ObesityNCT01451892
Dance Therapy and Obesity
A study testing Dance Therapy and patient education in people with Obesity, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Title: The effect of dance-therapy on the functional capacity, body image and quality of life of patients with advanced obesity Project duration: 33 months (August 2010 to June 2013) Clinical context: Obesity has reached epidemic proportions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Dance Therapy and patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2010to Feb 2014
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Person with obesity (BMI ≥ 30)
- Aged > 18 years old
- Being able to walk 10 meters without a walking aid
Who cannot join
- Foot ulcer at the moment of data acquisition
- Orthopaedic, surgical or neurological (other than diabetic neuropathy ) problems which af-fect patient's gait
- Non diabetic neuropathy (Charcot, chronic alcohol consumption, thyroid dysfunction)
- Mental diseases interfering with group therapies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dance Therapy on the Functional Capacity of Patients With Advanced Obesity
Title:
The effect of dance-therapy on the functional capacity, body image and quality of life of patients with advanced obesity
Read more
Project duration:
33 months (August 2010 to June 2013)
Clinical context:
Obesity has reached epidemic proportions. The gait and balance problems in obese people and the associated decreased functional capacity and risk of falling highlight the need to evaluate the benefits of specific treatments on these problems. Attention should be paid not only to metabolic management but also to the physical rehabilitation required in cases of advanced obesity.
Objectives:
The aim of this study is to evaluate the efficacy of dance-therapy on functional capacity (walking ability, postural control and physical activity level), body image and quality of life of patients with advanced obesity.
- Conditions
- Obesity
- Being tested
- Dance Therapy, patient education
- Keywords
- Obesity, dance, gait, balance, posture, dance therapy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance TherapyOther
overweight individuals participating in a patient education program for obese people combined with specific dance-therapy
patient educationOther
overweight individuals participating in a patient education program
| Study group | Role | What they receive |
|---|---|---|
| Dance therapy | Experimental | overweight individuals participating in a patient education program for obese people combined with specific dance-therapy Receives: Other: Dance Therapy |
| Education | Active comparator | overweight individuals participating in a patient education ambulatory program for obese people Receives: Other: patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in comfortable gait speed
Measured: 0, 36 weeks, 6 months
Secondary outcomes (1)
Change in functional capacities
- Change in cadence during normal gait(steps per minute)
- Change in stride length during normal gait (meters)
- Change in stride to stride variability during normal gait
- Change in postural control: Displacement of the centre of pressure (COP) while standing on a stable and unstable surface
- Change in functional parameters: Increase in maximal walking distance covered in 6 minutes (meters)
- Change in required time to realize the Timed Up and Go Test (seconds)
- Change in the Physical Activity Level and Total Energy expenditure
Measured: 0, 36 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startJul 2010
- Primary completionFeb 2014
- Study completionFeb 2014
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 ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- University of Applied Sciences of Western Switzerland
- Responsible party
- Principal investigator, Lara Allet, University of Applied Sciences of Western Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451892
- Sponsor's protocol ID
- 10-072
- Other IDs
- 13DPD6_132361/1
- Status last verified
- Dec 2014
- First submitted
- 5 Oct 2011
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Allet L, Muller-Pinget S, Punt I, Edelsten C, Ballif A, Golay A, Pataky Z. Dance therapy combined with patient education improves quality of life of persons with obesity: A pilot feasibility study for a randomised controlled trial. Obes Res Clin Pract. 2017 Jan-Feb;11(1):79-87. doi: 10.1016/j.orcp.2016.03.005. Epub 2016 Apr 3.
PubMed 27053574
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dance Therapy on the Functional Capacity of Patients With Advanced Obesity
- ClinicalTrials.gov ID
- NCT01451892
- Acronym / sponsor ID
- 10-072
- Conditions
- Obesity
- Keywords
- Obesity, dance, gait, balance, posture, dance therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- University of Applied Sciences of Western Switzerland
- Study start
- Jul 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 14 Oct 2011 (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.
Title:
The effect of dance-therapy on the functional capacity, body image and quality of life of patients with advanced obesity
Project duration:
33 months (August 2010 to June 2013)
Clinical context:
Obesity has reached epidemic proportions. The gait and balance problems in obese people and the associated decreased functional capacity and risk of falling highlight the need to evaluate the benefits of specific treatments on these problems. Attention should be paid not only to metabolic management but also to the physical rehabilitation required in cases of advanced obesity.
Objectives:
The aim of this study is to evaluate the efficacy of dance-therapy on functional capacity (walking ability, postural control and physical activity level), body image and quality of life of patients with advanced obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dance therapy | Experimental | Other: Dance Therapyoverweight individuals participating in a patient education program for obese people combined with specific dance-therapy |
| Education | Active comparator | Other: patient educationoverweight individuals participating in a patient education ambulatory program for obese people |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Person with obesity (BMI ≥ 30)
- Aged > 18 years old
- Being able to walk 10 meters without a walking aid
Key exclusion criteria (4 listed)
- Foot ulcer at the moment of data acquisition
- Orthopaedic, surgical or neurological (other than diabetic neuropathy ) problems which af-fect patient's gait
- Non diabetic neuropathy (Charcot, chronic alcohol consumption, thyroid dysfunction)
- Mental diseases interfering with group therapies
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 |
|---|---|---|
| Dance Therapyoverweight individuals participating in a patient education program for obese people combined with specific dance-therapy | Other | Dance therapy |
| patient educationoverweight individuals participating in a patient education program | Other | Education |
Primary outcome
Change in comfortable gait speed
Time frame: 0, 36 weeks, 6 months
1 secondary outcome
Change in functional capacities
Time frame: 0, 36 weeks, 6 months
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 16 Dec 2014.
- Derived from this study: PubMed 27053574Allet L, Muller-Pinget S, Punt I, Edelsten C, Ballif A, Golay A, Pataky Z. Dance therapy combined with patient education improves quality of life of persons with obesity: A pilot feasibility study for a randomised controlled trial. Obes Res Clin Pract. 2017 Jan-Feb;11(1):79-87. doi: 10.1016/j.orcp.2016.03.005. Epub 2016 Apr 3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance Therapy and patient education in people with Obesity, run by University Hospital, Geneva at 1 site in Switzerland.
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 4 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 16 Dec 2014. 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 Switzerland. 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?
Change in comfortable gait speed (time frame: 0, 36 weeks, 6 months). 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 NCT01451892, 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 16 Dec 2014.