- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07765485
Effect of Pyramidal Aerobic Training on Ventilatory Function in Cigarette Smokers
13. august 2026 opdateret af: Tarek Taha Fathy, Cairo University
Statement of the problem:
Does the pyramidal aerobic training affect ventilatory function parameters in smokers?
Null hypothesis:
Pyramidal aerobic training has no significant effect on ventilatory function parameters (such as Forced Vital Capacity [FVC], Forced Expiratory Volume in one second [FEV₁], and Peak Expiratory Flow Rate [PEFR]) in adult smokers.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
This randomized controlled trial evaluates the effect of an eight-week pyramidal aerobic training program on ventilatory function in cigarette smokers.
Forty male cigarette smokers aged 18 to 28 years will be randomly allocated to either a pyramidal aerobic training group or a control group.
The intervention group will perform treadmill-based pyramidal aerobic training three times per week for eight consecutive weeks.
Each session will include a warm-up, pyramidal aerobic training with ascending and descending intensity levels, and a cool-down.
Training intensity will range from 20% to 80% of the participant's target heart rate calculated using the Karvonen formula.
Ventilatory function will be assessed by spirometry, while functional capacity, health-related quality of life, and smoking abstinence self-efficacy will also be assessed at baseline and after the intervention.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
40
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
October City
-
Giza, October City, Egypten
- Faculty of Physical Therapy, Ahram Canadian University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Cigarette smoker males aged from 18 to 28 years.
- Smoking index = 50.
- Sedentary lifestyle.
- BMI between 18.5 and 29.9 kg/m².
- Cigarette smokers demonstrate mild to moderate impairment in ventilatory function confirmed by baseline spirometry.
- SASEQ (Smoking Abstinence Self-Efficacy Questionnaire) moderate self-efficacy, score from 9 to 16.
- Cigarette smokers are able and willing to participate in aerobic training sessions
Exclusion Criteria:
- Patients diagnosed with chronic respiratory diseases such as asthma.
- Patients with cardiovascular diseases or other systemic illnesses that contraindicate exercise.
- Patients who experienced recent respiratory infections within the last 4 weeks.
- Patients currently engaged in regular structured aerobic or respiratory training programs.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Pyramidal Aerobic Training Group
Participants will receive pyramidal aerobic training on a treadmill three times per week for eight consecutive weeks.
|
Pyramidal aerobic training performed on a motorized treadmill three times per week for eight consecutive weeks.
Each session consists of 5 minutes of warm-up, 20 minutes of pyramidal aerobic training with 5 ascending and 5 descending intensity levels, each lasting 2 minutes, followed by 5 minutes of cool-down.
Training intensity ranges from 20% to 80% of the participant's target heart rate calculated using the Karvonen formula, with heart rate monitored using a pulse oximeter.
|
|
Ingen indgriben: Control Group
Participants will be assigned to the control group.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1)
Tidsramme: Baseline and after 8 weeks of intervention
|
Baseline and after 8 weeks of intervention
|
|
Forced Vital Capacity (FVC)
Tidsramme: Baseline and after 8 weeks of intervention
|
Baseline and after 8 weeks of intervention
|
|
FEV1/FVC Ratio
Tidsramme: Baseline and after 8 weeks of intervention
|
Baseline and after 8 weeks of intervention
|
|
Peak Expiratory Flow Rate (PEFR)
Tidsramme: Baseline and after 8 weeks of intervention
|
Baseline and after 8 weeks of intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional Capacity (VO2max)
Tidsramme: Baseline and after 8 weeks of intervention
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Baseline and after 8 weeks of intervention
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|
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Health-Related Quality of Life (SF-12)
Tidsramme: Baseline and after 8 weeks of intervention
|
Baseline and after 8 weeks of intervention
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Smoking Abstinence Self-Efficacy Questionnaire (SASEQ) Score
Tidsramme: Baseline and after 8 weeks of intervention
|
Smoking abstinence self-efficacy will be assessed using the Smoking Abstinence Self-Efficacy Questionnaire (SASEQ).
The questionnaire score ranges from 9 to 16, with higher scores indicating greater smoking abstinence self-efficacy.
|
Baseline and after 8 weeks of intervention
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Tarek Taha Fathy, Cairo University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
6. september 2025
Primær færdiggørelse (Faktiske)
10. februar 2026
Studieafslutning (Faktiske)
15. april 2026
Datoer for studieregistrering
Først indsendt
10. august 2026
Først indsendt, der opfyldte QC-kriterier
13. august 2026
Først opslået (Faktiske)
14. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P.T.REC/012/006336
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