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

Not Applicable

• Conditions: Rehabilitation; Pulmonary Disease, Chronic Obstructive
• Interventions: Other: Remote Exercise Prescription; Other: Usual Care

• Registration Number: NCT04599387
• Lead Sponsor: Sheba Medical Center

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.

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-17
• Last Update Submitted: 2020-10-17
• Study First Posted: 2020-10-22
• Last Update Posted: 2020-10-22
• Study Start: 2020-11-01
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised Exercise arm	Remote Exercise Prescription	-
Usual care arm	Usual Care	-

Primary Outcome Measures

Name	Time	Method
Change in 6 Minute walk test (6MWT)	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.

Secondary Outcome Measures

Name	Time	Method
Change in mean oxygen saturation	between baseline and 48weeks (end of trial)	during 6MWT
Change in minimal oxygen saturation	between baseline and 48weeks (end of trial)	During 6MWT
change in BORG scale	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
change in average number of steps during 6MWT	between baseline and 48weeks (end of trial)	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	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
change in COPD Assessment Test (CAT) scale	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.
change in St. George Respiratory Questionnaire (SGRQ)	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.
Number of severe COPD exacerbation	through study completion, an average of 1 year	Defined as any exacerbation that led to hospitalization and/or emergency department (ED) visit.
Number of moderate COPD exacerbations	through study completion, an average of 1 year	Defined as any exacerbation treated with parenteral corticosteroids with or without antibiotics
change in FEV1/FVC	between baseline and 48weeks (end of trial)	Will be collected during the recruitment and concluding session, and once every 6 months.
change in FVC (forced vital capacity)	between baseline and 48weeks (end of trial)	Will be collected during the recruitment and concluding session, and once every 6 months.
change in FEV1 (forced expiratory volume in one minute)	between baseline and 48weeks (end of trial)	Will be collected during the recruitment and concluding session, and once every 6 months.

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel