- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07825623
The Effect of a Structured Workplace Exercise Program on 360-Degree Performance Evaluation, Job Motivation, Productivity, and Quality of Work Life (PADRA-EXER)
The Effect of a 12-Week Structured Workplace Exercise Program on AGIO Productivity, 360-Degree Performance Evaluation, Herzberg Job Motivation, and Walton Quality of Work Life: A Quasi-Experimental Pre-Test/Post-Test Study in a Medical Garment Manufacturing Factory
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This study employs a quasi-experimental, single-group pre-test/post-test design with a mixed-methods (quantitative-qualitative) approach. The study is conducted at a medical protective apparel and healthcare sanitary wear manufacturing plant in Sanandaj, Kurdistan Province, Iran. Workers primarily perform sedentary-to-light manual tasks including fabric cutting, sewing, quality inspection, and packaging under a two-shift rotation system. The study period runs from April to July 2025 (1 Ordibehesht to 24 Tir 1404, Iranian calendar). Baseline (T1) assessments are completed one week before session 1; post-intervention (T2) assessments are completed within one week of session 24. The study protocol was approved by the Research Ethics Committee of Islamic Azad University, Sanandaj Branch (Ethics Code: IR.IAU.SANANDAJ.REC.1405.152). Written informed consent is obtained from all participants before enrolment.
Participants: All 150 employees of the facility are invited for eligibility screening. A licensed occupational medicine physician conducts clinical examinations supplemented by the Physical Activity Readiness Questionnaire (PAR-Q). Employees with uncontrolled cardiovascular disease, severe respiratory disorders, musculoskeletal conditions incompatible with moderate-intensity exercise, pregnancy, or other physician-identified contraindications are excluded. Eligible employees who provide written informed consent are enrolled. Sample size adequacy is confirmed using Cochran's formula for finite populations (N = 150; 95% CI; margin of error = 0.05; p = q = 0.50), and statistical power is verified using G*Power 3.1.
Intervention Protocol: The 12-week structured exercise program comprises 24 sessions (2 × 60 min/week), delivered by a fitness instructor holding a Grade-2 certification from the Physical Fitness Federation of the Islamic Republic of Iran. Sessions are consistently held at 10:00 AM before shift handovers. The facility's dedicated sports hall provides a climate-controlled environment (25-26°C; 60% relative humidity) consistent with ACSM guidelines for moderate-intensity aerobic exercise. Each session includes a 10-minute warm-up with joint mobility and dynamic stretching, a 40-minute main phase combining intermittent aerobic exercise (60-75% of heart rate reserve) with functional core exercises, calisthenics, and cooperative small-sided games, and a 10-minute cool-down with static stretching, spinal elongation, and guided diaphragmatic breathing. Aerobic intensity is targeted at 60-75% of heart rate reserve using the Karvonen formula, monitored via the Borg Rating of Perceived Exertion (RPE; 6-20 scale; target 12-14). All phases are instructor-led; no self-directed activities are included.
Outcome Measures: Four validated instruments are administered at baseline (T1) and post-intervention (T2). (1) The 40-item Herzberg Dual-Factor Motivation Questionnaire (Darchini, 2015) assesses two independent subscales: Intrinsic/Motivator factors (20 items) and Extrinsic/Hygiene factors (20 items), using a 5-point Likert scale. (2) The 26-item AGIO Human Resource Productivity Scale (Hersey and Blanchard, 1980; validated by Mehri, 2013) assesses seven subscales: Ability, Role Clarity, Organizational Support, Motivation, Feedback, Credibility, and Environmental Fit, using a 5-point Likert scale. (3) A 360-degree performance evaluation questionnaire (Poursoltani et al., 2010) collects ratings from four sources: supervisor, peer, subordinate, and self. (4) The Walton Quality of Work Life Questionnaire (Walton, 1973; Iranian validation by Rahimi, 2005) assesses eight dimensions including fair compensation, safe working conditions, and growth opportunities.
Statistical Analysis Plan: All analyses will use IBM SPSS Statistics v26.0. Composite scale scores (≥ 10 items) will be treated as continuous interval-level data for parametric analyses. Shapiro-Wilk tests will verify univariate normality. For the primary pre-post comparisons, paired-samples t-tests will be used with a Bonferroni-adjusted significance threshold. For the cross-sectional association between post-intervention motivation, 360-degree appraisal, and productivity, an enter-method multiple linear regression will be used. A supplementary regression will include T1 motivation as a covariate. Model assumptions will be verified (VIF < 2.0 for multicollinearity; Durbin-Watson for autocorrelation). One-way ANOVA with partial eta-squared will examine whether demographic characteristics moderate post-intervention outcomes. Qualitative interview data from 10 semi-structured interviews will undergo thematic content analysis (open, axial, and selective coding) as a planned exploratory component of the study.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Kurdistan Province
-
Sanandaj, Kurdistan Province, Iran, 6616947455
- PADRA Medical Garment Manufacturing Factory
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Employment at PADRA Medical Garment Manufacturing Factory
- Age between 20 and 60 years
- Successful completion of clinical examination by an occupational medicine specialist
- Successful completion of the PAR-Q (Physical Activity Readiness Questionnaire) with no contraindications
- Voluntary written informed consent to participate in the study
- Willingness to attend 2 exercise sessions per week for 12 weeks
Exclusion Criteria:
- Uncontrolled cardiovascular diseases (e.g., uncontrolled hypertension, recent myocardial infarction)
- Severe respiratory disorders (e.g., severe asthma, COPD)
- Musculoskeletal problems that contraindicate moderate-intensity physical activity
- Any medical contraindication for moderate-intensity exercise as determined by occupational medicine specialist
- Pregnancy
- Withdrawal of informed consent at any stage of the study
- Failure to complete pre-test or post-test questionnaires
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Workplace Exercise Intervention Group
Participants received a 12-week structured workplace exercise program consisting of 24 sessions (60 minutes each, 2 sessions per week).
Each session included a 10-minute warm-up with dynamic movements and joint mobilization, a 40-minute main phase combining intermittent aerobic exercise (60-75% of heart rate reserve) with functional endurance training and team-based games (volleyball, small-sided football, passing drills), and a 10-minute cool-down with static stretching, relaxation, and guided diaphragmatic breathing.
Exercise intensity was monitored using the Borg Rating of Perceived Exertion (RPE) scale with a target range of 12-14.
The intervention was conducted at the factory's adjacent sports hall at 10:00 AM, with ambient temperature maintained at 25-26°C.
Attendance was high: 107 out of 109 participants completed ≥22 of 24 sessions.
No adverse events or protocol deviations were recorded.
Outcomes measured pre- and post-intervention included AGIO productivity, 360-degree perfor
|
A 12-week structured exercise program consisting of 24 sessions (60 minutes each, 2 sessions per week).
Each session includes a 10-minute warm-up with dynamic movements and joint mobilization, a 40-minute main phase combining intermittent aerobic exercise (60-75% of heart rate reserve) with functional endurance training and team-based games (volleyball, small-sided football, passing drills), and a 10-minute cool-down with static stretching, relaxation, and guided diaphragmatic breathing.
Intensity monitored by Borg RPE scale (target 12-14).
Conducted at factory sports hall, 10:00 AM, 25-26°C.
No adverse events recorded.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
AGIO Productivity Score
Zeitfenster: Baseline (Week 0) and Post-Intervention (Week 12)
|
Measured using the AGIO Human Resource Productivity Scale (Hersey and Blanchard, 1980) with 7 subscales: ability, role clarity, organizational support, motivation, feedback, credibility, and environmental adaptability.
Scores range from 1 to 5, with higher scores indicating greater productivity.
|
Baseline (Week 0) and Post-Intervention (Week 12)
|
|
360-Degree Performance Evaluation Score
Zeitfenster: Baseline (Week 0) and Post-Intervention (Week 12)
|
Description: Measured using the 360-Degree Performance Evaluation Questionnaire (Poursoltani et al., 2010) with 4 sources: supervisor, peer, subordinate, and self.
Scores range from 1 to 5, with higher scores indicating better performance.
|
Baseline (Week 0) and Post-Intervention (Week 12)
|
|
Herzberg Job Motivation Score
Zeitfenster: Baseline (Week 0) and Post-Intervention (Week 12)
|
Measured using the Herzberg Dual-Factor Motivation Questionnaire (Darchini, 2015) assessing intrinsic (motivational) and extrinsic (hygiene) factors.
Scores range from 1 to 5, with higher scores indicating greater job motivation.
|
Baseline (Week 0) and Post-Intervention (Week 12)
|
|
Walton Quality of Work Life Score
Zeitfenster: Baseline (Week 0) and Post-Intervention (Week 12)
|
Measured using the Walton Quality of Work Life Questionnaire (Walton, 1973; Iranian validation by Rahimi, 2005) with 8 dimensions including fair compensation, safe working conditions, and growth opportunities.
Scores range from 1 to 5, with higher scores indicating better quality of work life.
|
Baseline (Week 0) and Post-Intervention (Week 12)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
AGIO Subscale Scores
Zeitfenster: Baseline (Week 0) and Post-Intervention (Week 12)
|
Individual subscale scores of the AGIO Human Resource Productivity Scale (Hersey and Blanchard, 1980) including Ability, Role Clarity, Organizational Support, Motivation, Feedback, Credibility, and Environmental Fit.
Each subscale score ranges from 1 to 5, with higher scores indicating greater productivity.
|
Baseline (Week 0) and Post-Intervention (Week 12)
|
|
Herzberg Factor Scores
Zeitfenster: Baseline (Week 0) and Post-Intervention (Week 12)
|
Separate scores for the Intrinsic/Motivator factors and Extrinsic/Hygiene factors of the Herzberg Dual-Factor Motivation Questionnaire (Darchini, 2015).
Each factor score ranges from 1 to 5, with higher scores indicating greater job motivation.
|
Baseline (Week 0) and Post-Intervention (Week 12)
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
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
Andere Studien-ID-Nummern
- PADRA-EXER-1404
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
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 .