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Completed

NCT Number: NCT02061579

Initiate and Maintain Physical Activity in Clinics: The IMPACT Diabetes Study

The Initiate and Maintain Physical Activity in Clinics (IMPACT) study will determine the optimal and feasible level of frequency of structured contact needed in a clinical setting for adult patients with Type 2 Diabetes Mellitus to initiate and maintain physical activity recommendations long-term.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94304, United States

About this study

The IMPACT Study will compare the health outcomes and lifestyle habits amongst the three groups of study participants. Study participants will be randomized into three exercise group. Group 1 will participate in instructor-led exercise training sessions 1 time per week, for 24 weeks (approximately 6 months). Group 2 will participate in instructor-led exercise training sessions 3 times per week, for 24 weeks (approximately 6 months). Group 3 will not attend any instructor-led exercise training sessions. All groups will be encouraged to see their usual providers for routine healthcare, and continue their usual medication regimen.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Recent hemoglobin A1c result between 6.5 and 13.0%
  • Diagnosed with Type 2 Diabetes Mellitus
  • Able and willing to enroll and meet the requirements of the study

Exclusion criteria

  • Inability to speak, read or understand English
  • Long-term current use or dependency on insulin
  • Systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg
  • Resting heart rate > 120 bpm
  • History of or present heart or cardiovascular conditions
  • History of or present respiratory disease
  • History of or present spinal cord injury
  • History of stroke or Transient Ischemic Attack (TIA)
  • History of cancer diagnosis in the past 5 years or present cancer diagnosis
  • Medical, psychiatric, behavioral limitations that may interfere with study participation
  • Participating in other clinical trials that may interfere with study procedures and outcomes
  • Currently pregnant or plans to become pregnant within three years

Treatment and study plan

Structured Group Exercise

Behavioral

The study intervention is a 6-month exercise program with structured group sessions conducted in a clinical setting. Group sessions include Aerobic Training and Combined Training. Once-Weekly participants will attend one Combined Training session while thrice-weekly participants will attend two Combined Training sessions and one Aerobic Training session per week. Participants in both groups will attend three exercise evaluations during the intervention period. Participants will also use provided logs to track their daily exercise activities outside of group sessions. Physical activity will be assessed by group session attendance, exercise resistance and intensity, and exercise frequency data collected from exercise logs, surveys, and evaluations.

Primary outcomes

  1. Changes in Hemoglobin A1c Level Across Study Visits

    Time frame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up

  2. Changes in Maximal Oxygen Consumption Across Study Visits

    Time frame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up

  3. Changes in Self-Reported Physical Activity Level Across Study Visits

    Time frame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up

Secondary outcomes

  1. Changes in Body Weight Across Study Visits

    Time frame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up

  2. Changes in Body Mass Index Across Study Visits

    Time frame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up

  3. Changes in Waist Circumference Across Study Visits

    Time frame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up

  4. Changes in Blood Pressure Across Study Visits

    Time frame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up

  5. Changes in Heart Rate Across Study Visits

    Time frame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up

  6. Changes in Dietary Intake Across Study Visits

    Time frame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up

  7. Changes in Self-Reported Quality of Life Across Study Visits

    Time frame: Baseline, 3-, 6-, 18-, 24-, 30-month follow-up

  8. Changes in Exercise Perception Across Study Visits

    Time frame: Baseline, 6-, 30-month follow-up

  9. Changes in Patient Satisfaction During Intervention Period

    Time frame: 3-, 6-month follow-up

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: IMPACT

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Feb 13, 2014
Registry last updated
Mar 17, 2021

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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