Trial Outcomes & Findings for Lung Transplant G0 (LTGO): Improving Self-Management of Exercise After Lung Transplantation (NCT NCT03728257)

Last Updated: 2024-10-21

Results Overview

Walking was measured as the change in average steps per day calculated by FitBit worn for periods at baseline and 3 months. Minimum = 0, no upper limit. Higher scores mean a better outcome. Change = (3 month score minus baseline score).

Recruitment status

COMPLETED

Study phase

Target enrollment

88 participants

Primary outcome timeframe

Baseline and 3 months

Results posted on

2024-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	LTGO-Home Based Exercise The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation. LTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement	Enhanced Usual Care Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device. Enhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.
Overall Study STARTED	44	44
Overall Study COMPLETED	41	44
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	LTGO-Home Based Exercise The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation. LTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement	Enhanced Usual Care Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device. Enhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.
Overall Study Death	3	0

Baseline Characteristics

Lung Transplant G0 (LTGO): Improving Self-Management of Exercise After Lung Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LTGO-Home Based Exercise n=44 Participants The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation. LTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement	Enhanced Usual Care n=44 Participants Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device. Enhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.	Total n=88 Participants Total of all reporting groups
Age, Continuous	54.89 years STANDARD_DEVIATION 14.01 • n=5 Participants	57.93 years STANDARD_DEVIATION 11.79 • n=7 Participants	56.41 years STANDARD_DEVIATION 12.96 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	25 Participants n=7 Participants	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants	42 Participants n=7 Participants	84 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	42 Participants n=7 Participants	78 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Average steps per day	3169.62 Average steps per day STANDARD_DEVIATION 2841.43 • n=5 Participants	3507.14 Average steps per day STANDARD_DEVIATION 2535.84 • n=7 Participants	3338.16 Average steps per day STANDARD_DEVIATION 2682.20 • n=5 Participants
Berg Balance	53.69 units on a scale STANDARD_DEVIATION 2.76 • n=5 Participants	52.71 units on a scale STANDARD_DEVIATION 4.30 • n=7 Participants	53.21 units on a scale STANDARD_DEVIATION 3.62 • n=5 Participants
Lower body strength	9.64 Repetitions STANDARD_DEVIATION 2.89 • n=5 Participants	9.78 Repetitions STANDARD_DEVIATION 3.57 • n=7 Participants	9.70 Repetitions STANDARD_DEVIATION 3.21 • n=5 Participants
Respiratory-related quality of life St George Respiratory Questionnaire	31.65 units on a scale STANDARD_DEVIATION 18.86 • n=5 Participants	31.16 units on a scale STANDARD_DEVIATION 19.89 • n=7 Participants	31.40 units on a scale STANDARD_DEVIATION 19.27 • n=5 Participants
Minutes per day in Moderate and Vigorous Physical Activity	11.5 Minutes per day STANDARD_DEVIATION 13.43 • n=5 Participants	9.26 Minutes per day STANDARD_DEVIATION 9.35 • n=7 Participants	10.12 Minutes per day STANDARD_DEVIATION 11.02 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

Population: Intent to Treat population (all participants randomized to LTGO or EUC). Compare difference between groups in change of average steps per day between baseline and 3 months.

Outcome measures

Outcome measures
Measure	LTGO-Home Based Exercise n=44 Participants The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation. LTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement	Enhanced Usual Care n=44 Participants Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device. Enhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.
Physical Function- Walking: Change in Average Steps Per Day at Month 3	460 average steps per day Standard Deviation 3410	352 average steps per day Standard Deviation 2470

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Intent to Treat population (all surviving participants randomized to LTGO or EUC). Compare difference between groups in change of average steps per day between baseline and 6 months.

Walking was measured as the change in average steps per day calculated by FitBit worn for periods at baseline and 6 months. Minimum = 0, no upper limit. Higher scores indicate a better outcome. Change = (6 month score minus baseline score).

Outcome measures

Outcome measures
Measure	LTGO-Home Based Exercise n=41 Participants The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation. LTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement	Enhanced Usual Care n=44 Participants Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device. Enhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.
Physical Function- Walking: Change in Average Steps Per Day at Month 6	445 average steps per day Standard Deviation 2310	405 average steps per day Standard Deviation 3570

PRIMARY outcome

Timeframe: Baseline and 3 months.

Population: Intent to Treat population (all participants randomized to LTGO or EUC). Compare difference between groups in change of Berg Balance between baseline and 3 months.

Balance was measured as the change in Berg Balance Score at baseline and 3 months. This scale tests ability to handle tasks that require balance (e.g., sitting to standing, placing alternate foot on stool.) Minimum = 0, upper limit = 56. Higher scores indicate a better outcome. Change = (3 month score minus baseline score).

Outcome measures

Outcome measures
Measure	LTGO-Home Based Exercise n=44 Participants The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation. LTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement	Enhanced Usual Care n=44 Participants Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device. Enhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.
Physical Function- Balance: Change in Berg Balance at Month 3	0.48 units on a scale Standard Deviation 1.96	0.67 units on a scale Standard Deviation 1.67

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Intent to Treat population (all surviving participants randomized to LTGO or EUC). Compare difference between groups in change of Berg Balance between baseline and 6 months.

Balance was measured as the change in Berg Balance Score at baseline and 6 months. This scale tests ability to handle tasks that require balance (e.g., sitting to standing, placing alternate foot on stool.) Minimum = 0, upper limit = 56. Higher scores indicate a better outcome. Change = (6 month score minus baseline score).

Outcome measures

Outcome measures
Measure	LTGO-Home Based Exercise n=41 Participants The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation. LTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement	Enhanced Usual Care n=44 Participants Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device. Enhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.
Physical Function- Balance: Change From Baseline to 6 Months	1.71 units on a scale Standard Deviation 3.29	0.74 units on a scale Standard Deviation 1.73

PRIMARY outcome

Timeframe: Baseline and 3 months.

Population: Intent to Treat population (all participants randomized to LTGO or EUC). Compare difference between groups in change of 30-Second Chair Stand Test between baseline and 3 months.

Lower body strength was measured as the change in 30-Second Chair Stand Test at baseline and 3 months. The participant will be instructed to: 1) sit in the middle of a chair (17 inch height, with a straight back without armrests); 2) place hands on the opposite shoulder crossed at the wrists; 3) keep feet flat on the floor and back straight. On "Go," the participant will be asked to rise to a full standing position, sit down on the chair and repeat this move for 30 seconds. Minimum score =0 with no upper limit. More repetitions indicate better outcome. Change = (3 month score minus baseline score).

Outcome measures

Outcome measures
Measure	LTGO-Home Based Exercise n=44 Participants The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation. LTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement	Enhanced Usual Care n=44 Participants Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device. Enhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.
Physical Function-Lower Body Strength: Change From Baseline to 3 Months	0.964 repetitiions Standard Deviation 2.03	0.314 repetitiions Standard Deviation 2.18

PRIMARY outcome

Timeframe: Baseline and 6 months.

Population: Intent to Treat population (all surviving participants randomized to LTGO or EUC). Compare difference between groups in change of 30-Second Chair Stand Test between baseline and 6 months.

Lower body strength was measured as the change in 30-Second Chair Stand Test at baseline and 6 months. The participant will be instructed to: 1) sit in the middle of a chair (17 inch height, with a straight back without armrests); 2) place hands on the opposite shoulder crossed at the wrists; 3) keep feet flat on the floor and back straight. On "Go," the participant will be asked to rise to a full standing position, sit down on the chair and repeat this move for 30 seconds. Minimum score = 0 with no upper limit. More repetitions indicate better outcome. Change = (6 month score minus baseline score).

Outcome measures

Outcome measures
Measure	LTGO-Home Based Exercise n=41 Participants The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation. LTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement	Enhanced Usual Care n=44 Participants Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device. Enhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.
Physical Function-Lower Body Strength: Change From Baseline to 6 Months	1.5 repetitions Standard Deviation 2.53	1.11 repetitions Standard Deviation 3.29

PRIMARY outcome

Timeframe: Baseline and 3 months.

Population: Intent to Treat population (all participants randomized to LTGO or EUC). Compare difference between groups in change of SGRQ between baseline and 3 months.

Respiratory-related quality of life was measured as the change in the St. George Respiratory Questionnaire (SGRQ) at baseline and 3 months. The SGRQ is a 50-item self-report measure that assesses symptoms and activities that cause or are limited by breathlessness. Minimum score = 0 with 100 upper limit. Higher scores indicate worse outcomes. Change = (3 month score minus baseline score).

Outcome measures

Outcome measures
Measure	LTGO-Home Based Exercise n=44 Participants The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation. LTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement	Enhanced Usual Care n=44 Participants Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device. Enhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.
Physical Function- Respiratory-related Quality of Life Change From Baseline to 3 Months.	-4.64 units on a scale Standard Deviation 9.29	-6.45 units on a scale Standard Deviation 11.56

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Intent to Treat population (all surviving participants randomized to LTGO or EUC). Compare difference between groups in change of respiratory-related quality of life between baseline and 6 months.

Respiratory-related quality of life was measured as the change in the St. George Respiratory Questionnaire (SGRQ) at baseline and 6 months. The SGRQ is a 50-item self-report measure that assesses symptoms and activities that cause or are limited by breathlessness. Minimum score = 0 with 100 upper limit. Higher scores indicate worse outcomes. Change = (6 month score minus baseline score).

Outcome measures

Outcome measures
Measure	LTGO-Home Based Exercise n=41 Participants The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation. LTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement	Enhanced Usual Care n=44 Participants Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device. Enhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.
Physical Function- Respiratory-related Quality of Life: Change From Baseline to 6 Months.	-6.33 units on a scale Standard Deviation 11.26	-6.83 units on a scale Standard Deviation 8.38

PRIMARY outcome

Timeframe: Baseline and 3 months.

Population: Intent to Treat population (all participants randomized to LTGO or EUC). Compare difference between groups in change of MVPA between baseline and 3 months.

The number of minutes spent in moderate and vigorous physical activity per day was measured using the Actigraph, an accelerometer to monitor physical activity. The device provides tri-axial vector data in activity units, metabolic equivalent tasks (METs), or kilocalories. The participant will wear the Actigraph for 7 days (starting the following day) during waking hours (≥10 hours of wear/day). Minutes spent in moderate and vigorous physical activity (MVPA) is summed for MVPA minutes/day. Minimum score = 0 with no upper limit. Higher scores indicate better outcomes. Change = (3 month score minus baseline score).

Outcome measures

Outcome measures
Measure	LTGO-Home Based Exercise n=44 Participants The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation. LTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement	Enhanced Usual Care n=44 Participants Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device. Enhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.
Physical Activity-Minutes of Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 3 Months.	2.18 minutes per day Standard Deviation 7.37	1.17 minutes per day Standard Deviation 13.0

PRIMARY outcome

Timeframe: Baseline and 6 months.

Population: Intent to Treat population (all surviving participants randomized to LTGO or EUC). Compare difference between groups in change of MVPA between baseline and 6 months.

Outcome measures

Outcome measures
Measure	LTGO-Home Based Exercise n=41 Participants The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation. LTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement	Enhanced Usual Care n=44 Participants Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device. Enhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.
Physical Activity-Moderate to Vigorous Physical Activity Per Day: Change From Baseline to 6 Months.	2.38 minutes per day Standard Deviation 9.99	6.53 minutes per day Standard Deviation 21.6

SECONDARY outcome

Timeframe: Baseline and 3 months

Population: Intent to Treat population (all participants randomized to LTGO or EUC). Compare difference between groups in counts of participants with the same or improved stage of hypertension between baseline and 3 months.

Blood pressure control was measured as change in stage of hypertension. Systolic and diastolic blood pressure was assessed, then categorized from 1 (normal) to 4 (stage 3) according to the standard categories for hypertension. Change was calculated as stage at 3 months minus stage at baseline -3 to +3. Difference reported as the count of participants whose BP stage remained the same or improved between baseline and 3 months. A higher count indicates better outcome.

Outcome measures

Outcome measures
Measure	LTGO-Home Based Exercise n=44 Participants The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation. LTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement	Enhanced Usual Care n=44 Participants Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device. Enhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.
Blood Pressure Control-Change From Baseline to 3months	30 Participants	31 Participants

SECONDARY outcome

Timeframe: Baseline and 6 months.

Population: Intent to Treat population (all surviving participants randomized to LTGO or EUC). Compare difference between groups in counts of participants with the same or improved stage of hypertension between baseline and 6 months.

Blood pressure control was measured as change in stage of hypertension. Systolic and diastolic blood pressure was assessed, then categorized from 1 (normal) to 4 (stage 3) according to the standard categories for hypertension. Change was calculated as stage at 6 months minus stage at baseline -3 to +3. Difference reported as the count of participants whose BP stage remained the same or improved between baseline and 6 months. A higher count indicates better outcome.

Outcome measures

Outcome measures
Measure	LTGO-Home Based Exercise n=41 Participants The lung transplant recipient will receive LTGO- Home Based Exercise, a behavioral exercise intervention that consists of in-home exercise training integrated with behavioral coaching using tele-rehabilitation. LTGO-Home Based Exercise: The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement	Enhanced Usual Care n=44 Participants Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device. Enhanced Usual Care: Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.
Blood Pressure Control-Change From Baseline to 6 Months	30 Participants	24 Participants

Adverse Events

LTGO-Home Based Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Enhanced Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Annette DeVito Dabbs

University of Pittsburgh

Phone: 4126245314

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place