NCT07847684

Brief Summary

This study will examine whether very short bouts of stair climbing performed throughout the day can improve blood sugar control and cardiovascular health in adults with prediabetes. Participants will complete three separate study visits in random order: uninterrupted sitting, sitting interrupted by 3-minute light walking breaks each hour, and sitting interrupted by brief stair-climbing exercise "snacks" each hour. During each visit, the research team will measure glucose, insulin, blood lipids, markers of inflammation and oxidative stress, and blood-vessel function. Continuous glucose monitors, blood samples, heart-rate and blood-pressure measurements, vascular ultrasound, and questionnaires will be used to assess the participants' responses. The goal of the study is to determine whether brief stair-climbing breaks may be a practical way to reduce the negative effects of prolonged sitting and improve metabolic health in adults with prediabetes.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Jul 2027

First Submitted

Initial submission to the registry

September 16, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

9 months

First QC Date

September 16, 2026

Last Update Submit

September 23, 2026

Conditions

Keywords

Stair ClimbingExercise SnacksSedentary BehaviorPostprandial GlucoseInsulin ResistanceVascular FunctionContinuous Glucose MonitoringPostprandial InsulinOxidative StressInflammation

Outcome Measures

Primary Outcomes (2)

  • 6-Hour Postprandial Glucose Area Under the Curve (AUC)

    Plasma glucose will be measured from a fasting venous blood sample obtained before Meal 1 and from serial venous blood samples collected every 30 minutes through 360 minutes after Meal 1 completion. Meal 1 completion will define the start of the postprandial period, and a second standardized meal will be provided at approximately 180 minutes. Plasma glucose AUC will be calculated across the 6-hour experimental period and compared among uninterrupted sitting, hourly 3-minute light walking breaks, and hourly stair-climbing exercise snacks.

    From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion

  • 6-Hour Postprandial Plasma Insulin Area Under the Curve (AUC)

    Plasma insulin will be measured from a fasting venous blood sample obtained before Meal 1 and from prespecified serial venous blood samples collected through 360 minutes after Meal 1 completion. Meal 1 completion will define time 0, and a second standardized meal will be provided at approximately 180 minutes. Insulin AUC will be calculated across the 0- to 360-minute experimental period and compared among uninterrupted sitting, hourly 3-minute light walking breaks, and hourly stair-climbing exercise snacks.

    From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion

Secondary Outcomes (11)

  • 6-Hour Postprandial Plasma Free Fatty Acid Response

    From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion

  • 6-Hour Postprandial Plasma Triglyceride Response

    From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion

  • Postprandial Plasma Malondialdehyde (MDA)

    From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion

  • Postprandial Plasma Inflammatory Cytokines (TNF-α and IL-6)

    From fasting baseline before Meal 1 through 360 minutes after Meal 1 completion

  • Change in Superficial Femoral Artery Diameter

    Baseline before Meal 1 and at the end of the 6-hour experimental period, approximately 360 minutes after Meal 1 completion

  • +6 more secondary outcomes

Study Arms (3)

Uninterrupted Sitting

NO INTERVENTION

Participants will remain seated throughout the approximately 6-hour experimental visit, except as needed for study procedures. At the time points corresponding to activity bouts in the walking and stair-climbing conditions, participants will remain seated. This condition serves as the sedentary control condition.

Hourly 3-Minute Light Walking Breaks

ACTIVE COMPARATOR

Participants will interrupt prolonged sitting with a 3-minute light walking break at approximately 30, 90, 150, 210, 270, and 330 minutes during the approximately 6-hour experimental visit. Walking breaks will therefore occur at 60-minute intervals.

Behavioral: Hourly 3-Minute Light Walking Breaks

Hourly Stair-Climbing Exercise Snacks

EXPERIMENTAL

Participants will interrupt prolonged sitting with brief stair-climbing exercise snacks at approximately 30, 90, 150, 210, 270, and 330 minutes during the approximately 6-hour experimental visit. During each bout, participants will ascend approximately three flights of stairs at a fast but safe self-selected pace for about 20 seconds.

Behavioral: Hourly Stair-Climbing Exercise Snacks

Interventions

Participants will interrupt prolonged sitting with a 3-minute light walking break at approximately 30, 90, 150, 210, 270, and 330 minutes during the approximately 6-hour experimental visit. Activity breaks are therefore separated by approximately 60 minutes. Participants will otherwise remain seated except as required for study procedures.

Hourly 3-Minute Light Walking Breaks

Participants will interrupt prolonged sitting with brief stair-climbing exercise snacks at approximately 30, 90, 150, 210, 270, and 330 minutes during the approximately 6-hour experimental visit. During each bout, participants will ascend approximately three flights of stairs at a fast but safe self-selected pace for about 20 seconds. Participants will not run or skip steps, and use of the handrail will be permitted as needed.

Hourly Stair-Climbing Exercise Snacks

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 69 years, inclusive. Body mass index (BMI) 25.0 to 40.0 kg/m², inclusive.
  • Objectively confirmed prediabetes based on at least one of the following:
  • HbA1c 5.7% to 6.4%;
  • fasting plasma glucose 100 to 125 mg/dL; or
  • hour plasma glucose 140 to 199 mg/dL during a 75-g oral glucose tolerance test.
  • Able to understand study procedures and provide written informed consent in English.
  • Able to safely perform repeated walking and vigorous stair-climbing activity based on medical history, resting vital signs, PAR-Q+ responses, investigator assessment, and medical clearance when required.
  • Able to safely undergo repeated venous blood collection and IV-catheter placement.
  • Able to safely consume the standardized study meals. Willing and able to complete all three experimental conditions and comply with fasting, dietary, physical-activity, medication, and pre-visit standardization instructions.

You may not qualify if:

  • BMI below 25.0 kg/m² or above 40.0 kg/m². Diagnosed type 1 or type 2 diabetes mellitus. Laboratory findings that do not confirm prediabetes or that suggest diabetes, including HbA1c ≥6.5%, fasting plasma glucose ≥126 mg/dL, or 2-hour plasma glucose ≥200 mg/dL during a 75-g oral glucose tolerance test.
  • Cardiovascular, pulmonary, musculoskeletal, neurological, or other medical conditions that would preclude safe participation in the walking or stair-climbing interventions.
  • Resting vital signs, current symptoms, or other screening findings indicating that exercise participation would be unsafe.
  • Pregnancy, plans to become pregnant during the study period, or breastfeeding. Current use of medications that may substantially affect glucose metabolism, lipid metabolism, body weight, study outcomes, or safe participation, including insulin, glucose-lowering medications, GLP-1 receptor agonists, pharmacologic weight-loss medications, systemic corticosteroids, or other medications judged by the investigator to interfere with study outcomes or safety.
  • Contraindications to vascular ultrasound, repeated blood collection, IV-catheter placement, or exercise participation.
  • Food allergies, intolerances, or dietary restrictions that prevent safe consumption of the standardized study meals.
  • Known allergy or severe skin sensitivity to adhesives used with continuous glucose monitors.
  • Bleeding disorder, current anticoagulant use, history of anemia, recent blood donation, recurrent fainting during blood collection, difficult venous access, or another condition judged to create unacceptable risk from repeated blood sampling or IV-catheter placement.
  • Inability to safely perform repeated walking or stair climbing. PAR-Q+ result requiring further medical evaluation when the participant does not obtain required written medical clearance.
  • Any other condition or finding that, in the judgment of the Principal Investigator or qualified study investigator, would make participation unsafe or substantially interfere with completion of study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63104, United States

RECRUITING

Related Publications (6)

  • Fujie S, Rafiei H, Kanemoto M, Konishi S, Iemitsu M, Little JP. Effect of prolonged sitting with stair climbing exercise "snacks" on circulating myokines profiles. Eur J Appl Physiol. 2026 Jul;126(7):4127-4135. doi: 10.1007/s00421-026-06229-2. Epub 2026 Apr 10.

    PMID: 41961282BACKGROUND
  • Moore J, Salmons H, Vinoskey C, Kressler J. A single one-minute, comfortable paced, stair-climbing bout reduces postprandial glucose following a mixed meal. Nutr Metab Cardiovasc Dis. 2020 Oct 30;30(11):1967-1972. doi: 10.1016/j.numecd.2020.06.020. Epub 2020 Jun 29.

    PMID: 32811738BACKGROUND
  • Dunstan DW, Kingwell BA, Larsen R, Healy GN, Cerin E, Hamilton MT, Shaw JE, Bertovic DA, Zimmet PZ, Salmon J, Owen N. Breaking up prolonged sitting reduces postprandial glucose and insulin responses. Diabetes Care. 2012 May;35(5):976-83. doi: 10.2337/dc11-1931. Epub 2012 Feb 28.

    PMID: 22374636BACKGROUND
  • Gay JL, Buchner DM, Erickson ML, Lauture A. Effect of short bouts of high intensity activity on glucose among adults with prediabetes: A pilot randomized crossover study. Diabetes Res Clin Pract. 2018 Jul;141:168-174. doi: 10.1016/j.diabres.2018.04.045. Epub 2018 May 7.

    PMID: 29746878BACKGROUND
  • Caldwell HG, Coombs GB, Rafiei H, Ainslie PN, Little JP. Hourly staircase sprinting exercise "snacks" improve femoral artery shear patterns but not flow-mediated dilation or cerebrovascular regulation: a pilot study. Appl Physiol Nutr Metab. 2021 May;46(5):521-529. doi: 10.1139/apnm-2020-0562. Epub 2020 Nov 26.

    PMID: 33242251BACKGROUND
  • Rafiei H, Omidian K, Myette-Cote E, Little JP. Metabolic Effect of Breaking Up Prolonged Sitting with Stair Climbing Exercise Snacks. Med Sci Sports Exerc. 2021 Jan;53(1):150-158. doi: 10.1249/MSS.0000000000002431.

    PMID: 32555024BACKGROUND

MeSH Terms

Conditions

Prediabetic StateSedentary BehaviorInsulin ResistanceInflammation

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehaviorHyperinsulinismPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hossein Rafiei, PhD, RD, ACSM-CPT

    St. Louis University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hossein Rafiei, PhD, RD, ACSM-CPT

CONTACT

Oluwatoyosi Owoeye, BPT, M.S., Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized, counterbalanced, three-condition crossover study. Each participant will complete uninterrupted sitting, hourly 3-minute light walking breaks, and hourly brief stair-climbing exercise snacks in randomized order, with a washout period of at least 7 days between experimental visits.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 16, 2026

First Posted

September 29, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in the primary publication may be shared upon reasonable request to the Principal Investigator, subject to institutional policies, applicable ethical and privacy requirements, and execution of an appropriate data-use agreement when required.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 6 months after publication of the primary study results and continuing for 5 years.
Access Criteria
De-identified individual participant data underlying the published results and selected supporting materials may be made available to qualified researchers upon reasonable request to the Principal Investigator. Requests should include a scientifically sound proposal describing the planned analyses and intended use of the data. Access will be subject to applicable Saint Louis University policies, ethical and privacy requirements, and execution of a data-use agreement when required. Data will not include direct participant identifiers.

Locations