Clinical trial NCT04142346: Breaking-up Sedentary Time and 2 Weeks Detraining
Official title: Postprandial Glucose Responses in Trained Older Adults: Effects of Breaking-up Sedentary Time and 2 Weeks Detraining
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Old Age
Keywords: sitting time
physical inactivity
breaks
glycemic control
continuous glucose monitoring
older adults
Lead sponsor: University of Lisbon
Sponsor class: OTHER
Collaborators: name: Associação Protectora dos Diabéticos de Portugal
First posted: 2019-10-29
Enrollment: 14
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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%).

Detailed description: Participants will be recruited to take part in a randomized crossover trial using media advertisements and group events within the Lisbon Metropolitan Area. In order to be part of this intervention, the participants will have to be men or women aged between 65 and 90 years-old, physically active, and engaged in structured exercise at least twice a week for the past 6 months. People who have diabetes or any type of physical limitation that would prevent them from performing exercise will be excluded. Power and sample size calculations (G-Power 3.1.9.2) were based on an effect size of 0.78 for the glucose iAUC, a power of 0.80, and a significance of 0.05. The calculation yielded a sample size of 15 participants. This study was approved by the Ethics Committee of the Faculty of Human Kinetics (approval number: 06/2019) and conducted in accordance with the Declaration of Helsinki and with the Convention on Human Rights and Biomedicine. Written informed consents were obtained from all participants.

Participants will be followed in a randomized crossover trial undertaken at Faculty of Human Kinetics between April and August 2019. Participants will attend 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 and reduce their physical activity. The follow-up assessments for body composition and cardiorespiratory fitness will be accomplished after the protocols. Experimental protocol order will be randomized at baseline and on the follow-up period after the detraining process by a third party using a computer-generated list of random numbers (block randomization with balanced block sizes).

On the morning of each intervention day, participants will arrive at the laboratory at 8:00 a.m., after a 10h fast. For 48h prior to intervention day, participants will be asked to refrain from structured moderate-to-vigorous physical activity (MVPA), caffeine and alcohol consumption. Each intervention day will have a total duration of 9.5h and will start with an oral glucose tolerance test. After a baseline blood collection, participants will be instructed to drink an oral glucose drink of 75g dissolved in water (200 ml). Two hours after, another blood sample will be drawn.

At 10:30 a.m., a mixed standard meal (breakfast) will be given to the participants, marking the begging of the 7 hour protocol. The same standard meal will be provided at 1:30 p.m. (lunch). The 200-ml meal will consist of 303 kcal, 42g carbohydrate, 10g fat and 11.2g protein, vitamins and minerals (Nestle Health Science - Resource Energy). The participants will be encouraged to consume the entire meal within 5 minutes. The protocols performed will be: 1) uninterrupted sitting: participants will remain seated throughout 7 hours (SIT); 2) Sitting + moderate intensity breaks: participants will be 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 will consist of walk up and down the stairs and squats. Each person will perform these exercises alternately. During the protocol, participants will be allowed to go to the bathroom in a wheelchair and al-libitum water will be granted. The following morning after the protocol, the OGTT will be repeated.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Continuous glucose monitoring before and after 2-Weeks of detraining for each intervention protocol (prolonged sitting vs. breaking-up sitting)
timeFrame: 1-month (2 measurement times, one for each protocol, including baseline and after detraining)
Secondary outcomes:
measure: Postural allocation
timeFrame: 1-month (2 measurement times, one for each protocol, including baseline and after detraining)
measure: Body Composition
timeFrame: 1-month (2 measurement times (one at baseline and after two weeks of detraining))
measure: Weight
timeFrame: 1-month (2 measurement times (one at baseline and after two weeks of detraining))
measure: Height
timeFrame: 1-month (2 measurement times (one at baseline and after two weeks of detraining))
measure: Cardiorespiratory fitness (CRF)
timeFrame: 1-month (2 measurement times (one at baseline and after two weeks of detraining))
measure: Objective Measures of Physical Activity
timeFrame: 1-month (2 measurement times (one week at baseline and during the two weeks of detraining))
measure: Objective Measures of Sedentary Time
timeFrame: 1-month (2 measurement times (one week at baseline and during the two weeks of detraining))
measure: Upper limb muscle strength
timeFrame: 1-month (2 measurement times (one at baseline and after two weeks of detraining))
measure: Lower limb muscle strength
timeFrame: 1-month (2 measurement times (one at baseline and after two weeks of detraining))
measure: Phase angle (PhA)
timeFrame: 1-month (2 measurement times (one at baseline and after two weeks of detraining))
measure: Body Water
timeFrame: 1-month (2 measurement times (one at baseline and after two weeks of detraining))
measure: Oral Glucose Tolerance Test
timeFrame: 1-month (4 measurement times, two for each protocol (in the morning of each protocol day and the day after), including baseline and after detraining)
Other outcomes:
Locations:
city: Cruz Quebrada
country: Portugal
facility: Faculty of Human Kinetics, University of Lisbon
Study officials:
affiliation: Professor
name: Luis Sardinha, PhD
role: PRINCIPAL_INVESTIGATOR
References: