- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04995718
Intelligent Physical Exercise Training (IPET) in the Offshore Wind Industry: A Feasibility Study
A study to assess the feasibility of a 12-week exercise intervention aiming at improving the physical capacity and health of wind technicians.
it was hypothesized that the intervention would be well-accepted by workers and show high compliance and clinically relevant increases in physical capacities among wind technicians.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Odense, Denmark, 5230
- Physical Activity and Health at Work, Department of Sports Science and Clinical Biomechanics
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Wind technician Valid fitness and medical certificate Adult >18 years
Exclusion Criteria:
Hypertensive with blood pressure above 165 mmHg systolic and 105 mmHg diastolic.
Severe pain would exclude technicians from strength measurements
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: IPET: Intelligent physical exercise training during working hours
Workplace physical exercise
|
Wind technicians performed 1-hour weekly individualized physical exercise training during working hours.
The specific content of the exercise program was based on the specific job exposure profile, the physical capacity profile and the physical health profile of the employee.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compliance
Time Frame: From T2 to T3 (three months)
|
The appointed supervisors tracked compliance during the first 8 weeks of the exercise intervention (192 possible sessions) on behalf of all participants. Compliance was recorded if a WT attended the planned (and facilitated) session and is reported in percentage of possible sessions. During the last four weeks (self-administered exercise), participants were asked to report attendance in a similar way by phone to the supervisor or health and safety representative or by filling out a record located at the onshore facility. Missing reportings were interpreted as non-compliance. |
From T2 to T3 (three months)
|
|
Acceptability
Time Frame: One time after 8 weeks (between T2 and T3)
|
Acceptability with the on-site part of the intervention was evaluated after the first 8 weeks using a survey customised to the intervention and to the specific target group.
Questions concerned overall acceptability and satisfaction with workplace exercise programmes in general and the specific content of this intervention.
Responses were reported on a 5-point Likert scale (from "Strongly disagree" to Strongly agree")
|
One time after 8 weeks (between T2 and T3)
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Adherence
Time Frame: From T2 to T3 (three months)
|
The appointed supervisors tracked adherence during the first 8 weeks of the exercise intervention (192 possible sessions) on behalf of all participants. Adherence was reached and reported if the WT completed the exercise programme as prescribed, meaning that they did not deviate from the structure of the individual exercise programme (exercise selection (or approved alternative exercises), volume and intensity). Adherence is reported in percentage of possible sessions. During the last four weeks (self-administered exercise), participants were asked to report attendance in a similar way by phone to the supervisor or health and safety representative or by filling out a record located at the onshore facility. Missing reportings were interpreted as non-adherence. |
From T2 to T3 (three months)
|
|
Adverse events
Time Frame: From T2 to T3 (three months)
|
Supervisors were asked to record mild (e.g.
soreness beyond expected levels) and serious adverse events (safety related incidents, e.g.
dropped objects and sprains/strains associated with conducting the exercises) related to the training sessions.
Adverse events were reported in absolute numbers.
|
From T2 to T3 (three months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiovascular capacity
Time Frame: Nine months (changes between T1, T2 and T3)
|
Cardiovascular capacity tests were conducted at three time points: T1 (6 months prior to intervention start), T2 (intervention start) and T3 (after 12 weeks). Cardiovascular capacity (relative VO2max expressed in ml O2/kg/min) was indirectly assessed using the submaximal Chester Step Test on a 30 cm step. |
Nine months (changes between T1, T2 and T3)
|
|
Muscle strength
Time Frame: Nine months (changes between T1, T2 and T3)
|
Muscle strength measurements were performed as maximal voluntary contractions of the forearm using a hand grip dynamometer and isometric shoulder abduction using hand-held dynamometry.
Forearm and shoulder strength were assessed three times for the dominant arm and the maximal values were reported in kilos as means +/- SD.
|
Nine months (changes between T1, T2 and T3)
|
|
Musculoskeletal disorders
Time Frame: Nine months (changes between T1, T2 and T3)
|
Musculoskeletal disorders were assessed in terms of prevalence and severity for 9 different body parts using the Nordic Musculoskeletal Questionnaire, and cases were included if WTs had experienced symptoms for more than 1 day and with an average symptom severity of ≤ 1 (0-10) within the past 3 months.
|
Nine months (changes between T1, T2 and T3)
|
|
Work ability
Time Frame: Nine months (changes between T1, T2 and T3)
|
Singe-item from the work ability index assessing current work ability compared to lifetime best an 11-point scale (0-10).
Reported as mean +/- SD
|
Nine months (changes between T1, T2 and T3)
|
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Physical fitness capacities
Time Frame: Nine months (changes between T1, T2 and T3)
|
The validated Strøyer-scale assessing 5 items (aerobic fitness, muscle strength, endurance, flexibility and balance) on a 10 point-scales (1-10), with 1 indicating 5 indicating average physical capacity compared with peers.
|
Nine months (changes between T1, T2 and T3)
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- S-20182000-161
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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