Remote Prescribed and Monitored Exercise Program After Pulmonary Rehabilitation in Individuals With Chronic Lung Disease

October 17, 2020 updated by: Sheba Medical Center
Remote Prescribed and Monitored Exercise Program After Pulmonary Rehabilitation in Individuals with Chronic Lung Disease

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

To be eligible for enrollment, participants must have the following inclusion criteria:

  1. Age>18 years old
  2. Diagnosis of COPD, based of FEV1/FVC<0.7
  3. FEV1 % predicted >30%
  4. Participated in PR for at least 18 sessions in the preceding year.
  5. Capable of providing signed written informed consent

Exclusion Criteria:

  • Participants are excluded if they have at least one of the following criteria:

    1. Currently attend (more than 5 future sessions) or eligible for a PR program
    2. On long term oxygen therapy (LTOT)
    3. Participation in another clinical study that may have an impact on the primary outcome of the current study
    4. Deemed by the healthcare team to be physically incapable of participating in the study
    5. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Supervised Exercise arm
Other: Remote Exercise Prescription
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.
PLACEBO_COMPARATOR: Usual care arm
Other: Usual Care
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in 6 Minute walk test (6MWT)
Time Frame: between baseline and 48weeks (end of trial)
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.
between baseline and 48weeks (end of trial)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in mean oxygen saturation
Time Frame: between baseline and 48weeks (end of trial)
during 6MWT
between baseline and 48weeks (end of trial)
Change in minimal oxygen saturation
Time Frame: between baseline and 48weeks (end of trial)
During 6MWT
between baseline and 48weeks (end of trial)
change in BORG scale
Time Frame: between baseline and 48weeks (end of trial)
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
between baseline and 48weeks (end of trial)
change in average number of steps during 6MWT
Time Frame: between baseline and 48weeks (end of trial)
An average of the number of steps done per day in the preceding week before the 6MWT.
between baseline and 48weeks (end of trial)
change in Modified Medical Research Council (MMRC) dyspnea scale
Time Frame: between baseline and 48weeks (end of trial)
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
between baseline and 48weeks (end of trial)
change in COPD Assessment Test (CAT) scale
Time Frame: between baseline and 48weeks (end of trial)
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.
between baseline and 48weeks (end of trial)
change in St. George Respiratory Questionnaire (SGRQ)
Time Frame: between baseline and 48weeks (end of trial)
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.
between baseline and 48weeks (end of trial)
Number of severe COPD exacerbation
Time Frame: through study completion, an average of 1 year
Defined as any exacerbation that led to hospitalization and/or emergency department (ED) visit.
through study completion, an average of 1 year
Number of moderate COPD exacerbations
Time Frame: through study completion, an average of 1 year
Defined as any exacerbation treated with parenteral corticosteroids with or without antibiotics
through study completion, an average of 1 year
change in FEV1/FVC
Time Frame: between baseline and 48weeks (end of trial)
Will be collected during the recruitment and concluding session, and once every 6 months.
between baseline and 48weeks (end of trial)
change in FVC (forced vital capacity)
Time Frame: between baseline and 48weeks (end of trial)
Will be collected during the recruitment and concluding session, and once every 6 months.
between baseline and 48weeks (end of trial)
change in FEV1 (forced expiratory volume in one minute)
Time Frame: between baseline and 48weeks (end of trial)
Will be collected during the recruitment and concluding session, and once every 6 months.
between baseline and 48weeks (end of trial)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheba Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
BIOGRADIENT LTD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHEBA-20-7416-DO-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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