Remote Prescribed and Monitored Exercise Program After Pulmonary Rehabilitation in Individuals With Chronic Lung Disease
Primary Purpose
Pulmonary Disease, Chronic Obstructive, Rehabilitation
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Remote Exercise Prescription
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion Criteria:
To be eligible for enrollment, participants must have the following inclusion criteria:
- Age>18 years old
- Diagnosis of COPD, based of FEV1/FVC<0.7
- FEV1 % predicted >30%
- Participated in PR for at least 18 sessions in the preceding year.
- Capable of providing signed written informed consent
Exclusion Criteria:
Participants are excluded if they have at least one of the following criteria:
- Currently attend (more than 5 future sessions) or eligible for a PR program
- On long term oxygen therapy (LTOT)
- Participation in another clinical study that may have an impact on the primary outcome of the current study
- Deemed by the healthcare team to be physically incapable of participating in the study
- Presence of comorbidities which, in the opinion of the healthcare team, might prevent patients from safely undertaking an exercise programme at home (for example severe orthopaedic or neurological impairments, severe cognitive impairment)
Sites / Locations
- Sheba Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Supervised Exercise arm
Usual care arm
Arm Description
Outcomes
Primary Outcome Measures
Change in 6 Minute walk test (6MWT)
For this measurement the patient will be asked to performed a maximal effort for 6 minutes for which the distance walked (in meters) will be determined. To note that a self-administered 6MWT was found to yield repeatable and accurate measurement as compared to clinic administered 6MWT.
Secondary Outcome Measures
Change in mean oxygen saturation
during 6MWT
Change in minimal oxygen saturation
During 6MWT
change in BORG scale
BORG rating of perceived exertion (RPE) at the end of the 6MWT (will be reported by a smart phone application). grade from 0 to 10, with higher numbers indicate higher perceived exertion
change in average number of steps during 6MWT
An average of the number of steps done per day in the preceding week before the 6MWT.
change in Modified Medical Research Council (MMRC) dyspnea scale
self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4, with higher scores indicating higher breathlessness
change in COPD Assessment Test (CAT) scale
measure the impact of COPD on a person's life. CAT has a scoring range of zero to 40 with higher scores indicating higher impact on person's life.
change in St. George Respiratory Questionnaire (SGRQ)
Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
Number of severe COPD exacerbation
Defined as any exacerbation that led to hospitalization and/or emergency department (ED) visit.
Number of moderate COPD exacerbations
Defined as any exacerbation treated with parenteral corticosteroids with or without antibiotics
change in FEV1/FVC
Will be collected during the recruitment and concluding session, and once every 6 months.
change in FVC (forced vital capacity)
Will be collected during the recruitment and concluding session, and once every 6 months.
change in FEV1 (forced expiratory volume in one minute)
Will be collected during the recruitment and concluding session, and once every 6 months.
Full Information
NCT ID
NCT04599387
First Posted
October 8, 2020
Last Updated
October 17, 2020
Sponsor
Sheba Medical Center
Collaborators
BIOGRADIENT LTD
1. Study Identification
Unique Protocol Identification Number
NCT04599387
Brief Title
Remote Prescribed and Monitored Exercise Program After Pulmonary Rehabilitation in Individuals With Chronic Lung Disease
Official Title
Remote Prescribed and Monitored Exercise Program After Pulmonary Rehabilitation in Individuals With Chronic Lung Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Anticipated)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
Collaborators
BIOGRADIENT LTD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Remote Prescribed and Monitored Exercise Program After Pulmonary Rehabilitation in Individuals with Chronic Lung Disease
Detailed Description
The benefits of exercise during post PR (Pulmonary Rehabilitation) programs in COPD (Chronic Obstructive Pulmonary Disease) patients is well established. However, there are numerous patient's and program factors that influence the benefits gained (e.g. exercise intensity and frequency, goal setting, non-exercise modalities, compliance, social support and supervision). The investigators aim to explore the possibility of a real-life program that will allow the patient the freedom to perform exercise in their own environment. The BioGradient system allows both goal oriented, supervised exercise prescription, and the ability to adapt to the patient's schedule and preferences. The system also provides as needed human involvement for encouragement and supervision.
The investigators hypothesize that the primary outcome (the six-minute walk test, see Outcomes section) will not change significantly in active participants and measures of quality of life and adherence will be higher than reported in the literature in similar publications. Moreover, data collected may provide opportunity to explore the factors that might influence the primary and secondary outcomes, and in particular hospitalizations and exacerbations.
The current study is a patient blinded, randomized control trial, comparing usual care to goal oriented supervised post PR program. After recruitment the patient will be randomized to usual care arm or supervised exercise arm. The study duration will be 1 year (per participant), and the minimal time for each participant to be included in the final analysis will be 3 months (with at least two outcome measurements). At the end of the study each patient will be scheduled a short interview with the research coordinator for assessment of outcome measurements and spirometry testing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supervised Exercise arm
Arm Type
Active Comparator
Arm Title
Usual care arm
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Remote Exercise Prescription
Intervention Description
Exercise sessions will follow the recruitment meeting as prescribed by the BioGradient system, and will be tailored to the patient progress and limitations. In the beginning of each exercise session safety criteria will be collected and will allow participation . In addition, every 8 weeks and during the first exercise session outcome measurements will be collected . The study coordinator will initiate a phone call every 8 weeks to collect session data and discuss progress and limitation with the participant.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Exercise sessions will be initiated by the patient only. In the beginning of each exercise session safety criteria will be collected and will allow participation . Every 8 weeks and once after recruitment outcome measurements will be collected . The study coordinator will initiate a phone call every 8 weeks to collect outcome session data
Primary Outcome Measure Information:
Title
Change in 6 Minute walk test (6MWT)
Description
For this measurement the patient will be asked to performed a maximal effort for 6 minutes for which the distance walked (in meters) will be determined. To note that a self-administered 6MWT was found to yield repeatable and accurate measurement as compared to clinic administered 6MWT.
Time Frame
between baseline and 48weeks (end of trial)
Secondary Outcome Measure Information:
Title
Change in mean oxygen saturation
Description
during 6MWT
Time Frame
between baseline and 48weeks (end of trial)
Title
Change in minimal oxygen saturation
Description
During 6MWT
Time Frame
between baseline and 48weeks (end of trial)
Title
change in BORG scale
Description
BORG rating of perceived exertion (RPE) at the end of the 6MWT (will be reported by a smart phone application). grade from 0 to 10, with higher numbers indicate higher perceived exertion
Time Frame
between baseline and 48weeks (end of trial)
Title
change in average number of steps during 6MWT
Description
An average of the number of steps done per day in the preceding week before the 6MWT.
Time Frame
between baseline and 48weeks (end of trial)
Title
change in Modified Medical Research Council (MMRC) dyspnea scale
Description
self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4, with higher scores indicating higher breathlessness
Time Frame
between baseline and 48weeks (end of trial)
Title
change in COPD Assessment Test (CAT) scale
Description
measure the impact of COPD on a person's life. CAT has a scoring range of zero to 40 with higher scores indicating higher impact on person's life.
Time Frame
between baseline and 48weeks (end of trial)
Title
change in St. George Respiratory Questionnaire (SGRQ)
Description
Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
Time Frame
between baseline and 48weeks (end of trial)
Title
Number of severe COPD exacerbation
Description
Defined as any exacerbation that led to hospitalization and/or emergency department (ED) visit.
Time Frame
through study completion, an average of 1 year
Title
Number of moderate COPD exacerbations
Description
Defined as any exacerbation treated with parenteral corticosteroids with or without antibiotics
Time Frame
through study completion, an average of 1 year
Title
change in FEV1/FVC
Description
Will be collected during the recruitment and concluding session, and once every 6 months.
Time Frame
between baseline and 48weeks (end of trial)
Title
change in FVC (forced vital capacity)
Description
Will be collected during the recruitment and concluding session, and once every 6 months.
Time Frame
between baseline and 48weeks (end of trial)
Title
change in FEV1 (forced expiratory volume in one minute)
Description
Will be collected during the recruitment and concluding session, and once every 6 months.
Time Frame
between baseline and 48weeks (end of trial)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
To be eligible for enrollment, participants must have the following inclusion criteria:
Age>18 years old
Diagnosis of COPD, based of FEV1/FVC<0.7
FEV1 % predicted >30%
Participated in PR for at least 18 sessions in the preceding year.
Capable of providing signed written informed consent
Exclusion Criteria:
Participants are excluded if they have at least one of the following criteria:
Currently attend (more than 5 future sessions) or eligible for a PR program
On long term oxygen therapy (LTOT)
Participation in another clinical study that may have an impact on the primary outcome of the current study
Deemed by the healthcare team to be physically incapable of participating in the study
Presence of comorbidities which, in the opinion of the healthcare team, might prevent patients from safely undertaking an exercise programme at home (for example severe orthopaedic or neurological impairments, severe cognitive impairment)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Ovadya, Dr.
Phone
972507673634
Email
david.ovadya@sheba.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Ronen Rheuveny, PhD
Phone
972549849058
Email
ronen.rheuveny@sheba.health.gov.il
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Remote Prescribed and Monitored Exercise Program After Pulmonary Rehabilitation in Individuals With Chronic Lung Disease
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