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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Capital District Health Authority, Canada.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01583257
First received: April 20, 2012
Last updated: July 13, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Quality of Life
Behavioral: Workout based on active video gaming
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Official Title: Pilot Study: Active Video Gaming to Facilitate Physical Activity and Quality of Life in Kidney Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: 3 months post intervention ] [ Designated as safety issue: No ]
    Quality of life will be measured at baseline and upon completion of the intervention using a standard questionnaire.


Estimated Enrollment: 10
Study Start Date: June 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Video Gaming
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
A personalized workout regimen will be provided using the Microsoft Kinect Active Gaming Console with EA Sports Active 2 program
Other Names:
  • Microsoft Kinect
  • EA Sports Active 2

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Cardiac or pulmonary dysfunction diagnosed through preoperative assessment.
  • Any surgical complication incurred with transplantation.
  • Peripheral vascular disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583257

Contacts
Contact: Ian P Alwayn, MD, PhD 902-473-6193 ian.alwayn@cdha.nshealth.ca

Locations
Canada, Nova Scotia
QEII Health Sciences Center, MOTP Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Ian P Alwayn, MD, PhD    902-473-6193    ian.alwayn@cdha.nshealth.ca   
Principal Investigator: Ian P Alwayn, MD, PhD         
Sponsors and Collaborators
Capital District Health Authority, Canada
Novartis Pharmaceuticals
Investigators
Principal Investigator: Ian P Alwayn, MD, PhD CDHA / Dalhousie University
  More Information

No publications provided

Responsible Party: Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01583257     History of Changes
Other Study ID Numbers: CDHA-AVG2012
Study First Received: April 20, 2012
Last Updated: July 13, 2012
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on October 22, 2014