This trial is no longer recruiting

Recruitment for this study has ended, so applications are closed. You can still read the trial details, or browse similar trials that are currently recruiting.

Not recruiting

Sedentary Behavior

Sponsor:

University of Minnesota

Code:

NCT05838586

Conditions

Type 2 Diabetes

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

prolonged SB

SB broken 1

SB broken 2

Study Details

Brief summary:

Type 2 diabetes (T2D) confers a high risk of cardiovascular disease (CVD), particularly among older adults who tend to be physically inactive. Prolonged sedentary behavior (SB) has been shown to negatively influence markers of cardiovascular risk (e.g., blood glucose, blood pressure), even among individuals who are physically active. Most studies that have examined the effects of breaking up SB have focused on young healthy males and prioritized glycemic outcomes. Additionally, sex differences in these outcomes have not been adequately examined. The present study will address these gaps. This 3-arm crossover randomized controlled trial will compare the effects of 3 SB conditions on markers of vascular function. The 3 conditions are: 1) 4 hours of prolonged SB, 2) 4 hours of SB broken up by 5 minutes of self-paced walking every hour, and 3) 4 hours of SB with one 20-minute bout of self-paced walking. In addition to examining the overall effects of each condition, sex differences in physiological responses will be evaluated.

Conditions

Type 2 Diabetes

Cardiovascular Diseases

Study ID

NCT05838586

Start date

Jul 31, 2023

Status verified date

Aug, 2024

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥60 years
  • Postmenopausal (females only, ≥12 months without a menstrual period)
  • Type 2 diabetes (hemoglobin A1c ≥6.5% and/or previous diagnosis of type 2 diabetes)
  • ≥6 hours/day sedentary (assessed via IPAQ)
  • Willingness to abstain from food, caffeine, alcohol and exercise for >= 24 hours, and tobacco/smoking for ≥12 hours prior to each intervention visit
  • Ability to speak and read English

Exclusion Criteria:

  • Type 1 diabetes
  • Uncontrolled hypertension (resting systolic ≥160 or diastolic ≥110 mmHg)
  • Initiation of hormone therapy or change in hormone therapy dose/frequency/route of administration in the previous 3 months
  • Renal dialysis
  • History of deep vein thrombosis (DVT)
  • Evidence of cognitive impairment that could impact ability to consent and/or participation (Mini-Cog score <3)
  • Achieving physical activity guidelines (≥150 minutes of MVPA/week, assessed via IPAQ))
  • Physical impairment or disability that interferes with ability to engage in PA (e.g., severe osteoarthritis, lower extremity amputation \[other than toe(s)/partial foot\], use of a walker or wheelchair, etc.),
  • Unstable medical/psychiatric condition that could impact study participation

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: CON

Control group

experimental: Break

experimental: BOUT

Interventions

prolonged SB

4 hours of prolonged SB

SB broken 1

4 hours of SB broken up by 5 minutes of self-paced walking every hour

SB broken 2

4 hours of SB with one 20-minute bout of self-paced walking

Primary outcome measure

  • iAUC of SBP [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Mary O Whipple, PhD, RN, PHN

612-625-4470whipp042@umn.edu

study coordinator

6126265823sittingresearch@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Mary O Whipple, PhD, RN, PHN

612-625-4470whipp042@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Aug 2, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by University of Minnesota on 2024-08-02.