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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: Structured Group Exercise

• Registration Number: NCT02061579
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-13
• Study Start: 2016-10
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 354

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Once-Weekly Structured Contact	Structured Group Exercise	Participants in the Once Weekly Structured Contact group will take part in an 6-month exercise intervention and attend one structured group exercise session per week. They will engage in aerobic and resistance training for approximately 80 minutes per exercise session. Additionally, they will attend three exercise evaluations and six study visits.
Thrice-Weekly Structured Contact	Structured Group Exercise	Participants in the Thrice-Weekly Structured Contact group will take part in an 6-month exercise intervention and attend three structured group exercise sessions per week. In total, they will engage in aerobic and resistance training sessions for approximately 200 minutes per week. Additionally, they will attend three exercise evaluations and six study visits.

Primary Outcome Measures

Name	Time	Method
Changes in Hemoglobin A1c Level Across Study Visits	Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Maximal Oxygen Consumption Across Study Visits	Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Self-Reported Physical Activity Level Across Study Visits	Baseline, 3-, 6-, 18-, 24-, 30-month follow-up

Secondary Outcome Measures

Name	Time	Method
Changes in Heart Rate Across Study Visits	Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Self-Reported Quality of Life Across Study Visits	Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Body Mass Index Across Study Visits	Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Blood Pressure Across Study Visits	Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Body Weight Across Study Visits	Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Waist Circumference Across Study Visits	Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Changes in Exercise Perception Across Study Visits	Baseline, 6-, 30-month follow-up
Changes in Patient Satisfaction During Intervention Period	3-, 6-month follow-up
Changes in Dietary Intake Across Study Visits	Baseline, 3-, 6-, 18-, 24-, 30-month follow-up

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States