Clinical trial NCT04599387: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Rehabilitation
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: BIOGRADIENT LTD
First posted: 2020-10-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in 6 Minute walk test (6MWT)
timeFrame: between baseline and 48weeks (end of trial)
Secondary outcomes:
measure: Change in mean oxygen saturation
timeFrame: between baseline and 48weeks (end of trial)
measure: Change in minimal oxygen saturation
timeFrame: between baseline and 48weeks (end of trial)
measure: change in BORG scale
timeFrame: between baseline and 48weeks (end of trial)
measure: change in average number of steps during 6MWT
timeFrame: between baseline and 48weeks (end of trial)
measure: change in Modified Medical Research Council (MMRC) dyspnea scale
timeFrame: between baseline and 48weeks (end of trial)
measure: change in COPD Assessment Test (CAT) scale
timeFrame: between baseline and 48weeks (end of trial)
measure: change in St. George Respiratory Questionnaire (SGRQ)
timeFrame: between baseline and 48weeks (end of trial)
measure: Number of severe COPD exacerbation
timeFrame: through study completion, an average of 1 year
measure: Number of moderate COPD exacerbations
timeFrame: through study completion, an average of 1 year
measure: change in FEV1/FVC
timeFrame: between baseline and 48weeks (end of trial)
measure: change in FVC (forced vital capacity)
timeFrame: between baseline and 48weeks (end of trial)
measure: change in FEV1 (forced expiratory volume in one minute)
timeFrame: between baseline and 48weeks (end of trial)
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References: