Joint PainCONEXNCT02043613
Context Effects in Exercise Therapy for Knee and/or Hip Pain
A study testing Contextually enhanced physical surroundings of exercise and Neuromuscular exercise in people with Joint Pain and Knee Pain, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The study is designed to investigate the effect of physical surroundings on the effect of exercise therapy for knee and hip pain. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Joint Pain, Knee Pain, Hip Pain
- What is being tested?
- Contextually enhanced physical surroundings of exercise and Neuromuscular exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Mar 2015
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 35 years or older
- Self-report of knee and/or hip pain within the last 3 months.
- Willing and able to attend exercise therapy at the University of Southern Denmark, Odense M twice weekly.
Who cannot join
- Co-morbidities or contraindication prohibiting to participation in exercise therapy.
- Unable to fill-out questionnaires, or to speak, read or understand Danish.
- Already participating in exercise therapy*, having had surgery to the hip/knee within the last 3 months or on waiting list for joint surgery within the coming 6 months. (*defined as supervised exercise program by physiotherapist, systematic strength training etc. with duration of 6 weeks or more)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research Unit of Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark
Odense, 5230
About this study
Official title: Effect of Physical Surroundings on Effects From Exercise as Treatment for Hip or Knee Pain: A Double-blind Randomized Controlled Clinical Trial
The study is designed to investigate the effect of physical surroundings on the effect of exercise therapy for knee and hip pain.
Read the detailed description
Context effect have been shown to be influential in health-care settings, such as hospitals. This study investigates if context effects can be caused by the physical surroundings of exercise.
The study is designed as a double-blind randomized controlled clinical trial. Patients with knee and/or hip pain with a duration of a least 3 months are included in the trial and randomly assigned to 3 groups.
- Exercise in pre-existing, standard room
- Exercise in contextually enhanced room.
- Waiting list.
The intervention consists markedly different between the two exercise rooms. The physical surroundings are described by factors such as acoustics, light source and intensity, decorations and air quality.
The exercise program applied is based on a previously investigated neuromuscular exercise program, NEMEX. The same program is performed in both exercise rooms. Consequently, only the physical surroundings differ between intervention groups.
Patients' "global perceived effect" is used as the primary outcome assessed at 8 weeks follow-up.
- Conditions
- Joint Pain, Knee Pain, Hip Pain, Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- Contextually enhanced physical surroundings of exercise, Neuromuscular exercise
- Keywords
- Joint pain, Context effects, Placebo effect, Exercise treatment
- Medical subject headings
- Arthralgia, Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contextually enhanced physical surroundings of exerciseOther
Different physical surroundings of exercise may affects the patients differently and consequently influence the effect of exercise. The exercise rooms are different from each other on parameters such as source of lighting, acoustics, materials and decorations.
The differences with the physical surroundings of exercise is the primary intervention for this study.
Neuromuscular exerciseOther
The neuromuscular exercise program is the same across the two exercise groups. Consequently, this intervention is not the primary intervention of this study. The exercise program is based on the previously reported NEMEX program designed for patients with hip or knee osteoarthritis, originally published by Ageberg et al, 2010 in BMCMusculoskeletal Disorders.
| Study group | Role | What they receive |
|---|---|---|
| Exercise in standard room | Active comparator | Intervention: Exercise
Patients exercise in standard physical surroundings. The room is marked by years of use. The room is placed in the basement, has artificial lighting, poor acoustics and bare concrete walls. Receives: Other: Neuromuscular exercise |
| Exercise in a contexually enhanced room | Experimental | Intervention: Exercise + contextually enhanced physical surroundings
Patients exercise in a contextually enhanced room. The room has both artificial lighting and daylight, view of a recreational park, better acoustics, decorations among other factors, which may cause or enhance the context effect. Receives: Other: Contextually enhanced physical surroundings of exercise; Other: Neuromuscular exercise |
| Waiting list | No intervention | Patients on waiting list are included, baseline tested and placed on a waiting-list for a 8 week period and tested at 8 weeks follow-up. The group is representative of the natural cause of disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' Global Perceived Effect
Patients indicate their perception of the global effect of the intervention on a 7 point likert scale ranging from "substantially worse" to "no change" to "substantially improved". The scale is balanced around the 'no change' response with 3 steps in each direction, respectively deterioration or improvement.
Measured: 8 weeks
Secondary outcomes (4)
Change from baseline in KOOS (The Knee injury and Osteoarthritis Outcome Score) or HOOS (The Hip Dysfunction and Osteoarthritis Score), respectively
Measured: Baseline, 4 weeks, 8 weeks
Change from baseline in The 36-item Short-Form Health Survey (SF-36)
Measured: Baseline, 4 weeks, 8 weeks
Change from baseline in Arthritis Self-Efficacy Scale
A modified version of the Arthritis Self-Efficacy Scale consisting of 11 items scoring patient reported self-efficacy
Measured: baseline, 4 weeks, 8 weeks.
Patient satisfaction with physical surroundings
Patients are asked to indicate their level of satisfaction with different elements of the physical surroundings.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Joint PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, The Danish Rheumatism Association (funding)
- Responsible party
- Principal investigator, Louise Fleng Sandal, University of Southern Denmark
- Investigators
- Louise F. Sandal, MSc, Principal investigator, Research Unit of Musculoskeletal Function and Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043613
- Sponsor's protocol ID
- S-20130130
- Acronym
- CONEX
- Status last verified
- Mar 2015
- First submitted
- 20 Jan 2014
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ageberg E, Link A, Roos EM. Feasibility of neuromuscular training in patients with severe hip or knee OA: the individualized goal-based NEMEX-TJR training program. BMC Musculoskelet Disord. 2010 Jun 17;11:126. doi: 10.1186/1471-2474-11-126.
PubMed 20565735Sandal LF, Thorlund JB, Moore AJ, Ulrich RS, Dieppe PA, Roos EM. Room for improvement: a randomised controlled trial with nested qualitative interviews on space, place and treatment delivery. Br J Sports Med. 2019 Mar;53(6):359-367. doi: 10.1136/bjsports-2016-097448. Epub 2017 Aug 2.
PubMed 28768617Sandal LF, Thorlund JB, Ulrich RS, Dieppe PA, Roos EM. Exploring the effect of space and place on response to exercise therapy for knee and hip pain--a protocol for a double-blind randomised controlled clinical trial: the CONEX trial. BMJ Open. 2015 Mar 27;5(3):e007701. doi: 10.1136/bmjopen-2015-007701.
PubMed 25818278
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Surroundings on Effects From Exercise as Treatment for Hip or Knee Pain: A Double-blind Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02043613
- Acronym / sponsor ID
- CONEX / S-20130130
- Conditions
- Joint Pain, Knee Pain, Hip Pain, Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- Joint pain, Context effects, Placebo effect, Exercise treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- The Swedish Research Council, The Danish Rheumatism Association (funding)
- Study start
- Feb 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 23 Jan 2014 (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.
The study is designed to investigate the effect of physical surroundings on the effect of exercise therapy for knee and hip pain.
Detailed description
Context effect have been shown to be influential in health-care settings, such as hospitals. This study investigates if context effects can be caused by the physical surroundings of exercise.
The study is designed as a double-blind randomized controlled clinical trial. Patients with knee and/or hip pain with a duration of a least 3 months are included in the trial and randomly assigned to 3 groups.
- Exercise in pre-existing, standard room
- Exercise in contextually enhanced room.
- Waiting list.
The intervention consists markedly different between the two exercise rooms. The physical surroundings are described by factors such as acoustics, light source and intensity, decorations and air quality.
The exercise program applied is based on a previously investigated neuromuscular exercise program, NEMEX. The same program is performed in both exercise rooms. Consequently, only the physical surroundings differ between intervention groups.
Patients' "global perceived effect" is used as the primary outcome assessed at 8 weeks follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise in standard room | Active comparator | Other: Neuromuscular exerciseIntervention: Exercise Patients exercise in standard physical surroundings. The room is marked by years of use. The room is placed in the basement, has artificial lighting, poor acoustics and bare concrete walls. |
| Exercise in a contexually enhanced room | Experimental | Other: Contextually enhanced physical surroundings of exercise, Other: Neuromuscular exerciseIntervention: Exercise + contextually enhanced physical surroundings Patients exercise in a contextually enhanced room. The room has both artificial lighting and daylight, view of a recreational park, better acoustics, decorations among other factors, which may cause or enhance the context effect. |
| Waiting list | No intervention | –Patients on waiting list are included, baseline tested and placed on a waiting-list for a 8 week period and tested at 8 weeks follow-up. The group is representative of the natural cause of disease. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 35 years or older
- Self-report of knee and/or hip pain within the last 3 months.
- Willing and able to attend exercise therapy at the University of Southern Denmark, Odense M twice weekly.
Key exclusion criteria (3 listed)
- Co-morbidities or contraindication prohibiting to participation in exercise therapy.
- Unable to fill-out questionnaires, or to speak, read or understand Danish.
- Already participating in exercise therapy*, having had surgery to the hip/knee within the last 3 months or on waiting list for joint surgery within the coming 6 months. (*defined as supervised exercise program by physiotherapist, systematic strength training etc. with duration of 6 weeks or more)
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 |
|---|---|---|
| Contextually enhanced physical surroundings of exerciseDifferent physical surroundings of exercise may affects the patients differently and consequently influence the effect of exercise. The exercise rooms are different from each other on parameters such as source of lighting, acoustics, materials and decorations. The differences with the physical surroundings of exercise is the primary intervention for this study. | Other | Exercise in a contexually enhanced room |
| Neuromuscular exerciseThe neuromuscular exercise program is the same across the two exercise groups. Consequently, this intervention is not the primary intervention of this study. The exercise program is based on the previously reported NEMEX program designed for patients with hip or knee osteoarthritis, originally published by Ageberg et al, 2010 in BMCMusculoskeletal Disorders. | Other | Exercise in a contexually enhanced room, Exercise in standard room |
Primary outcome
Patients' Global Perceived Effect
Time frame: 8 weeks
Patients indicate their perception of the global effect of the intervention on a 7 point likert scale ranging from "substantially worse" to "no change" to "substantially improved". The scale is balanced around the 'no change' response with 3 steps in each direction, respectively deterioration or improvement.
4 secondary outcomes
Change from baseline in KOOS (The Knee injury and Osteoarthritis Outcome Score) or HOOS (The Hip Dysfunction and Osteoarthritis Score), respectively
Time frame: Baseline, 4 weeks, 8 weeks
Change from baseline in The 36-item Short-Form Health Survey (SF-36)
Time frame: Baseline, 4 weeks, 8 weeks
Change from baseline in Arthritis Self-Efficacy Scale
Time frame: baseline, 4 weeks, 8 weeks.
Patient satisfaction with physical surroundings
Time frame: 8 weeks
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 27 Mar 2015.
- Background: PubMed 20565735Ageberg E, Link A, Roos EM. Feasibility of neuromuscular training in patients with severe hip or knee OA: the individualized goal-based NEMEX-TJR training program. BMC Musculoskelet Disord. 2010 Jun 17;11:126. doi: 10.1186/1471-2474-11-126.
- Derived from this study: PubMed 28768617Sandal LF, Thorlund JB, Moore AJ, Ulrich RS, Dieppe PA, Roos EM. Room for improvement: a randomised controlled trial with nested qualitative interviews on space, place and treatment delivery. Br J Sports Med. 2019 Mar;53(6):359-367. doi: 10.1136/bjsports-2016-097448. Epub 2017 Aug 2.
- Derived from this study: PubMed 25818278Sandal LF, Thorlund JB, Ulrich RS, Dieppe PA, Roos EM. Exploring the effect of space and place on response to exercise therapy for knee and hip pain--a protocol for a double-blind randomised controlled clinical trial: the CONEX trial. BMJ Open. 2015 Mar 27;5(3):e007701. doi: 10.1136/bmjopen-2015-007701.
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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.
Louise F. Sandal, MSc principal investigator
Research Unit of Musculoskeletal Function and Physiotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contextually enhanced physical surroundings of exercise and Neuromuscular exercise in people with Joint Pain and Knee Pain, 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 3 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 27 Mar 2015. 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?
Patients' Global Perceived Effect (time frame: 8 weeks). 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 NCT02043613, which also lists 3 linked publications.
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 27 Mar 2015.