NCT04142346

Brief Summary

Regularly interrupting sedentary behavior (SB) with activity breaks may attenuate postprandial glucose (PPG) excursions and improve glycemic control. The investigators aimed to determine the effect of interrupting 7 hours of prolonged sitting with brief bouts of moderate physical activity (PA) (alternating between up/down stairs and sit/stand up from the chair) on postprandial glucose (PPG) responses in comparison with uninterrupted sitting. In addition, the investigators aimed to examine the effects of 2 weeks of detraining (DT) on PPG on both protocols. Non-diabetic, trained older adults (n = 15) will be recruited for a randomized crossover trial with two treatments performed in two different training conditions: 1) uninterrupted sitting protocol (CON); 2) seated with 2-minutes bouts of moderate PA every 30 minutes (INT). Both protocols will be performed in a trained condition and after 2 weeks of DT. In the early morning of each trial, participants will do an oral glucose tolerance test (OGTT) and 2 blood samples will be collected (fasting and after 2 hours); 2.5 hours after, participants will begin the protocol and two standardized meals will be provided (0 hours and at 3 hours). An iPro2 continuous glucose monitoring (CGM) system will record the average interstitial glucose concentration every 5 minutes. Positive incremental area under the curve (iAUC) and total area under the curve (pAUC) for glucose as well as mean glucose (MG) will be calculated using Matlab. Differences between both protocols and between the two different moments will be examined using generalized estimation equation (GEE), adjusting for sex and age (CI 95%).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

5 months

First QC Date

October 21, 2019

Last Update Submit

October 28, 2019

Conditions

Keywords

sitting timephysical inactivitybreaksglycemic controlcontinuous glucose monitoringolder adults

Outcome Measures

Primary Outcomes (1)

  • Continuous glucose monitoring before and after 2-Weeks of detraining for each intervention protocol (prolonged sitting vs. breaking-up sitting)

    Immediately upon arrival at the laboratory and throughout 24h, a blood glucose monitor (iPro2 CGM with Enlite Sensors MiniMed; Medtronic, Northridge, California, USA) will be placed on the right side of the abdomen. Once inserted, CGM provides interstitial glucose values every 5 minutes. To calibrate the CGM, four capillary blood glucose samples (three in the laboratory and one at home) will be collected and measured using a glucometer (Contour Next One, Ascensia Diabetes Care, Basel, Switzerland).

    1-month (2 measurement times, one for each protocol, including baseline and after detraining)

Secondary Outcomes (12)

  • Postural allocation

    1-month (2 measurement times, one for each protocol, including baseline and after detraining)

  • Body Composition

    1-month (2 measurement times (one at baseline and after two weeks of detraining))

  • Weight

    1-month (2 measurement times (one at baseline and after two weeks of detraining))

  • Height

    1-month (2 measurement times (one at baseline and after two weeks of detraining))

  • Cardiorespiratory fitness (CRF)

    1-month (2 measurement times (one at baseline and after two weeks of detraining))

  • +7 more secondary outcomes

Study Arms (2)

Uninterrupted sitting

NO INTERVENTION

Participants remained seated throughout 7 hours. During the protocol, participants were allowed to go to the bathroom in a wheelchair and al-libitum water was granted.

Sitting + moderate intensity breaks

EXPERIMENTAL

Participants were instructed to sit throughout 7 hours, while interrupting the sitting position every 30 minutes to perform 2 minutes of moderate-intensity physical activity. The breaks consisted of walk up and down stairs and squats. Each person performed these exercise alternately. During the protocol, participants were allowed to go to the bathroom in a wheelchair and al-libitum water was granted.

Behavioral: Sitting + moderate intensity breaks

Interventions

Participants will be followed in a randomized crossover trial undertaken at Faculty of Human Kinetics between April and August 2019. Participants will attend to the laboratory on twelve separate occasions: visit 1 (day 1), baseline assessments for body composition; visit 2 (day 2), cardiorespiratory fitness assessment; visit 3 (day 3), OGTT and the first randomized experimental protocol; visit 4 (day 4), follow-up OGTT; visit 5 (4-6 days after the first experimental protocol), OGTT and the remaining experimental protocol; visit 6 (day following the previous experimental protocol), follow-up OGTT. An additional 6 visits will be performed following the same rational, after a 2-week period of detraining, where participants will be instructed to refrain from structured exercise. The follow-up assessments for body composition and cardiorespiratory fitness will be accomplished after the protocols.

Sitting + moderate intensity breaks

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Men or women
  • and 90 years-old
  • Physically active
  • Engaged in structured exercise at least twice a week for the past 6 months.

You may not qualify if:

  • Diagnosed with diabetes
  • Any type of physical limitation that would prevent them from practicing exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Human Kinetics, University of Lisbon

Cruz Quebrada, Portugal

Location

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Sitting Position

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Luis Sardinha, PhD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 21, 2019

First Posted

October 29, 2019

Study Start

April 1, 2019

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

October 30, 2019

Record last verified: 2019-10

Locations