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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04190290
Other study ID # UMU
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 11, 2018
Est. completion date May 1, 2022

Study information

Verified date May 2022
Source Universidad de Murcia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date May 1, 2022
Est. primary completion date January 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 12 Years and older
Eligibility Inclusion Criteria: - Women - Hospitalized - Anorexia nervosa - Body mass index (kg/m2) < 16 Exclusion Criteria: - Men

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physiotherapy Adapted Program
3 days / week mobilisations and respiratory exercises and body image exercises
Diagnostic Test:
Evaluation and Control
Manual muscle test MRC score, peak-expiratory-flow test, hand strength test, 6 minutes walking test, SF-36, EDI-3 and EDQOL

Locations

Country Name City State
Spain University Hospital Reina Sofía Murcia

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Strength 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
Primary Resistance Cardiopulmonary function with six minute walking test. Calculate the distance walked in 6 minutes in metres. 4 weeks
Primary Life 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
Primary Behavior 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 Others Biological data (potassium, transaminases), weight in kilogrammes and body mass index (kg/m2) 4 weeks
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