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

Stanford University

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Behavioral: Structured Group Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02061579

31635

U.S. NIH Grant 5R18DK096394 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 354 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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354 participants in 3 patient groups

Once-Weekly Structured Contact

Experimental group

Description:

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.

Treatment:

Behavioral: Structured Group Exercise

Thrice-Weekly Structured Contact

Experimental group

Description:

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.

Treatment:

Behavioral: Structured Group Exercise

Usual Care

No Intervention group

Description:

Participants in the Usual Care group will not take part in an 6-month exercise intervention. They will continue to seek regular care from their primary care providers and attend six study visits.