Motor ActivityNCT02473926
Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes
A study testing Physical Activity and Questionnaires in people with Motor Activity and Health Behavior, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about physical activity and physical function in sedentary older adults with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Motor Activity, Health Behavior, Diabetes Mellitus, Type 2
- What is being tested?
- Physical Activity and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 29 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes
- Sedentary individual, performing <20 minutes of physical activity on <3 days/week
Who cannot join
- Dementia (Folstein Mini-Mental Status Exam <24) or clinical diagnosis
- Excessive fall risk: Can not hold semi-tandem stance for >10 seconds
- Type 2 diabetes-related safety concerns: Prior diabetic foot ulcer, Charcot foot, asymptomatic hypoglycemia
- Severely uncontrolled hypertension (BP >180/100)
- Excessive hearing or visual impairment for counseling
- Limited life expectancy: Active treatment for malignancy
- Performs regular physical activity >20 minutes on >3 days/week
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver | Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
This study plans to learn more about physical activity and physical function in sedentary older adults with type 2 diabetes.
Read the detailed description
The purpose of this study is to conduct a randomized controlled trial with 1:1 patient-level randomization to an evidence-based physical activity program intervention versus usual care in sedentary older adults with type 2 diabetes in two primary care clinic sites.
- Conditions
- Motor Activity, Health Behavior, Diabetes Mellitus, Type 2
- Being tested
- Physical Activity, Questionnaires
- Keywords
- Physical Activity, Physical Function, Physical Impairment, Sedentary Lifestyle
- Medical subject headings
- Motor Activity, Health Behavior, Diabetes Mellitus, Type 2, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
Physical Activity Program Intervention
QuestionnairesBehavioural
Participants in the usual care arm will receive three mailings during the intervention phase.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Program Intervention | Experimental | The intervention seeks to increase physical activity and improve strength by addressing individual , behavioral, and social/environmental factors. Health promotion clinic staff will deliver counseling by phone on a bi-weekly basis - a clinic physician assistant will coordinate with the counselor during in-person clinic visits, teach participants to perform strengthening exercise, and assess for safety concerns associated with type 2 diabetes.
In addition to behavioral counseling targeting social cognitive theory constructs, counselors will assist participants in the intervention group to set specific goals for physical activity in a paper log and on an electronic FitBit activity tracking device.Health promotion clinic staff will encourage participants to advance goals towards meeting U.S. physical activity guidelines of 150 minutes/week of moderate intensity activity and 2-3 days/week of strength activities. Receives: Behavioral: Physical Activity |
| Usual Care Group | Other | Participants in the usual care arm will receive three mailings (Intervention Questionnaires) during the intervention phase. Health promotion clinic staff will mail materials from the Center for Disease Control and Prevention website that address general health aging topics. Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Objective Physical Activity at 4 Months
ActiGraph accelerometer measures physical activity objectively as steps/week. These data are presented as the change from baseline values.
Measured: Baseline, 4 Months
Secondary outcomes (2)
Change From Baseline in Physical Function at 4 Months
Measured via 400-meter rapid gait speed test. These data are presented as the change from baseline values, where decrease in numbers indicate a faster walking speed.
Measured: Baseline, 4 Months
Change From Baseline in Physical Function at 4 Months
Measured via the Short Physical Performance Battery (SPPB), which evaluates balance, usual walking speed, and repeated chair rise. These data are presented as the change from baseline values where higher values indicate better physical function (scoring range 0-12).
Measured: Baseline, 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2019
- Study completion29 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Amy Huebschmann, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473926
- Sponsor's protocol ID
- 15-1080
- Other IDs
- K23HL118133
- Status last verified
- Aug 2023
- First submitted
- 24 Apr 2015
- Last updated
- 21 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Huebschmann AG, Glasgow RE, Leavitt IM, Chapman K, Rice JD, Lockhart S, Stevens-Lapsley JE, Reusch JEB, Dunn AL, Regensteiner JG. Integrating a physical activity coaching intervention into diabetes care: a mixed-methods evaluation of a pilot pragmatic trial. Transl Behav Med. 2022 May 25;12(4):601-610. doi: 10.1093/tbm/ibac014.
PubMed 35312788
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02473926
- Acronym / sponsor ID
- 15-1080
- Conditions
- Motor Activity, Health Behavior, Diabetes Mellitus, Type 2
- Keywords
- Physical Activity, Physical Function, Physical Impairment, Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2015 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- 29 Jul 2019 (actual)
- First posted
- 17 Jun 2015 (estimated)
- Results
- Posted 21 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study plans to learn more about physical activity and physical function in sedentary older adults with type 2 diabetes.
Detailed description
The purpose of this study is to conduct a randomized controlled trial with 1:1 patient-level randomization to an evidence-based physical activity program intervention versus usual care in sedentary older adults with type 2 diabetes in two primary care clinic sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Program Intervention | Experimental | Behavioral: Physical ActivityThe intervention seeks to increase physical activity and improve strength by addressing individual , behavioral, and social/environmental factors. Health promotion clinic staff will deliver counseling by phone on a bi-weekly basis - a clinic physician assistant will coordinate with the counselor during in-person clinic visits, teach participants to perform strengthening exercise, and assess for safety concerns associated with type 2 diabetes. In addition to behavioral counseling targeting social cognitive theory constructs, counselors will assist participants in the intervention group to set specific goals for physical activity in a paper log and on an electronic FitBit activity tracking device.Health promotion clinic staff will encourage participants to advance goals towards meeting U.S. physical activity guidelines of 150 minutes/week of moderate intensity activity and 2-3 days/week of strength activities. |
| Usual Care Group | Other | Behavioral: QuestionnairesParticipants in the usual care arm will receive three mailings (Intervention Questionnaires) during the intervention phase. Health promotion clinic staff will mail materials from the Center for Disease Control and Prevention website that address general health aging topics. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of type 2 diabetes
- Sedentary individual, performing <20 minutes of physical activity on <3 days/week
Key exclusion criteria (7 listed)
- Dementia (Folstein Mini-Mental Status Exam <24) or clinical diagnosis
- Excessive fall risk: Can not hold semi-tandem stance for >10 seconds
- Type 2 diabetes-related safety concerns: Prior diabetic foot ulcer, Charcot foot, asymptomatic hypoglycemia
- Severely uncontrolled hypertension (BP >180/100)
- Excessive hearing or visual impairment for counseling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityPhysical Activity Program Intervention | Behavioural | Physical Activity Program Intervention |
| QuestionnairesParticipants in the usual care arm will receive three mailings during the intervention phase. | Behavioural | Usual Care Group |
Primary outcome
Change From Baseline in Objective Physical Activity at 4 Months
Time frame: Baseline, 4 Months
ActiGraph accelerometer measures physical activity objectively as steps/week. These data are presented as the change from baseline values.
2 secondary outcomes
Change From Baseline in Physical Function at 4 Months
Time frame: Baseline, 4 Months
Change From Baseline in Physical Function at 4 Months
Time frame: Baseline, 4 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35312788Huebschmann AG, Glasgow RE, Leavitt IM, Chapman K, Rice JD, Lockhart S, Stevens-Lapsley JE, Reusch JEB, Dunn AL, Regensteiner JG. Integrating a physical activity coaching intervention into diabetes care: a mixed-methods evaluation of a pilot pragmatic trial. Transl Behav Med. 2022 May 25;12(4):601-610. doi: 10.1093/tbm/ibac014.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Huebschmann, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity and Questionnaires in people with Motor Activity and Health Behavior, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Objective Physical Activity at 4 Months (time frame: Baseline, 4 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02473926, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.