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Completed

NCT Number: NCT02268916

Physical Activity and Participation

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

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Key information

Conditions

Type 2 Diabetes Mellitus Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling

Behavioral

OT led counseling

Usual education

Behavioral

At the end of the study, will receive OT-led counseling

Primary outcomes

  1. Physical Activity

    Time frame: 6 months

    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.

  2. Social Participation

    Time frame: 6 months

    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.

Other outcomes

  1. Physical Function

    Time frame: 6 months

    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).

  2. Physical Function

    Time frame: 6 months

    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).

  3. Physical Function

    Time frame: 6 months

    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).

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Veterans With Diabetes Mellitus: Improving Physical Activity and Participation

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 20, 2014
Registry last updated
Sep 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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