Clinical trial NCT06886256: Prehabilitation for Kidney Transplant Candidates
Official title: Enabling Access to Prehabilitation for Kidney Transplant Candidates Who Are Frail
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Transplantation
Frailty
Chronic Kidney Insufficiency
Keywords: Kidney Transplantation
Frailty
Chronic Kidney Insufficiency
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 15
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This interventional trial seeks to determine the feasibility of wearable sensors to provide data from patients while undergoing supervised exercise.

Detailed description: This pilot study is a prospective, non-randomized, interventional trial of measures of prehabilitation in kidney transplant candidates who are frail. Kidney transplant candidates who meet criteria for the study will have wearable sensors placed for monitoring during the exercise session of their prehabilitation. The sensors will capture data during the single exercise session and transfer the data to a mobile health (mHealth) platform. The study aims to use the information from the sensors to develop future studies where the exercise is adjusted based on the sensor reports.

Eligibility criteria: Inclusion Criteria:

1. Adult Frail patients who are being evaluated for kidney transplant at Houston Methodist Hospital
2. Male or Female, aged 55 or older
3. Provision of signed and dated informed consent by the participant
4. Willingness to comply with study procedures and the duration of the study

Exclusion Criteria:

1. Inability or contraindication to exercise
2. Refusal to participate
3. Inability to consent or effectively communicate

Primary outcomes:
measure: The proportion of patients who achieve at least 20 minutes of moderate-intensity exercise during a 1-hour physical therapy session at Visit 2 is greater than 75%.
timeFrame: Day 1
Secondary outcomes:
measure: Muscle strength - Grip strength
timeFrame: Baseline
measure: Muscle strength - Chair stand test
timeFrame: Baseline
measure: Physical performance - Gait speed
timeFrame: Baseline
measure: Physical performance - Timed up and go
timeFrame: Baseline
measure: Physical performance - Walking test, 6-minute walk
timeFrame: Baseline
measure: Physical performance - Walking test, 5-meter walk
timeFrame: Baseline
measure: Respiratory capacity - Maximal inspiratory pressure
timeFrame: Baseline
measure: Respiratory capacity - Adjust Inspiratory Muscle Trainer completion
timeFrame: Baseline
measure: Physical therapy - Aerobic exercise
timeFrame: Day 1
measure: Physical therapy - Resistance exercise
timeFrame: Day 1
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital System
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Atyia Dhala, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lorenz EC, Hickson LJ, Weatherly RM, Thompson KL, Walker HA, Rasmussen JM, Stewart TL, Garrett JK, Amer H, Kennedy CC. Protocolized exercise improves frailty parameters and lower extremity impairment: A promising prehabilitation strategy for kidney transplant candidates. Clin Transplant. 2020 Sep;34(9):e14017. doi: 10.1111/ctr.14017. Epub 2020 Jul 24.
citation: Yamagami M, Mack K, Mankoff J, Steele KM. "I'm Just Overwhelmed": Investigating Physical Therapy Accessibility and Technology Interventions for People with Disabilities and/or Chronic Conditions. ACM Transactions on Accessible Computing. 2022;15(4):1-22. doi: doi.org/10.1145/3563396.