Change in Short Physcial Performance Battery (SPPB)
Measures frailty/possible sarcopenia/ mobility disaabilities
Change in Handgrip strength (JAMAR)
measures handgrip muscle strength in kilo. High is better
Changes in objectively measured physical acitivity (50% of total sample)
Devise is ActivePAL triaxial accelerometer (PAL Technologies Ltd., Glascow, UK). Wearing time is 24 h per day for 5 days at each time point. Measures sedentary and active body movements, steps per day and METs. High number of activity is better
Change in Hospital Anxiety and Depression Scale (HADS)
Patient completed questionnaires that assess anxiety and depression symptoms. Seven item domain questions for depression with total score form 0-21 point. Seven item domain questions for anxiety with total score fra 0-21 points.
Change in Euro Qol (EQ5D-3L)
Patient completed questionnaires that assess quality of life. Total score fra 0-1 on EQ5D-health domain. Total score from 0-100mm on EQ5D-vas domain. No total domain score
Change Brief Pain Inventory (BPI)
Patient completed questionnaires that assess pain. Low score is better
Change Multidimensional Fatigue Inventory (MFI-20)
Patient completed questionnaires that assess pain. Low score is better
Change Pittsburg Sleep Quality Index (PSQI)
Interview completed questionnaire that assess sleep quality. Low score is better
Program completion
The number of participants who complete their allocated rehabilitation program (attend at least 70% of planned sessions).
Number of hospital admissions (respiratory related and all-cause)
Total number
Mortality (respiratory related and all-cause)
Total number
Adverse events
numbers of SAE and AE

Full Information

First Posted
December 9, 2022
Last Updated
February 7, 2023
Sponsor
Copenhagen University Hospital, Hvidovre
Collaborators
Copenhagen University Hospital Bispebjerg-Frederiksberg, Copenhagen University Hospital, Nordsjaelland, Copenhagen University Hospital, Gentofte-Herlev, Copenhagen University Hospital, Glostrup, Copenhagen University Hospital, Amager
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1. Study Identification

Unique Protocol Identification Number
NCT05664945
Brief Title
Rethinking Pulmonary Rehabilitation
Acronym
REPORT
Official Title
Rethinking Pulmonary Rehabilitation for Patients With COPD: a Three-arm Randomised Multicentre Trial (REPORT-trial)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Copenhagen University Hospital, Hvidovre
Collaborators
Copenhagen University Hospital Bispebjerg-Frederiksberg, Copenhagen University Hospital, Nordsjaelland, Copenhagen University Hospital, Gentofte-Herlev, Copenhagen University Hospital, Glostrup, Copenhagen University Hospital, Amager

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pulmonary rehabilitation (PR) is one of the cornerstones of care for people with COPD together with smoking cessation and medical treatment. Despite the compelling evidence for its benefits, pulmonary rehabilitation is delivered to less than 30% of patients with COPD. Access to PR are particularly challenging, and especially for those with the most progressed stages of the disease. Pulmonary Tele-rehabilitation (PTR) and Home-based pulmonary rehabilitation (HPR) are two emerging models using health-care supportive technology that have proven equivalent to the conventional PR programs in patients with COPD who are able and willing to participate in conventional PR. However, much remain unknown regarding patients with COPD unable to access and participate in the conventional out-patient hospital- or community-based PR when offered during routine consultation. No studies have been conducted to specifically intervene towards this group. Response from emerging rehabilitation models for this specific group is a black box with no substantial research. To fulfill its potential of relevance, results from emerging models, such as Pulmonary Telerehabilitation and Home-based pulmonary rehabilitation must be of clinical relevance, and superior to the current 'usual care' (medication and scheduled follow-up control) in patients with COPD unable to access and participate in the conventional out-patient hospital- or community-based PR when offered during routine consultation.
Detailed Description
This trial will investigate if pulmonary tele-rehabilitation (PTR) and home-based pulmonary rehabilitation (HPR) leads to respiratory symptom relief (CAT score) and improvements on secondary outcomes in patients unable to access conventional rehabilitation programs (standard PR offer). Our hypotheses in a three-arm RCT design are PTR and HPR will be equivalent to each other PTR and HPR will be superior to usual care, that is the control group (CON - no intervention)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized clinical, assessor- and statistician blinded multicentre trial with three parallel-groups
Masking
InvestigatorOutcomes Assessor
Masking Description
Participants will be informed that the trial is assessing the impact of pulmonary rehabilitation models on predetermined outcomes, but not the specific nature of the models of interest, and the predetermined hypothesis of the intervention group allocated to. All assessors are blinded to group allocation and previous test results. In case of failure keeping the outcome assessor blinded (that is, if a participant reveals his/her allocation) a second assessor will be available to step in and conduct the assessment on another day. To avoid investigators (subconscious) bias the biostatistician who perform the data analyses and validate the results is blinded to group allocation. The research group will interpret the results, before the allocation code is broken.
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pulmonary tele-rehabilitation (PTR)
Arm Type
Experimental
Arm Description
Recieve supervised PTR 2/weekly, session duration of 60 min; 35 min of exercise and 25min of patient education for 10-weeks (primary endpoint). Delivered from Hvidovre/Bispebjerg Hospital to groups of 4-6 patients who exercise at home and communicate via tablet-camera. After 10-weeks of PTR, participants are offered once weekly PTR for 60minuttes in groups of 4-8 patients throughout a 65-week maintenance period (secondary endpoint 75-weeks from baseline).
Arm Title
home-based pulmonary rehabilitation (HPR)
Arm Type
Experimental
Arm Description
HPR is an individual self-initiated home-based PR program. Patient goal is to achieve at least 20 min of self-initiated muscle-endurance based exercise 3days/weekly for 10-weeks (primary endpoint). The first session is a home visit by an experienced respiratory physiotherapist and with focus on establishment of exercise goals, formal exercise prescription and education. The home visit is followed by 1/weekly session for 10-weeks.The sessions is delivered from Hvidovre/Bispebjerg Hospital via tablet-camera or telephone call. After 10-weeks of HPR, participants are offered once weekly PTR for 60min in groups of 4-8 patients throughout a 65-week maintenance period (secondary endpoint 75-weeks from baseline).
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control group will receive usual care; medication, scheduled follow-up visit and possible phone contact with GP or the outpatient respiratory department. Except for assessment visits 10-, 35-, and 75-weeks from baseline no intervention is offered.
Intervention Type
Behavioral
Intervention Name(s)
pulmonary tele-rehabilitation (PTR)
Intervention Description
PTR is delivered from promoter hospital to a group of 4-6 patients who exercise at home and communicate via tablet-camera. Each session is 60 min; 35 min exercise/ 25 min patient education, two times per week for a duration of 10-weeks (primary endpoint). Specific exercises are evidence-based; been used in several intervention studies on patients with COPD. Exercises involves larger muscle groups with 50/50 exercises for upper and lower extremities. Volume, intensity and content exercise protocol follow both national and international exercise recommendations. The education sessions consist of dialogue, reflections around empowerment and better living with COPD. Every fourth education session consists of 25 min Mindfulness exercises developed for COPD patients. After 10-weeks of PTR, participants are offered once weekly PTR for 60min in groups of 4-8 persons throughout a 65-week maintenance period (secondary endpoint 75-weeks from baseline).
Intervention Type
Behavioral
Intervention Name(s)
home-based pulmonary rehabilitation (HPR)
Intervention Description
HPR is an individual self-initiated home-based PR aiming to achieve 20 min of self-initiated muscle-endurance based exercise; 3-days/weekly for 10-weeks (primary endpoint). Exercises are evidence-based; used in several intervention studies on patients with COPD and involves larger muscle groups with 50/50 exercises for upper/lower extremities. First session is a home visit by a respiratory physiotherapist. During the visit the physiotherapist and patient establish exercise goals, exercise prescription and provision of mindfulness exercises and educationbook. The home visit is followed by one weekly session for 10-weeks. A menu of topics relevant to COPD and self-management is discussed. A session is delivered from promoter hospital via tablet-camera or telephone call (patients' preference). After 10-weeks of HPR, participants are offered once weekly PTR for 60min in groups of 4-8 persons throughout a 65-week maintenance period (secondary endpoint 75-weeks from baseline).
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Receive usual care; medication, scheduled follow-up visit and possible phone contact with GP and the outpatient respiratory department. Except for assessment visits 10-, 35-, and 75-weeks from baseline no intervention is offered. If a patient changes his/her mind and wishes to participate in a conventional hospital- or community-based PR program, it will be granted as this is a highly recommended treatment (e.g. rehabilitation after hospital admitted exacerbation).
Primary Outcome Measure Information:
Title
Change in COPD Assessment Test (CAT)
Description
Patient completed questionnaires that assess respiratory symptoms. Eight item questionaire with total score from 0-40 points.
Time Frame
Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Secondary Outcome Measure Information:
Title
Change in 1-minute sit-to-stand test (1-min-STS)
Description
measures endurance
Time Frame
Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Title
Change in 30seconds sit-to-stand test (30sec-STS)
Description
measures muscle strength
Time Frame
Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Title
Change in Short Physcial Performance Battery (SPPB)
Description
Measures frailty/possible sarcopenia/ mobility disaabilities
Time Frame
Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Title
Change in Handgrip strength (JAMAR)
Description
measures handgrip muscle strength in kilo. High is better
Time Frame
Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Title
Changes in objectively measured physical acitivity (50% of total sample)
Description
Devise is ActivePAL triaxial accelerometer (PAL Technologies Ltd., Glascow, UK). Wearing time is 24 h per day for 5 days at each time point. Measures sedentary and active body movements, steps per day and METs. High number of activity is better
Time Frame
Baseline; 10-weeks from baseline ( primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Title
Change in Hospital Anxiety and Depression Scale (HADS)
Description
Patient completed questionnaires that assess anxiety and depression symptoms. Seven item domain questions for depression with total score form 0-21 point. Seven item domain questions for anxiety with total score fra 0-21 points.
Time Frame
Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Title
Change in Euro Qol (EQ5D-3L)
Description
Patient completed questionnaires that assess quality of life. Total score fra 0-1 on EQ5D-health domain. Total score from 0-100mm on EQ5D-vas domain. No total domain score
Time Frame
Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Title
Change Brief Pain Inventory (BPI)
Description
Patient completed questionnaires that assess pain. Low score is better
Time Frame
Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Title
Change Multidimensional Fatigue Inventory (MFI-20)
Description
Patient completed questionnaires that assess pain. Low score is better
Time Frame
Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Title
Change Pittsburg Sleep Quality Index (PSQI)
Description
Interview completed questionnaire that assess sleep quality. Low score is better
Time Frame
Baseline; 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Title
Program completion
Description
The number of participants who complete their allocated rehabilitation program (attend at least 70% of planned sessions).
Time Frame
at 10-weeks from baseline (primary endpoint); 75-weeks from baseline (secondary endpoint)
Title
Number of hospital admissions (respiratory related and all-cause)
Description
Total number
Time Frame
at 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Title
Mortality (respiratory related and all-cause)
Description
Total number
Time Frame
at 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)
Title
Adverse events
Description
numbers of SAE and AE
Time Frame
at 10-weeks from baseline (primary endpoint); 35-weeks from baseline; 75-weeks from baseline (secondary endpoint)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Indication for pulmonary rehabilitation according to Danish national guidelines Unable to access and participate in the conventional out-patient hospital- or community-based PR when offered during routine consultation A post-bronchodilator ratio FEV1/FVC <70% (confirmed physician diagnosis of COPD) A post-bronchodilator FEV1 <80% (degree of airway obstruction) corresponding to GOLD grade 2-4 (moderate to very severe) GOLD group B, C, D corresponding to severe respiratory symptoms and/or frequent acute exacerbations Able to stand up from a chair (height 44-46cm) and walk 10 meters independently (with or without a walking aid) Able to lift both arms to a horizontal level with a minimum of 1 kilogram's dumbbells in each hand Exclusion Criteria: Participation in conventional PR in the past 24 months Cognitive impairment - unable to follow instructions Impaired hearing or vision - unable to see or hear instruction from a tablet Unable to understand and speak Danish Comorbidities where the exercise content is contraindicated (e.g. treatment for diabetic foot ulcer, active cancer treatment, life expectancy <12-months)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henrik Hansen, PhD
Phone
+4528946780
Email
henrik.hansen.09@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Nielsen, PT, Msc
Phone
+4520952588
Email
christina.nielsen.07@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Hansen, PhD
Organizational Affiliation
Dept. of Respiratory Medicine, University Hospital Hvidovre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nina Godtfredsen, MD, PhD
Organizational Affiliation
Dept. of Respiratory Medicine, University Hospital Hvidovre
Official's Role
Study Chair
Facility Information:
Facility Name
Copenhagen University Hospital Amager
City
Copenhagen
State/Province
Greater Copenhagen
ZIP/Postal Code
2300
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nina Godtfredsen, PhD, MD
Phone
+4525466402
Email
nina.skavlan.godtfredsen@regionh.dk
Facility Name
Copenhagen University Hospital Bispebjerg-Frederiksberg
City
Copenhagen
State/Province
Greater Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anette Agerholm, RN
Phone
+45 40172422
Email
anette.agerholm.01@regionh.dk
First Name & Middle Initial & Last Name & Degree
Hanne Dybdal Ehlers, RN
Phone
+45 23281380
Email
hanne.dybdal.ehlers@regionh.dk
Facility Name
Copenhagen University Hospital Herlve-Gentofte
City
Gentofte
State/Province
Greater Copenhagen
ZIP/Postal Code
2820
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jakob Lyngby Kjærgaard, PhD, MD
Phone
+45 38674211
Email
jakob.lyngby.kjaergaard@regionh.dk
First Name & Middle Initial & Last Name & Degree
Togny Wilcke, PhD, MD
Phone
+45 61635609
Email
jon.torgny.wilcke@regionh.dk
Facility Name
Copenhagen University Hospital Glostrup
City
Glostrup
State/Province
Greater Copenhagen
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janne Sørensen, RN
Phone
+45 38633609
Email
janne.soerensen@regionh.dk
Facility Name
Copenhagen University Hospital Nordsjaelland
City
Hillerød
State/Province
Greater Copenhagen
ZIP/Postal Code
3400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stig Mølsted, PhD
Phone
+45 31959849
Email
stig.moelsted@regionh.dk
First Name & Middle Initial & Last Name & Degree
Sonja Ishøj, RN
Phone
+45 48292950
Email
sonja.ishoei@regionh.dk
Facility Name
Copenhagen University Hospital Hvidovre
City
Hvidovre
State/Province
Greater Copenhagen
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Hansen, PhD
Phone
+4528946780
Email
henrik.hansen.09@regionh.dk
First Name & Middle Initial & Last Name & Degree
Nina Godtfredsen, PhD, MD
Phone
+4525466402
Email
nina.skavlan.godtfredsen@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Access demands a part application to; (1) Danish Data Protection agency, (2) ethics committee of the capital region, (3) national health Data authorities. Only if the applications are approved data will be considered available for sharing. The investigator will not be able to support this process.

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Rethinking Pulmonary Rehabilitation

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