Longitudinal Study of Weight Change Following Lower Limb Amputation

Amputation Wound Clinical Trial

Official title:

Weight Change, Physical Activity and Health Promotion in Veteran Amputees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932399
• Other study ID #: F6982-W
• Status: Completed
• Phase: N/A
• First received: July 1, 2009
• Last updated: January 13, 2016
• Start date: March 2010
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess weight change in a population of Veterans with amputations. Little is known about the how weight changes following an amputation. It is widely believed that many patients experience weight gain following amputation. This study aims to identify magnitude of weight changes following amputation and determine characteristics associated with weight gain. Information on weight change trajectories would be useful to better understand long-term health consequences associated with amputation and to design and target interventions to encourage weight maintenance and general health promotion for groups at high risk of weight gain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4549
• Est. completion date: January 2016
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 27 Years to 89 Years

Eligibility

Inclusion Criteria:

"Exposed" cohort:

• incident lower limb amputation during the study period (1/1997-12/2008) in VISN 20

• >= 1 plausible weight recoded in the medical record at baseline (defined as 8 weeks before amputation or 2-8 weeks post amputation)

• >=1 weight measured post amputation (2 months to 42 months post amputation)

"Unexposed" (comparison) cohort:

• no lower limb amputation during the study period

• no prior history of amputation

• >= 2 plausible recorded weights including at least one in the 2-6 weeks after their reference date ("baseline").

• Alive at least 18 months after "baseline"

Exclusion Criteria:

• female (due to small number of women with lower limb amputations)

• lack information on any of the characteristics used for matching (e.g., birth year/age and height to calculate body mass index)

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Amputation Wound
• Amputation, Traumatic
• Body Weight Changes
• Dysvascular Amputation of Lower Limb
• Traumatic Amputation of Toe

Locations

Country	Name	City	State
United States	VA Puget Sound Health Care System Seattle Division, Seattle, WA	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bouldin ED, Thompson ML, Boyko EJ, Morgenroth DC, Littman AJ. Weight Change Trajectories After Incident Lower-Limb Amputation. Arch Phys Med Rehabil. 2016 Jan;97(1):1-7.e1. doi: 10.1016/j.apmr.2015.09.017. Epub 2015 Oct 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Weight Change From Baseline	Time window for 3 years is 31-39 months after baseline	At ~3 years after baseline	No