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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04599387
• Other study ID #: SHEBA-20-7416-DO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: October 2020
• Source: Sheba Medical Center
• Contact: David Ovadya, Dr.
• Phone: 972507673634
• Email: david.ovadya[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive
• Rehabilitation

Intervention

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.
• 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

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	BIOGRADIENT LTD

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in mean oxygen saturation	during 6MWT	between baseline and 48weeks (end of trial)
Secondary	Change in minimal oxygen saturation	During 6MWT	between baseline and 48weeks (end of trial)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)