- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07849439
Two-Week Stair-Climbing Exercise Snacks and Metabolic Health in Adults With Overweight or Obesity: A Pilot Study
Effects of a Two-Week Stair-Climbing "Exercise Snacks" Intervention on Body Composition, Cardiovascular Fitness, and Metabolic Responses in Overweight and Obese Adults: A Pilot Study
This pilot study will evaluate whether brief bouts of stair climbing performed throughout the day for two weeks can improve metabolic health, cardiovascular fitness, and other health-related outcomes in adults with overweight or obesity who do not regularly exercise. Participants will complete approximately 6-8 brief stair-climbing "exercise snacks" per day for 14 days, with each bout consisting of approximately 60 total stair steps performed at a challenging but safe self-selected pace.
Participants will complete baseline and post-intervention assessments at Saint Louis University. These assessments will include continuous glucose monitoring and standardized meal testing to evaluate glucose responses, as well as measures of aerobic fitness, anaerobic power, body composition, waist circumference, and muscular strength. The study will also evaluate adherence, perceived exercise intensity, and the feasibility of incorporating brief stair-climbing bouts into daily life.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This is a pilot intervention study designed to examine the short-term effects and feasibility of frequent stair-climbing "exercise snacks" in adults with overweight or obesity. Exercise snacks are brief bouts of physical activity performed intermittently throughout the day and may provide a time-efficient approach to increasing physical activity.
The study will enroll approximately 12 adults aged 18-35 years with a body mass index of 25.0-34.9 kg/m² who are otherwise healthy and do not regularly participate in structured exercise. Participants must have regular access to a safe staircase.
Participants will complete three in-person study visits at Saint Louis University over approximately 15-16 days. Baseline assessments will include anthropometric and body composition measurements, resting cardiovascular measures, handgrip strength, aerobic fitness testing, and anaerobic power testing. Participants will also complete a standardized meal challenge while wearing a continuous glucose monitor to assess postprandial glucose responses.
Following baseline testing, participants will complete a two-week stair-climbing intervention. They will perform approximately 6-8 stair-climbing bouts per day for approximately 14 days. Each bout will consist of approximately 60 total stair steps completed at a self-selected challenging but safe pace. Participants may use one or more flights of stairs repeatedly if approximately 60 continuous upward steps are not available. The intervention will be completed in participants' usual daily environments, such as home, work, or campus.
Participants will wear a continuous glucose monitor during the intervention period and will complete activity, dietary, and study-related logs. After the two-week intervention, participants will repeat the standardized meal challenge and laboratory assessments.
The primary study outcomes include changes in postprandial glucose response, glycemic variability, and aerobic fitness from baseline to post-intervention. Secondary outcomes include changes in body composition, waist circumference, anaerobic power, and muscular strength. Exploratory outcomes include adherence and feasibility of the stair-climbing intervention.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Hossein Rafiei, PhD, RD
- Telefonnummer: 314-977-8675
- E-Mail: hossein.rafiei@health.slu.edu
Studienorte
-
-
Missouri
-
St Louis, Missouri, Vereinigte Staaten, 63104
- Rekrutierung
- Saint Louis University
-
Kontakt:
- Hossein Rafiei, PhD RD
- Telefonnummer: 314-977-8675
- E-Mail: hossein.rafiei@health.slu.edu
-
Hauptermittler:
- Hossein Rafiei, PhD, RD
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Age 18-35 years and able to provide informed consent.
- Body mass index (BMI) 25.0-34.99 kg/m² and otherwise healthy, without chronic disease.
- Sedentary or low-active lifestyle, defined as no regular structured exercise ≥3 days/week for ≥30 minutes per session during the past 3 months.
- Access to a safe staircase that permits completion of approximately 60 total stair steps per exercise bout. Approximately 60 upward steps are preferred when available; one or more flights may be used repeatedly if needed.
- No contraindications or increased-risk findings identified on the PAR-Q+ or health history screening.
Exclusion Criteria:
- Known cardiovascular, pulmonary, metabolic, renal, neurological, or musculoskeletal disease, or signs or symptoms suggesting increased risk during vigorous exercise, including diagnosed diabetes mellitus, cardiovascular disease, uncontrolled hypertension, chronic pulmonary disease, kidney disease, fainting or unexplained dizziness during exercise, chest pain with exertion, or severe shortness of breath with mild-to-moderate activity.
- Current use of medications that may affect exercise tolerance, heart-rate response, balance, glucose metabolism, or safety during vigorous exercise, including insulin or other glucose-lowering medications, beta-blockers, anti-arrhythmic medications, systemic corticosteroids, or medications that may cause dizziness, impaired balance, or altered exercise response.
- Orthopedic or joint conditions that could be aggravated by repeated stair climbing.
- Allergy, intolerance, dietary restriction, or other condition preventing safe consumption of the standardized meal replacement shake.
- Pregnancy or plans to become pregnant during the study period.
- Any other medical or psychological condition that, in the investigator's judgment, could make adherence difficult or place the participant at risk.
- Individuals currently enrolled in a course taught by the PI or other study personnel, or who are directly supervised, graded, or formally evaluated by a member of the study team.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Two-Week Stair-Climbing Exercise Snacks
Participants will complete a two-week stair-climbing exercise snack intervention. They will perform approximately 6-8 brief stair-climbing bouts per day for approximately 14 days. Each bout will include approximately 60 total stair steps completed at a self-selected challenging but safe pace. Participants will otherwise be asked to maintain their usual diet and lifestyle and avoid beginning a new exercise or diet program during the study. |
Participants will perform brief stair-climbing exercise snacks 6-8 times per day for 14 days. Each bout will consist of approximately 60 total stair steps completed at a self-selected challenging but safe pace. When possible, participants will complete approximately 60 upward steps. If 60 continuous upward steps are not available, participants may use one or more flights repeatedly by ascending and descending carefully until approximately 60 total steps are completed. The intervention will be completed independently in participants' usual daily environments, such as home, work, or campus. Participants will be instructed to use the handrail when needed, descend slowly and carefully, and not run down the stairs. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in 2-Hour Postprandial Glucose Area Under the Curve (AUC)
Zeitfenster: Baseline (Day 1) and post-intervention (Day 15)
|
Postprandial glucose response will be assessed using continuous glucose monitoring during a standardized meal challenge performed before and after the two-week stair-climbing intervention. Glucose area under the curve (AUC) over the approximately 2-hour post-meal period will be calculated using the trapezoidal method and compared between pre- and post-intervention assessments. |
Baseline (Day 1) and post-intervention (Day 15)
|
|
Change in CGM-Derived Glucose Standard Deviation
Zeitfenster: Early intervention (Days 2-4) and late intervention (Days 11-13)
|
Glucose standard deviation will be calculated from continuous glucose monitoring data over three complete 24-hour periods during the early and late intervention periods and compared within participants. |
Early intervention (Days 2-4) and late intervention (Days 11-13)
|
|
Change in Aerobic Capacity (VO₂max or Estimated VO₂max)
Zeitfenster: Baseline (Day 0) and post-intervention (Day 15)
|
Aerobic capacity will be assessed using a VO₂max or estimated VO₂max test with metabolic cart analysis/indirect calorimetry during a graded exercise test. Peak oxygen uptake will be expressed in mL/kg/min and compared between baseline and post-intervention assessments. If a maximal test is not appropriate or feasible, a submaximal test with VO₂ extrapolation may be used. |
Baseline (Day 0) and post-intervention (Day 15)
|
|
Change in CGM-Derived Glucose Coefficient of Variation
Zeitfenster: Early intervention (Days 2-4) and late intervention (Days 11-13)
|
Glucose coefficient of variation will be calculated from continuous glucose monitoring data over three complete 24-hour periods during the early and late intervention periods and compared within participants. |
Early intervention (Days 2-4) and late intervention (Days 11-13)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Body Weight
Zeitfenster: Baseline (Day 0) and post-intervention (Day 15)
|
Body weight will be measured using the InBody 380 bioelectrical impedance analysis (BIA) system and compared between baseline and post-intervention assessments. |
Baseline (Day 0) and post-intervention (Day 15)
|
|
Change in Body Fat Percentage
Zeitfenster: Baseline (Day 0) and post-intervention (Day 15)
|
Total body fat percentage will be assessed using the InBody 380 bioelectrical impedance analysis (BIA) system and compared between baseline and post-intervention assessments. |
Baseline (Day 0) and post-intervention (Day 15)
|
|
Change in Fat Mass
Zeitfenster: Baseline (Day 0) and post-intervention (Day 15)
|
Total body fat mass will be assessed using the InBody 380 bioelectrical impedance analysis (BIA) system and compared between baseline and post-intervention assessments. |
Baseline (Day 0) and post-intervention (Day 15)
|
|
Change in Lean Mass
Zeitfenster: Baseline (Day 0) and post-intervention (Day 15)
|
Total lean mass will be assessed using the InBody 380 bioelectrical impedance analysis (BIA) system and compared between baseline and post-intervention assessments. |
Baseline (Day 0) and post-intervention (Day 15)
|
|
Change in Phase Angle
Zeitfenster: Baseline (Day 0) and post-intervention (Day 15)
|
Phase angle will be assessed using the InBody 380 bioelectrical impedance analysis (BIA) system and compared between baseline and post-intervention assessments. |
Baseline (Day 0) and post-intervention (Day 15)
|
|
Change in Waist Circumference
Zeitfenster: Baseline (Day 0) and post-intervention (Day 15)
|
Waist circumference will be measured using a measuring tape at the iliac crest and compared between baseline and post-intervention assessments. |
Baseline (Day 0) and post-intervention (Day 15)
|
|
Change in Wingate Peak Power
Zeitfenster: Baseline (Day 0) and post-intervention (Day 15)
|
Peak anaerobic power will be assessed during a 30-second Wingate anaerobic test performed on a cycle ergometer and compared between baseline and post-intervention assessments. |
Baseline (Day 0) and post-intervention (Day 15)
|
|
Change in Wingate Mean Power
Zeitfenster: Baseline (Day 0) and post-intervention (Day 15)
|
Mean anaerobic power will be assessed during a 30-second Wingate anaerobic test performed on a cycle ergometer and compared between baseline and post-intervention assessments. |
Baseline (Day 0) and post-intervention (Day 15)
|
|
Change in Handgrip Strength
Zeitfenster: Baseline (Day 0) and post-intervention (Day 15)
|
Handgrip strength will be measured using an InBody handgrip dynamometer. The best of three trials for each hand will be recorded, with dominant-hand grip strength used for the primary comparison between baseline and post-intervention assessments. |
Baseline (Day 0) and post-intervention (Day 15)
|
|
Change in Segmental Body Fat Percentage
Zeitfenster: Baseline (Day 0) and post-intervention (Day 15)
|
Segmental body fat percentage will be assessed using the InBody 380 bioelectrical impedance analysis (BIA) system and compared between baseline and post-intervention assessments. |
Baseline (Day 0) and post-intervention (Day 15)
|
|
Change in 24-Hour Mean Glucose
Zeitfenster: Early intervention (Days 2-4) and late intervention (Days 11-13)
|
Mean glucose will be calculated from continuous glucose monitoring data over prespecified early- and late-intervention periods and compared within participants. |
Early intervention (Days 2-4) and late intervention (Days 11-13)
|
|
Change in Time in Range
Zeitfenster: Early intervention (Days 2-4) and late intervention (Days 11-13)
|
The percentage of CGM readings within the prespecified glucose target range will be calculated over early- and late-intervention periods and compared within participants. |
Early intervention (Days 2-4) and late intervention (Days 11-13)
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Hossein Rafiei, PhD, RD, St. Louis University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- STUDY00000657
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Individual participant data will not be shared with researchers outside the study team, in accordance with the IRB-approved protocol and informed consent. Study findings may be disseminated in aggregate form through scientific presentations and peer-reviewed publications.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .