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

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ClinicalTrials.gov Identifier: NCT02061579
Recruitment Status : Active, not recruiting
First Posted : February 13, 2014
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Latha Palaniappan, MD, MS, 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: Structured Group Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Initiate and Maintain Physical Activity in Clinics: The IMPACT Diabetes Study
Actual Study Start Date : October 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Once-Weekly Structured Contact
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.
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.

Experimental: Thrice-Weekly Structured Contact
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.
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.

No Intervention: Usual Care
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061579


Locations
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United States, California
Stanford University
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University

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Responsible Party: Latha Palaniappan, MD, MS, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02061579     History of Changes
Other Study ID Numbers: 31635
U.S. NIH Grant 5R18DK096394 ( Other Grant/Funding Number: U.S. NIH Grant/Contract Award Number )
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

Keywords provided by Latha Palaniappan, MD, MS, Stanford University:
Physical Activity

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases