NCT04599387

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Disease, Chronic Obstructive
• Rehabilitation

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2020-11-01
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2020-10-22
• Last updated: 2020-10-22

Locations

1 site across 1 country: Israel