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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583257
• Other study ID #: CDHA-AVG2012
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 20, 2012
• Last updated: May 14, 2015
• Start date: June 2012
• Est. completion date: June 2013

Study information

• Verified date: May 2015
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment

Related Conditions & MeSH terms

• Quality of Life

Intervention

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

Locations

Country	Name	City	State
Canada	QEII Health Sciences Center, MOTP	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	Novartis Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No