The Efficacy of Physical Activity on Improving Health Outcomes for Renal Transplant Patients

NCT04054323 | Withdrawn

• 1 other identifier: PRO18080372
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see whether a physical activity intervention improves fitness, strength and reduces sedentary behavior. The investigators are also interested in determining if changes will improve quality of life and outcomes associated with renal transplant waitlist.

Conditions

Chronic Kidney Diseases

Keywords

Exercise; CKD; Graft Survival; Transplant Waitlist

Outcome Measures

Primary Outcomes (1)

• Change of Gate Speed from Baseline vs. 6 months

  Measured as meters/second

  Baseline vs. 6 months

Secondary Outcomes (2)

• International Physical Activity Questionnaire

  Baseline vs. 6 months

• Medical Outcome Survey - Short Form 36

  Baseline vs. 6 months

Study Arms (2)

Patient Physical Activity Arm

EXPERIMENTAL

Patients only receive physical activity intervention.

Behavioral: Physical Activity Intervention

Dyadic Physical Activity Arm

EXPERIMENTAL

Patients and caregivers both receive physical activity intervention.

Behavioral: Physical Activity Intervention

Interventions

Physical Activity Intervention BEHAVIORAL

The physical activity intervention will include basic skill training during which the participant will be instructed on the use of (1) the activPAL physical activity device for the tracking of time spent sitting, standing, and walking, (2) tools to monitor exercise intensity, including ratings of perceived exertion, (3) an exercise calendar for setting a specific schedule for the completion of the home exercise program using the exercise videos posted on our website, (4) use of the exercise equipment that will be used in the home program (Therabands), and (5) strategies for reduction of sedentary behavior that target prolonged sitting and encourages frequent activity breaks. Duration of intervention is 6 months.

Dyadic Physical Activity Arm; Patient Physical Activity Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient:
• Waitlisted for renal transplant
• =\>21 years of age
• Caregiver:
• Primary caregiver for patient
• =\>21 years of age

You may not qualify if:

• Patient:
• Active suicidal ideation
• Thought disorder
• Delusions
• Hallucinations
• Recent myocardial infarction, heart attack, or stroke
• Planned elective surgeries for joint replacement
• Caregiver:
• Active suicidal ideation
• Thought disorder
• Delusions
• Hallucinations
• Recent myocardial infarction, heart attack, or stroke
• Planned elective surgeries for joint replacement

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Motor Activity

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Jennifer Steel, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 13, 2019
• Study Start: April 2, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: October 22, 2024

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)