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Prescription exercise for Older men with Urinary Disease (PROUD) pilot study

Award Number: R01DK135804
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/15/2023
PERIOD OF PERFORMANCE END DATE: 03/31/2027

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Prescription exercise for Older men with Urinary Disease (PROUD) pilot study - PROJECT SUMMARY/ABSTRACT One in 3 American men will develop bothersome lower urinary tract symptoms in their lifetime, and the majority will be attributed to benign prostatic hyperplasia (LUTS/BPH). Older men with LUTS/BPH have increased risk of developing new mobility limitations, falls, fractures, disability, and death. Unfortunately, current LUTS/BPH medications targeting prostate-centric mechanisms likely further increase risk of some of these adverse clinical outcomes, have modest efficacy, and poor adherence. Frailty-related mechanisms are novel LUTS/BPH intervention targets that may be preventable or modifiable via an exercise intervention. Our team has previously created an individualized, remotely-monitored, and home-based exercise program based on well- known behavioral change principles and prioritization of scalable interventions requiring minimal equipment for older men with prostate cancer. However, a pilot study is required to determine the feasibility and optimal trial design for testing this exercise intervention in physically inactive older men with LUTS/BPH. We therefore propose a single-center pilot randomized controlled trial among 68 physically inactive older men with LUTS/BPH of a 12-week multicomponent exercise intervention versus health education control. The exercise intervention includes personalized written and pictorial instructions on aerobic and resistance exercises, supported by weekly one-on-one coaching by phone or video call, along with heart rate monitor biofeedback and the provision of limited equipment. The following aims must be addressed prior to conducting an adequately powered efficacy trial: Aim 1: Evaluate the feasibility, acceptability, fidelity, and safety of a remote exercise intervention and health education control among physically inactive older men with LUTS/BPH (N=68 total) 34/arm); Aim 2: Assess the magnitude, variability, and durability of changes in LUTS, urologic and physical function, and actigraphy measures after a 12-week exercise intervention or health education control; and Aim 3: Assess the feasibility of detecting exercise-induced change in novel frailty-related mechanistic measures (total muscle mass, mitochondrial function, urine α1-microglobulin). This project is innovative because it leverages a remote exercise intervention with pleotropic and systemic effects across multiple organ systems, in contrast to existing prostate-centric pharmacological and surgical therapies with side effects that are critical to avoid in older men. Our project will accomplish the extensive feasibility work that is required for both a future efficacy trial and the frailty-related mechanistic biomarker measurements. This pilot study is an important step towards an extended, fully-powered efficacy trial with a secondary focus on frailty-related mechanisms of an exercise intervention for treating LUTS/BPH. This future efficacy trial has the potential to transform both the clinical care for physically inactive older men with LUTS/BPH while simultaneously increasing our understanding of how exercise affects frailty-related LUTS/BPH mechanisms.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST # 151	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	1/5/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $350,886 )
2025	2025	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST # 151	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	5/7/2025	NON-COMPETING CONTINUATION	$350,886
														Subtotal = $350,886

Issue Date FY: 2024 ( Subtotal = $336,718 )
2024	2024	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST # 151	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	6/5/2024	NON-COMPETING CONTINUATION	$336,718
														Subtotal = $336,718

Issue Date FY: 2023 ( Subtotal = $342,482 )
2023	2023	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	5/10/2023	NEW	$342,482
2023	2023	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	6/7/2023	NEW	$0
														Subtotal = $342,482

Grand Total All Awards = $1,030,086

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Prescription exercise for Older men with Urinary Disease (PROUD) pilot study

Award Number: R01DK135804

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/15/2023

PERIOD OF PERFORMANCE END DATE: 03/31/2027

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