Adaptive Home Based Pulmonary Tele-exercise

NCT04575220 | Completed

• 1 other identifier: 58756
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot study is to determine if a home based bicycle exercise program can significantly improve the exercise tolerance and well being of pulmonary outpatients. The investigators will use a computer based monitoring system to allow us to speak with participants, view participants, and track patient bicycle activity (speed, duration of exercise, rate of work) during exercise sessions. The investigators plan to have participants perform three telemonitored exercise sessions per week for 12 weeks as part of this program. The investigators will assess exercise performance on the bicycle, called a work rate test, at the beginning of the program and then again at 6 weeks and 12 weeks into the program to determine if the program can produce a clinically significant improvement in work rate test performance (i.e. a greater than 1.15 minute increase in exercise duration at an 80% work rate). The investigators will also assess participant CRQ, SPPB scores and SF36 scores (indices of patient well being) at baseline, at 6 weeks, and at 12 weeks, to determine if the exercise program elicits an increase in these indices.

Conditions

Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 80% work rate test

  This will measure changes in the time the subject can exercise at 80% of the maximum work rate.

  This will be measured at baseline, at 6 weeks, and at 12 weeks. The primary outcome measure to be assessed is the change in the 80% work rate test time between the initial and 12 week assessment.

Secondary Outcomes (3)

• CRQ score: Chronic Respiratory Questionnaire

  baseline and at 6 weeks and 12 weeks

• SF36: Short Form Survey; 36 Questions

  baseline and at 6 weeks and 12 weeks

• SPPB: Short Physical Performance Battery

  baseline and at 6 weeks and 12 weeks

Study Arms (1)

tele-exercise

EXPERIMENTAL

Subjects will perform three sessions/week of home exercise using bicycles for 12 weeks

Other: 12 weeks of bicycle exercise

Interventions

12 weeks of bicycle exercise OTHER

Subjects will conduct monitored exercise, three sessions per week for 12 weeks.

tele-exercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age from 18-80 years
• previous diagnosis of pulmonary disease, including known chronic pulmonary diseases (COPD, ILD), recent admission for pulmonary disease (pneumonia, asthma, obstructive lung disease), recent ICU discharge for a diagnosis of respiratory failure, and/or previous COVID-19 disease with demonstration of recovery (two negative antigen tests)
• the capacity to perform cycling exercise

You may not qualify if:

• if the physician caring for the patient determines that the patient should not participate in a home based exercise program
• if the patient has active ischemic cardiac disease
• if the patient's home does not have sufficient space or internet connectivity for the computer and bicycle to be operative
• if the patient is a pregnant female
• if the patient is a prisoner
• if the patient is institutionalized
• if the patient has a terminal clinical condition.

Sponsors & Collaborators

• Leigh Ann Callahan, MD: lead

Study Sites (1)

Chandler Hospital

Lexington, Kentucky, 40536, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Single arm pilot study evaluating fitness before and after home based rehabilitation

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: October 5, 2020
• Study Start: October 20, 2020
• Primary Completion: March 2, 2022
• Study Completion: March 2, 2022
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)