Pilot Study of a Home-based Exercise Intervention to Treat Frailty in Lung Transplant Candidates
Phase: NA
Conditions: Advanced Lung Disease
Sponsor: University of California, San Francisco

UCSF CHR 15-17503 
Prehab Study Protocol 
 
 
 
 
Prehab Study 
 
A pilot study of a home-based 
intervention to treat frailty in lung 
transplant candidates 
 
 
Study Protocol 
Date of document: 10/13/16 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

UCSF CHR 15-17503 
Prehab Study Protocol 
 
Potential subjects will be selected from existing enrollment in Dr. Jonathan Singer's ongoing 
Frailty study (UCSF CHR: Frailty 12-08437) or in the Global UCSF Study (UCSF CHR: Global 
13-10738). 
In-Person Assessment and Training: 
1. Explain the goal of the program: to treat frailty in order to optimize physical functioning 
status before lung transplantation 
2. Frailty assessment if not already performed within the previous 14 days. Frailty will be 
assessed with the Short Physical Performance Battery (SPPB).  The SPBB is a well-
validated battery of 3 lower extremity performance measures: walking speed, chair 
stands, and balance. Measures are scored from 0-4 and integrated into a summary score 
ranging from 0-12. The battery has excellent inter-observer reliability, test-retest 
reliability, and predictive validity.  
o Balance: test whether subjects can stand on their own without assistive devices 
with their feed in tandem for 10 seconds, staggered for 10 seconds, and one 
directly in front of the other for 10 seconds.        
o Chair stands: time (in seconds) required to stand up and sit down from a chair five 
times. 
o Walk speed: time (in seconds) required to walk 4.57 meters at subject's usual 
pace. 
3. Determine exercise capacity according to ATS Guidelines 
(https://www.thoracic.org/statements/resources/pfet/cardioexercise.pdf):  
o Six Minute Walk Test (6MWT) if not performed in the previous 14 days 
o Perform and teach oxygen titration with exercise/activity. 
4. Determine nutritional status:  
o Meet with a clinical dietician to review dietary habits 
o Measure height and weight to calculate body mass index and ideal body weight 
5. Develop prescription for exercise: frequency, duration, modes, intensity, plans for 
progression based on American Thoracic Society Guidelines. Exercise prescription will 
be developed by Chris Garvey, NP, who develops treatment plans and exercise 
prescriptions at the UCSF Pulmonary Rehabilitation Program and previously did the 
same at the Seton Hospital Pulmonary and Cardiac Rehabilitaiton Program for 20 years.   
o Aerobic: walking or exercise bike or treadmill based on available equipment at 
home 
o Strength training:  
 
Arms: with latex-free elastic bands and push-ups against a wall 
 
Legs: repeated chair stands, extension with latex-free elastic bands  
 
Based on the Weight-Bearing and Better Balance Protocols 
o Strategies for improving balance 
o Teach and model teach-back of exercises 
o Distribution of tablets with Aidcube app preloaded and training on how to use the 
program at home - each subject's exercise plan will be programmed by Chris 
Garvey through the "provider portal"  
 
Exercise plans are customizable: different plans can be developed for days 
of the week, times of the day, and frequencies 

UCSF CHR 15-17503 
Prehab Study Protocol 
 
 
Exercise plans will be advanced over time: the provider sees the 
participant activity through the provider portal and can adjust the exercise 
plans in real time, allowing for “exercise progression”. 
 
The patient portal provides the exercise prescription to the patient and 
direct feedback allowing them to track progress and interact with their 
provider through a messaging interface 
 
Notably, the Aidcube app is commercially available and approved and 
reimbursed by insurers in the Netherlands for home pulmonary 
rehabilitation in patients with COPD.  
6. Develop a diet plan based on estimated caloric needs, food habits, and body mass index  
o For supplements, will recommend commercially available, high energy, high 
protein supplements 
7. Self-management skills: control of dyspnea, fatigue, motivation, and support 
8. Training in protocol implementation at home by coordinator trained in principles of 
behavior change, adult learning theory, and dyspnea control techniques 
Subjects will be compensated $30 to cover the cost of parking when coming in for the in-person 
assessment. 
Home Program: 
The frequency, intensity, and progression of the individually tailored three-month exercise 
program will be based upon results acquired through Aidcube. However, the program will target 
no less than 30 minutes of combined aerobic and strength training exercises three times a week. 
Method of monitoring 
 
Aidcube app 
 
Fitbit activity tracker 
 
A study coordinator will call subjects weekly in addition to interacting with participants 
through the app interface. 
Adherence 
 
Weekly phone calls for encouragement 
 
Checking Fitbit activity data 
In person follow up after the 8 week intervention: 
Participants will return 8 weeks after their in-person assessment and will repeat the SPPB and 
6MWT with the study coordinator.