Physical CapacityNCT04995718
Intelligent Physical Exercise Training (IPET) in the Offshore Wind Industry: A Feasibility Study
A study testing Intelligent Physical Exercise Training (IPET) in people with Physical Capacity, run by University of Southern Denmark at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Capacity
- What is being tested?
- Intelligent Physical Exercise Training (IPET)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Feb 2020to 5 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Wind technician Valid fitness and medical certificate Adult >18 years
Who cannot join
- Hypertensive with blood pressure above 165 mmHg systolic and 105 mmHg diastolic.
- Severe pain would exclude technicians from strength measurements
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Physical Activity and Health at Work, Department of Sports Science and Clinical Biomechanics
Odense, 5230
About this 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.
Read the detailed 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.
- Conditions
- Physical Capacity
- Being tested
- Intelligent Physical Exercise Training (IPET)
- Keywords
- Physical Capacity, Feasibility, Workplace exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent Physical Exercise Training (IPET)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| IPET: Intelligent physical exercise training during working hours | Experimental | Workplace physical exercise Receives: Other: Intelligent Physical Exercise Training (IPET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From T2 to T3 (three months)
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")
Measured: One time after 8 weeks (between T2 and T3)
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.
Measured: From T2 to T3 (three months)
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.
Measured: From T2 to T3 (three months)
Secondary outcomes (5)
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.
Measured: Nine months (changes between T1, T2 and T3)
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.
Measured: Nine months (changes between T1, T2 and T3)
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.
Measured: Nine months (changes between T1, T2 and T3)
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
Measured: Nine months (changes between T1, T2 and T3)
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.
Measured: Nine months (changes between T1, T2 and T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start25 Feb 2020
- Primary completion5 Nov 2020
- Study completion5 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical CapacityStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Ørsted A/S
- Responsible party
- Principal investigator, Anne Skov Oestergaard, University of Southern Denmark
- Investigators
- Karen Søgaard, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995718
- Sponsor's protocol ID
- S-20182000-161
- Status last verified
- Jul 2021
- First submitted
- 15 Jul 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oestergaard AS, Sandal LF, Smidt TF, Sogaard K. Intelligent Physical Exercise Training (IPET) in the offshore wind industry: a feasibility study with an adjusted conceptual model. Pilot Feasibility Stud. 2022 Jul 23;8(1):152. doi: 10.1186/s40814-022-01106-z.
PubMed 35870979
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent Physical Exercise Training (IPET) in the Offshore Wind Industry: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04995718
- Acronym / sponsor ID
- S-20182000-161
- Conditions
- Physical Capacity
- Keywords
- Physical Capacity, Feasibility, Workplace exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Ørsted A/S
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPET: Intelligent physical exercise training during working hours | Experimental | Other: Intelligent Physical Exercise Training (IPET)Workplace physical exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Wind technician Valid fitness and medical certificate Adult >18 years
Key exclusion criteria (2 listed)
- Hypertensive with blood pressure above 165 mmHg systolic and 105 mmHg diastolic.
- Severe pain would exclude technicians from strength measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | IPET: Intelligent physical exercise training during working hours |
Primary outcome
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.
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")
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.
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.
5 secondary outcomes
Cardiovascular capacity
Time frame: Nine months (changes between T1, T2 and T3)
Muscle strength
Time frame: Nine months (changes between T1, T2 and T3)
Musculoskeletal disorders
Time frame: Nine months (changes between T1, T2 and T3)
Work ability
Time frame: Nine months (changes between T1, T2 and T3)
Physical fitness capacities
Time frame: Nine months (changes between T1, T2 and T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Derived from this study: PubMed 35870979Oestergaard AS, Sandal LF, Smidt TF, Sogaard K. Intelligent Physical Exercise Training (IPET) in the offshore wind industry: a feasibility study with an adjusted conceptual model. Pilot Feasibility Stud. 2022 Jul 23;8(1):152. doi: 10.1186/s40814-022-01106-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Søgaard, PhD principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intelligent Physical Exercise Training (IPET) in people with Physical Capacity, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance (time frame: From T2 to T3 (three months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04995718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.