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Completed

NCT Number: NCT04190290

Anorexia Nervosa Inpatient Physiotherapy Adapted Program

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.

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Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders

Age range

12 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Reina Sofía

Murcia, 30003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women
  • Hospitalized
  • Anorexia nervosa
  • Body mass index (kg/m2) < 16

Exclusion criteria

  • Men

Treatment and study plan

Physiotherapy Adapted Program

Other

3 days / week mobilisations and respiratory exercises and body image exercises

Other names: Adapted exercises

Evaluation and Control

Diagnostic Test

Manual muscle test MRC score, peak-expiratory-flow test, hand strength test, 6 minutes walking test, SF-36, EDI-3 and EDQOL

Primary outcomes

  1. 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

  2. Resistance

    Time frame: 4 weeks

    Cardiopulmonary function with six minute walking test. Calculate the distance walked in 6 minutes in metres.

  3. 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. 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)

Secondary outcomes

  1. Others

    Time frame: 4 weeks

    Biological data (potassium, transaminases), weight in kilogrammes and body mass index (kg/m2)

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Official study title

Efficacy of Adapted Program of Physiotherapy in Hospitalized Person by Anorexia Nervosa With Several Undernutrition

Acronym: ANIPAP

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Dec 9, 2019
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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