Pilot Study: Active Video Gaming to Facilitate Physical Activity and Quality of Life in Kidney Transplant Recipients

NCT01583257 | Completed Phase 1

• 1 other identifier: CDHA-AVG2012
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Renal transplant recipients have a greater risk of morbidity and mortality primarily due to cardiovascular disease when compared to the general population. Cardiovascular disease is responsible for 50% to 60% percent of deaths amongst renal transplant population and death from cardiovascular disease is a leading cause of functioning graft loss. Physical activity is an effective form of secondary prevention in existing cardiovascular disease reducing all-cause mortality by 25%-30% and has demonstrated positive effects overall on quality of life and well-being. Transplant patients who participated in regular cardiovascular exercise have significant more positive scores on the SF-36 Health Status Questionnaire in comparison to inactive transplant recipients. Active video gaming is evolving as an innovative method to increase physical activity. Active video gaming has supported physical activity in children and youth. There is however a paucity of literature examining interactive games as a means to facilitate physical activity and its impact on CVD and quality of life in the adult population nor any literature examining AVG and its impact on an adult surgical population. This pilot study is designed to determine if Active Video Gaming is feasible and is able to lead to behavioral modifications and Quality of Life improvement. Subject Selection: This is a pilot study during which 10 patients who have undergone renal transplant will be selected to exercise with Active Video Gaming for a duration of 3 months. The program activity will begin 6 months post surgery.

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

• Quality of Life

  Quality of life will be measured at baseline and upon completion of the intervention using a standard questionnaire.

  3 months post intervention

Study Arms (1)

Active Video Gaming

EXPERIMENTAL

An active gaming exercise workout will be provided with QoL measured at baseline and following the 8 week workout schedule. The workout will use the Microsoft Kinect (TM) system with EA Sports Active 2 program.

Behavioral: Workout based on active video gaming

Interventions

Workout based on active video gaming BEHAVIORAL

A personalized workout regimen will be provided using the Microsoft Kinect Active Gaming Console with EA Sports Active 2 program

Also known as: Microsoft Kinect, EA Sports Active 2

Active Video Gaming

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Renal transplant patient who want and are able to take part in this study

You may not qualify if:

• Cardiac or pulmonary dysfunction diagnosed through preoperative assessment.
• Any surgical complication incurred with transplantation.
• Peripheral vascular disease.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

QEII Health Sciences Center, MOTP

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Study Officials

• Ian P Alwayn, MD, PhD

  CDHA / Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: April 23, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: May 15, 2015

Record last verified: 2015-05

Locations

CA (1)