Exercise Training Post Burn Injury

NCT01368367 | Unknown

• 1 other identifier: ETPB1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a high intensity aerobic and resisted exercise program will improve physical, functional and psychological outcomes in patients post burn injury.

Conditions

Burns

Keywords

Burns

Outcome Measures

Primary Outcomes (1)

• Burns Specific Health Scale - Abbreviated (BSHS-A)

  The BSHS-A is an injury specific self reported questionnaire consisting of 80 questions encompassing four primary domains namely physical, psychological, social and general, with reports of good internal consistency, test/ retest reliability and strong convergent validity data.

  Change from baseline to six weeks, change from 6 weeks to 12 weeks

Secondary Outcomes (7)

• The modified shuttle walk test (MSWT)

  Change from baseline to six weeks, change from 6 weeks to 12 weeks

• VO2peak (ie the volume of oxygen consumed by the cells at the most intensive level during the exercise test)

  Change from baseline to six weeks, change from 6 weeks to 12 weeks

• Resting heart rate (beats/minute)

  Change from baseline to six weeks, change from 6 weeks to 12 weeks

• Muscle strength

  Change from baseline to six weeks, change from 6 weeks to 12 weeks

• Grip strength

  Change from baseline to six weeks, change from 6 weeks to 12 weeks

Study Arms (2)

Intensive exercise group

ACTIVE COMPARATOR

Other: Intensive exercise

Stretch exercise only

PLACEBO COMPARATOR

Other: Intensive exercise

Interventions

Intensive exercise OTHER

Both groups, stretching exercise monitored once per week Intensive exercise group An aerobic and resisted exercise program for a minimum of three times per week for a total of approximately 60 minutes per session for six weeks. Aerobic exercise will be conducted on a treadmill, exercise bike or arm ergometer at an intensity of 80 % of VO2peak during initial assessment. For resistance exercise, the three repetition maximum (3RM) (maximum weight able to be lifted a maximum of 3 times) will be established and then resisted exercise will be commenced at 60% of the 3RM in the first week. Resisted exercise will then be progressed weekly by 5-10% by increasing the number of repetitions or the weights lifted. All resisted exercises will be done using variable resistance machines or free weights.

Intensive exercise group; Stretch exercise only

Eligibility Criteria

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

You may qualify if:

• Burns greater than 20% total body surface area
• years of age and over
• English speaking
• Post final grafting procedure

You may not qualify if:

• Accompanying anoxic brain injury
• Cardiac disease or injury (American College of Sports medicine ACSM criteria)
• Quadriplegia
• Severe behaviour or cognitive disorders
• Compassionate care only

Sponsors & Collaborators

• The University of Queensland: lead
• Royal Brisbane and Women's Hospital: collaborator

Study Sites (1)

Royal Brisbane & Womens Hospital

Brisbane, Queensland, 4029, Australia

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 27, 2011
• First Posted: June 7, 2011
• Study Start: December 1, 2007
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 7, 2011

Record last verified: 2010-11

Locations

AU (1)