Increasing Activity in Liver Transplant Patients

NCT02058498 | Completed Results

• 1 other identifier: 13-004699
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Will adult liver transplant patients who are provided with physical activity (walking) instructions increase their physical activity and perceive an improved quality of life?

Conditions

Liver Transplant

Keywords

Liver transplant; Physical Activity; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ)

  The IPAQ calculates the metabolic equivalent (MET) score by asking participants the days and minutes exercised in three categories of intensity (vigorous, moderate, and walking) during the previous one week. The following formula is used to calculate the MET: MET=8(vigorous activity) (minutes) + 4 (moderate activity)(minutes) +3.3 (walking activity) (minutes).

  Baseline, 6 weeks

Secondary Outcomes (2)

• Quality of Life at Baseline, 6 Weeks, and 4 Months

  Baseline, 6 weeks, 4 months

• Number of Patients Who Document Their Physical Activity

  Baseline to 6 weeks, repeated measure at 4 months

Study Arms (1)

Liver Transplant Patients

EXPERIMENTAL

Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.

Behavioral: Physical activity

Interventions

Physical activity BEHAVIORAL

Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months.

Liver Transplant Patients

Eligibility Criteria

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

You may qualify if:

• Adult patients 18-65 years of age who receive a liver transplant at Mayo Clinic Jacksonville.
• Adult patients who are 5-21 days post liver transplant.
• Must be followed by Mayo Clinic Jacksonville at 4 months postoperatively.
• Approved by a hepatologist and/or transplant surgeon to participate.

You may not qualify if:

• Patients with active infections
• Patients with encephalopathy or cognitive dysfunction
• Patients who receive a combined liver-kidney transplant
• Patients with severe debility
• Patients who require assistance to ambulate.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Jennifer Serotta, DNP, ARNP
• Organization: Mayo Clinic Jacksonville

serotta.jennifer@mayo.edu

904-956-3200

Study Officials

• Jennifer Serotta, ARNP

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ARNP, FNP-BC

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 10, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 6, 2016
• Results First Posted: June 6, 2016

Record last verified: 2016-04

Locations

US (1)