Musculoskeletal DisordersIRMA05NCT01543893
Effect of Personal Versus Video Instruction in Elastic Resistance Exercise on Technical Execution (IRMA05)
A study testing Video instruction and Personal instruction in people with Musculoskeletal Disorders, run by National Research Centre for the Working Environment, Denmark at 1 site in Denmark.
Trial summary
Resistance training is widely used in training and rehabilitation. During recent years elastic resistance training has become increasingly popular for preventing or relieving neck/shoulder/arm pain among sedentary employees. Read more about this study
- Who is it for?
- Ages 18 to 67 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Disorders
- What is being tested?
- Video instruction and Personal instruction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2012to Jun 2012
- 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 to 67 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- neck or shoulder pain
Who cannot join
- blood pressure above 160/100 mmHg
- pregnancy
- life-threatening disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site
National Research Centre for the Working Environment
Copenhagen, 2100
About this study
Official title: Danish: Integreret Motion på Arbejdspladsen (IRMA) English: Implementation of Exercise at the Workplace
Resistance training is widely used in training and rehabilitation. During recent years elastic resistance training has become increasingly popular for preventing or relieving neck/shoulder/arm pain among sedentary employees. While most research studies documenting positive effects of such interventions have used training instructors, most training in practice does not use an instructor but rather depends on information from other sources such as the internet. Here the investigators examine - in a outcome assessor blinded randomized controlled trial - the effect of 2 weeks elastic resistance training for the neck/shoulder/arm with personal versus video instruction on technical execution.
- Conditions
- Musculoskeletal Disorders
- Being tested
- Video instruction, Personal instruction
- Keywords
- neck pain, shoulder pain, resistance training
- Medical subject headings
- Musculoskeletal Diseases, Neck Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video instructionBehavioural
Participants will receive an elastic resistance tubing, an internet link and a poster with instructions to perform four different elastic resistance exercises Participants are encouraged to perform the exercises daily on weekdays during the next two weeks
Link to exercises: http://www.jobogkrop.dk/Ondt-i-muskler-og-led/Ondt-i-nakke-skulder-og-arm/Elastikoevelser-for-nakke-skulder-og-arm
Personal instructionBehavioural
Participants will receive an elastic resistance tubing, an internet link and a poster with instructions to perform four different elastic resistance exercises Participants are encouraged to perform the exercises daily on weekdays during the next two weeks In addition to the video group, this group will also receive personal instruction during the two weeks.
Link to exercises: http://www.jobogkrop.dk/Ondt-i-muskler-og-led/Ondt-i-nakke-skulder-og-arm/Elastikoevelser-for-nakke-skulder-og-arm
| Study group | Role | What they receive |
|---|---|---|
| Video instruction | Experimental | Participants will receive an elastic resistance tubing, an internet link and a poster with instructions to perform four different elastic resistance exercises Participants are encouraged to perform the exercises daily on weekdays during the next two weeks
Link to exercises: http://www.jobogkrop.dk/Ondt-i-muskler-og-led/Ondt-i-nakke-skulder-og-arm/Elastikoevelser-for-nakke-skulder-og-arm Receives: Behavioral: Video instruction |
| Personal instruction | Active comparator | Participants will receive an elastic resistance tubing, an internet link and a poster with instructions to perform four different elastic resistance exercises Participants are encouraged to perform the exercises daily on weekdays during the next two weeks In addition to the video group, this group will also receive personal instruction during the two weeks.
Link to exercises: http://www.jobogkrop.dk/Ondt-i-muskler-og-led/Ondt-i-nakke-skulder-og-arm/Elastikoevelser-for-nakke-skulder-og-arm Receives: Behavioral: Personal instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical execution
- joint positions will be scored for each individual joint and plane on a 5 point scale according to standard execution according to images
- a total score (primary outcome) will be calculated by summing scores from each individual joint position
Measured: 2 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DisordersStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre for the Working Environment, Denmark
- Sponsor type
- Other government
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Lars L. Andersen, National Research Centre for the Working Environment, Denmark
- Investigators
- Lars L Andersen, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543893
- Sponsor's protocol ID
- IRMA05
- Acronym
- IRMA05
- Status last verified
- Jun 2013
- First submitted
- 28 Feb 2012
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Danish: Integreret Motion på Arbejdspladsen (IRMA) English: Implementation of Exercise at the Workplace
- ClinicalTrials.gov ID
- NCT01543893
- Acronym / sponsor ID
- IRMA05 / IRMA05
- Conditions
- Musculoskeletal Disorders
- Keywords
- neck pain, shoulder pain, resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- National Research Centre for the Working Environment, DenmarkOther government
- Collaborators
- Novo Nordisk A/S
- Study start
- Mar 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 Mar 2012 (estimated)
- 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.
Resistance training is widely used in training and rehabilitation. During recent years elastic resistance training has become increasingly popular for preventing or relieving neck/shoulder/arm pain among sedentary employees. While most research studies documenting positive effects of such interventions have used training instructors, most training in practice does not use an instructor but rather depends on information from other sources such as the internet. Here the investigators examine - in a outcome assessor blinded randomized controlled trial - the effect of 2 weeks elastic resistance training for the neck/shoulder/arm with personal versus video instruction on technical execution.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video instruction | Experimental | Behavioral: Video instructionParticipants will receive an elastic resistance tubing, an internet link and a poster with instructions to perform four different elastic resistance exercises Participants are encouraged to perform the exercises daily on weekdays during the next two weeks Link to exercises: http://www.jobogkrop.dk/Ondt-i-muskler-og-led/Ondt-i-nakke-skulder-og-arm/Elastikoevelser-for-nakke-skulder-og-arm |
| Personal instruction | Active comparator | Behavioral: Personal instructionParticipants will receive an elastic resistance tubing, an internet link and a poster with instructions to perform four different elastic resistance exercises Participants are encouraged to perform the exercises daily on weekdays during the next two weeks In addition to the video group, this group will also receive personal instruction during the two weeks. Link to exercises: http://www.jobogkrop.dk/Ondt-i-muskler-og-led/Ondt-i-nakke-skulder-og-arm/Elastikoevelser-for-nakke-skulder-og-arm |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- neck or shoulder pain
Key exclusion criteria (3 listed)
- blood pressure above 160/100 mmHg
- pregnancy
- life-threatening disease
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 |
|---|---|---|
| Video instructionParticipants will receive an elastic resistance tubing, an internet link and a poster with instructions to perform four different elastic resistance exercises Participants are encouraged to perform the exercises daily on weekdays during the next two weeks Link to exercises: http://www.jobogkrop.dk/Ondt-i-muskler-og-led/Ondt-i-nakke-skulder-og-arm/Elastikoevelser-for-nakke-skulder-og-arm | Behavioural | Video instruction |
| Personal instructionParticipants will receive an elastic resistance tubing, an internet link and a poster with instructions to perform four different elastic resistance exercises Participants are encouraged to perform the exercises daily on weekdays during the next two weeks In addition to the video group, this group will also receive personal instruction during the two weeks. Link to exercises: http://www.jobogkrop.dk/Ondt-i-muskler-og-led/Ondt-i-nakke-skulder-og-arm/Elastikoevelser-for-nakke-skulder-og-arm | Behavioural | Personal instruction |
Primary outcome
Technical execution
Time frame: 2 weeks after randomization
* joint positions will be scored for each individual joint and plane on a 5 point scale according to standard execution according to images * a total score (primary outcome) will be calculated by summing scores from each individual joint position
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 28 Jun 2013.
- Company websiteLink provided by the sponsor.
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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.
Lars L Andersen, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video instruction and Personal instruction in people with Musculoskeletal Disorders, run by National Research Centre for the Working Environment, 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 3 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 28 Jun 2013. 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?
Technical execution (time frame: 2 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2013.