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

Diabetes Mellitus Clinical Trial

— IMPACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02061579
• Other study ID #: 31635
• Secondary ID: U.S. NIH Grant 5
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: January 2020

Study information

• Verified date: March 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Structured Group Exercise
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.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Hemoglobin A1c Level Across Study Visits		Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Primary	Changes in Maximal Oxygen Consumption Across Study Visits		Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Primary	Changes in Self-Reported Physical Activity Level Across Study Visits		Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Secondary	Changes in Body Weight Across Study Visits		Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Secondary	Changes in Body Mass Index Across Study Visits		Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Secondary	Changes in Waist Circumference Across Study Visits		Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Secondary	Changes in Blood Pressure Across Study Visits		Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Secondary	Changes in Heart Rate Across Study Visits		Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Secondary	Changes in Dietary Intake Across Study Visits		Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Secondary	Changes in Self-Reported Quality of Life Across Study Visits		Baseline, 3-, 6-, 18-, 24-, 30-month follow-up
Secondary	Changes in Exercise Perception Across Study Visits		Baseline, 6-, 30-month follow-up
Secondary	Changes in Patient Satisfaction During Intervention Period		3-, 6-month follow-up