Prehabilitation for Adults With End Stage Renal Disease on the Kidney Transplant Waitlist

NCT02895243 | Completed

• 1 other identifier: IRB00006786
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will be a clinical trial to test the feasibility and effectiveness of a kidney transplant (KT) prehabilitation intervention in adults with end stage renal disease (ESRD) who are within 3-6 months of transplantation.

Conditions

Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

• Post kidney transplant mortality

  1 year patient survival

  1 year

Study Arms (1)

Prehabilitation

EXPERIMENTAL

Other: Prehabilitation

Interventions

Prehabilitation OTHER

The study will use a generic prehabilitation program which will include the following components: Warm-up, cardiovascular training, strength training, flexibility training, and cool down. Prehabilitation will occur once per week and approximately 1 hour in duration. Participants will take part in prehabilitation until they receive a kidney transplant which by study design is approximately for 3-6 months.

Also known as: exercise training

Prehabilitation

Eligibility Criteria

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

You may qualify if:

• Men and women with end stage renal disease who are within 3-6 months of kidney transplantation and are on the kidney transplant waitlist at Johns Hopkins
• Must be at least 18 years or older at enrollment
• Must be English speaking
• Must be enrolled in an ongoing cohort study of adults with ESRD who are being evaluated for kidney transplantation
• Must be willing to participate in a prehabilitation program and able to give informed consent

You may not qualify if:

• Patients who have any of the following medical conditions will be excluded from the study:
• Active Angina pectoris
• Chronic lung disease and daily use of oxygen
• Cerebral vascular disease
• Musculoskeletal conditions that would limit participation in prehabilitation
• Lower- or upper-extremity amputation
• Orthopedic disorders exacerbated by physical activity
• Decreased mental capacity
• Patients who live outside of Maryland will not be included in the study.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead

Study Sites (1)

Johns Hopkins Physical Medicine and Rehabilitation

Lutherville, Maryland, 21093, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Preoperative Exercise; Exercise

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mara McAdams DeMarco, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 9, 2016
• Study Start: May 27, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)