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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04995718
Other study ID # S-20182000-161
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 25, 2020
Est. completion date November 5, 2020

Study information

Verified date July 2021
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

One-arm feasibility study, including a within-group control period, to test compliance, practicality, acceptability and preliminary efficacy of implementing intelligent physical exercise training (IPET) in the offshore wind industry among wind technicians. The exercise program was individually tailored based on the findings from a pre-screening health and physical capacity check and the occupational demands of wind technicians. Primary outcomes were compliance, adherence, adverse events and satisfaction. Secondary outcomes were physical capacity and musculoskeletal disorders. Prior to the feasibility study, intervention mapping was used as a theoretical tool to plan the intervention. The intervention consisted of 1-hour weekly individually tailored exercise training during working hours. Exercise sessions were supervised during the first 8 weeks of the intervention and self-administered the last 4 weeks. The design included a 6 month control period prior to initiating the intervention. Thus, included technicians (n:24) had their health and physical capacity assessed 6 months prior to intervention start (T1), at intervention start (T2) and 12 weeks after (T3) and they responded to questionnaires on musculoskeletal symptoms at all three occasions. Further, a questionnaire customized to the specific intervention was distributed to all technicians 8 weeks after intervention start to assess satisfaction with the exercise program.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date November 5, 2020
Est. primary completion date November 5, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Intelligent Physical Exercise Training (IPET)
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.

Locations

Country Name City State
Denmark Physical Activity and Health at Work, Department of Sports Science and Clinical Biomechanics Odense

Sponsors (2)

Lead Sponsor Collaborator
University of Southern Denmark Ørsted A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compliance 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)
Primary Acceptability 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)
Primary Adherence 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)
Primary Adverse events 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 Cardiovascular capacity 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)
Secondary Muscle strength 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)
Secondary Musculoskeletal disorders 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)
Secondary Work ability 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)
Secondary Physical fitness capacities 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)
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