Anorexia Nervosa Inpatient Physiotherapy Adapted Program (ANIPAP)

May 16, 2022 updated by: Emilio José Miñano Garrido, Universidad de Murcia

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

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

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Murcia, Spain, 30003
        • University Hospital Reina Sofia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Men

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
3 days / week mobilisations and respiratory exercises and body image exercises
Other Names:
  • Adapted exercises
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
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
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2018

Primary Completion (Actual)

January 15, 2021

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

November 22, 2019

First Submitted That Met QC Criteria

December 4, 2019

First Posted (Actual)

December 9, 2019

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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