Physical Activity and Participation

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Veterans With Diabetes Mellitus: Improving Physical Activity and Participation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268916
• Other study ID #: O1190-W
• Status: Completed
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2022
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to investigate if the investigators can improve physical activity and social participation level among Veterans with diabetes.

Description:

Physical activity is the cornerstone of good diabetes management, and yet effective physical activity intervention is not available. The investigators developed a lifestyle intervention based on individual's home activity patterns. The goal of the study is to test the efficacy of this intervention among Veterans with diabetes in a randomized-controlled trial. In addition to physical activity, the investigators will also assess if the intervention will improve social participation among Veterans.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Veterans

• Aged 60 years or older

• Has Type 2 diabetes mellitus

• Able to operate accelerometer

• Competent to consent to the study

• No dementia diagnosis

• Ambulatory with or without assistive device

• English-speaking

• Community living (i.e., not a nursing home resident)

• Not physically active on a regular basis (less than 150 minutes of moderate or vigorous physical activity per week)

Exclusion Criteria:

• Medically unstable

• Hospitalized within the last 6 months

• 2 or more days of complete bed rest in the last month

• hemiplegia or limb amputation

• Self-reported illness or conditions that would impair the cooperation with the study team or the ability to complete the study

• work involved in shift schedule

• current enrollment of a physical activity program

• replacement of hip or knee within the last 6 months.

• Parkinson's disease

• frequent falls

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Counseling
OT led counseling
• Usual education
At the end of the study, will receive OT-led counseling

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical Function	Six month changes in timed up and go test, where the participant get up from sitting in a chair, walk meters, turn around, and walk back to sit down. Positive changes means worse outcome for timed up and go (seconds).	6 months
Other	Physical Function	Six month changes in gait speed, which is the comfortable gait peed in 10 meter walking. Positive changes means better outcomes for gait speed (meters per second).	6 months
Other	Physical Function	Six month changes in six-minute walk test, which measures the distance a participant walked at usual pace for six minutes. Positive changes means better outcomes for six-minute walk (meters).	6 months
Primary	Physical Activity	Home physical activity changes from baseline to 6-months.Physical activity was measured using a validated survey called CHAMPS, asking the participants to report activities that they participated in a typical week, such as walking, doing house work, dancing, etc.	6 months
Primary	Social Participation	Survey questionnaires of participation change from baseline to 6-months follow up, specifically, satisfaction with participation in social roles, satisfaction with participation in discretionary social activities, and ability to participate in social roles and activities. Each survey has been validated and scored on the T-score metrics. A T-score is a standardized score, and has a "middle" score; it is 50 for T-scores. This middle score is the mean of a large sample that is representative of the US general population. The survey results are T-score metrics in which 50 is the mean score of the general population and 10 is the standard deviation (SD) of that population. The study outcomes are changes in T-scores of each survey from baseline to 6-months follow-up, where positive score means improved outcome, and negative score means worse outcome at 6-months.	6 months