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

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

Study Overview

• Status: Unknown
• Conditions: Pulmonary Disease, Chronic Obstructive; Rehabilitation
• Intervention / Treatment: Other: Remote Exercise Prescription; Other: Usual Care

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: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel
    • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	between baseline and 48weeks (end of trial)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean oxygen saturation	during 6MWT	between baseline and 48weeks (end of trial)
Change in minimal oxygen saturation	During 6MWT	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	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.	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	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.	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.	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.	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	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.	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.	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.	between baseline and 48weeks (end of trial)

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Collaborators: BIOGRADIENT LTD

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2020
• Primary Completion (ANTICIPATED): November 1, 2022
• Study Completion (ANTICIPATED): November 1, 2022

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 17, 2020
• First Posted (ACTUAL): October 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 17, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID 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