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

NCT04599387 | Unknown DMC

• 1 other identifier: SHEBA-20-7416-DO-CTIL
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Disease, Chronic Obstructive; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change in mean oxygen saturation

  between baseline and 48weeks (end of trial)

• Change in minimal oxygen saturation

  between baseline and 48weeks (end of trial)

• change in BORG scale

  between baseline and 48weeks (end of trial)

• change in average number of steps during 6MWT

  between baseline and 48weeks (end of trial)

• change in Modified Medical Research Council (MMRC) dyspnea scale

  between baseline and 48weeks (end of trial)

Study Arms (2)

Supervised Exercise arm

ACTIVE COMPARATOR

Other: Remote Exercise Prescription

Usual care arm

PLACEBO COMPARATOR

Other: Usual Care

Interventions

Remote Exercise Prescription OTHER

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.

Supervised Exercise arm

Usual Care OTHER

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

Usual care arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sheba Medical Center: lead
• BIOGRADIENT LTD: collaborator

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

David Ovadya, Dr.

CONTACT

972507673634; david.ovadya@sheba.health.gov.il

Ronen Rheuveny, PhD

CONTACT

972549849058; ronen.rheuveny@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 22, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)