Pulmonary Disease, Chronic ObstructiveNCT04599387
Remote Prescribed and Monitored Exercise Program After Pulmonary Rehabilitation in Individuals With Chronic Lung Disease
A study testing Remote Exercise Prescription in people with Pulmonary Disease, Chronic Obstructive and Rehabilitation, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Remote Prescribed and Monitored Exercise Program After Pulmonary Rehabilitation in Individuals with Chronic Lung Disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Rehabilitation
- What is being tested?
- Remote Exercise Prescription
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2020to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Remote Prescribed and Monitored Exercise Program After Pulmonary Rehabilitation in Individuals with Chronic Lung Disease
Read the 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.
- Being tested
- Remote Exercise Prescription, Usual Care
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Exercise PrescriptionOther
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.
Usual CareOther
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
| Study group | Role | What they receive |
|---|---|---|
| Supervised Exercise arm | Active comparator | Not described Receives: Other: Remote Exercise Prescription |
| Usual care arm | Placebo comparator | Not described Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: between baseline and 48weeks (end of trial)
Secondary outcomes (12)
Change in mean oxygen saturation
during 6MWT
Measured: between baseline and 48weeks (end of trial)
Change in minimal oxygen saturation
During 6MWT
Measured: between baseline and 48weeks (end of trial)
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
Measured: between baseline and 48weeks (end of trial)
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.
Measured: between baseline and 48weeks (end of trial)
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
Measured: between baseline and 48weeks (end of trial)
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.
Measured: between baseline and 48weeks (end of trial)
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.
Measured: between baseline and 48weeks (end of trial)
Number of severe COPD exacerbation
Defined as any exacerbation that led to hospitalization and/or emergency department (ED) visit.
Measured: through study completion, an average of 1 year
Number of moderate COPD exacerbations
Defined as any exacerbation treated with parenteral corticosteroids with or without antibiotics
Measured: through study completion, an average of 1 year
change in FEV1/FVC
Will be collected during the recruitment and concluding session, and once every 6 months.
Measured: between baseline and 48weeks (end of trial)
change in FVC (forced vital capacity)
Will be collected during the recruitment and concluding session, and once every 6 months.
Measured: between baseline and 48weeks (end of trial)
change in FEV1 (forced expiratory volume in one minute)
Will be collected during the recruitment and concluding session, and once every 6 months.
Measured: between baseline and 48weeks (end of trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- BIOGRADIENT LTD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599387
- Sponsor's protocol ID
- SHEBA-20-7416-DO-CTIL
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Prescribed and Monitored Exercise Program After Pulmonary Rehabilitation in Individuals With Chronic Lung Disease
- ClinicalTrials.gov ID
- NCT04599387
- Acronym / sponsor ID
- SHEBA-20-7416-DO-CTIL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- BIOGRADIENT LTD
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised Exercise arm | Active comparator | Other: Remote Exercise Prescription |
| Usual care arm | Placebo comparator | Other: Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Participants are excluded if they have at least one of the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Exercise PrescriptionExercise 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. | Other | Supervised Exercise arm |
| Usual CareExercise 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 | Other | Usual care arm |
Primary outcome
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.
12 secondary outcomes
Change in mean oxygen saturation
Time frame: between baseline and 48weeks (end of trial)
Change in minimal oxygen saturation
Time frame: between baseline and 48weeks (end of trial)
change in BORG scale
Time frame: between baseline and 48weeks (end of trial)
change in average number of steps during 6MWT
Time frame: 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)
change in COPD Assessment Test (CAT) scale
Time frame: between baseline and 48weeks (end of trial)
change in St. George Respiratory Questionnaire (SGRQ)
Time frame: between baseline and 48weeks (end of trial)
Number of severe COPD exacerbation
Time frame: through study completion, an average of 1 year
Number of moderate COPD exacerbations
Time frame: through study completion, an average of 1 year
change in FEV1/FVC
Time frame: between baseline and 48weeks (end of trial)
change in FVC (forced vital capacity)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Exercise Prescription in people with Pulmonary Disease, Chronic Obstructive and Rehabilitation, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Ovadya, Dr. (972507673634, david.ovadya@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6 Minute walk test (6MWT) (time frame: between baseline and 48weeks (end of trial)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.