Exercise Training Post Burn Injury

NCT ID: NCT01368367

Last Updated: 2011-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Even though immediate and early death from severe thermal injury has reduced over the last twenty years, considerable physical and psychosocial morbidity still persists. While exercise is strongly recommended to assist recovery and overall outcome, there is limited evidence in adults to indicate whether it is effective and/or safe.

This study will investigate the effect of a high intensity aerobic and resisted exercise program exercise program on safety, physical, functional and quality of life measures in adults post burn injury.

Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intensive exercise group

Group Type ACTIVE_COMPARATOR

Intensive exercise

Intervention Type 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.

Stretch exercise only

Group Type PLACEBO_COMPARATOR

Intensive exercise

Intervention Type 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.

Interventions

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Intensive exercise

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Brisbane and Women's Hospital

OTHER_GOV

Sponsor Role collaborator

The University of Queensland

OTHER

Sponsor Role lead

Responsible Party

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University of Queensland

Locations

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Royal Brisbane & Womens Hospital

Brisbane, Queensland, Australia

Site Status

Countries

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Australia

Other Identifiers

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ETPB1

Identifier Type: -

Identifier Source: org_study_id

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