- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04190290
Anorexia Nervosa Inpatient Physiotherapy Adapted Program (ANIPAP)
Efficacy of Adapted Program of Physiotherapy in Hospitalized Person by Anorexia Nervosa With Several Undernutrition
Anorexia nervosa (AN) is a psychiatric pathology with several somatics consequences that increase the vital risk. The prevalence in AN is between 0.9-3% and AN has the most elevated mortality in the psychiatric pathologies (10% in the hospitalized patients).
The collateral effects by several undernourishment has been studied but the autonomy and muscle strength research is insufficient.
Physiotherapy research study body image, basic body awareness therapy, relaxation and quality of life.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJETIVE: Develop a physiotherapy program to increase muscle strength and quality of life in anorexia nervosa hospitalized patients.
METHOD: 4 weeks of adapted exercises (3 days/week) in anorexia nervosa patients with body max index under 16 in interventional group.
And evaluation program once a week in interventional group and control group.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Murcia, Spain, 30003
- University Hospital Reina Sofia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women
- Hospitalized
- Anorexia nervosa
- Body mass index (kg/m2) < 16
Exclusion Criteria:
- Men
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Mobilizations and exercises training Respiratory exercises Body image exercises
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3 days / week mobilisations and respiratory exercises and body image exercises
Other Names:
Manual muscle test MRC score, peak-expiratory-flow test, hand strength test, 6 minutes walking test, SF-36, EDI-3 and EDQOL
|
Active Comparator: Control
Muscle strength evaluation and Eating behavior evaluation and Quality of life
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Manual muscle test MRC score, peak-expiratory-flow test, hand strength test, 6 minutes walking test, SF-36, EDI-3 and EDQOL
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Strength
Time Frame: 4 weeks
|
Muscle strength with Manual Muscle Test MRC Scale (0 no articular motion/no muscle contraction.
5 complete articular motion/normal muscle resistance) and hand strength in kilogrammes and Peak Expiratory Flow level in litres/minute
|
4 weeks
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Resistance
Time Frame: 4 weeks
|
Cardiopulmonary function with six minute walking test.
Calculate the distance walked in 6 minutes in metres.
|
4 weeks
|
Life
Time Frame: 4 weeks
|
The Short Form Health Survey test (SF-36) is a patient-reported survey of patient health. Spanish version with 36 questions. Eating Disorders Quality of Life test (EDQOL) is a simple questionnaire with 25 questions (9 psychological, 6 physical/cognitive, 5 financial, 5 work/school). |
4 weeks
|
Behavior
Time Frame: 4 weeks
|
Eating disorders inventory (EDI-3).
This test is a self-report questionnaire used to assess the presence of eating disorders.
The test has 12 items: 3 items specific of eating disorders (thinness obsession, bulimia, body dissatisfaction) and 9 psychological items (self esteem, personal alignment, interpersonal insecurity, interpersonal distrust, deficit introspective, emotional disturbance, perfectionism, asceticism, fear of maturity)
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Others
Time Frame: 4 weeks
|
Biological data (potassium, transaminases), weight in kilogrammes and body mass index (kg/m2)
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Umu
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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