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Anorexia Nervosa Inpatient Physiotherapy Adapted Program (ANIPAP)

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Physiotherapy Adapted Program
Evaluation and Control
Sponsored by
Universidad de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Anorexia nervosa, Muscle strength, Peak-expiratory-flow, Quality of life

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Men

Sites / Locations

  • University Hospital Reina Sofía

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Mobilizations and exercises training Respiratory exercises Body image exercises

Muscle strength evaluation and Eating behavior evaluation and Quality of life

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 22, 2019
Last Updated
May 16, 2022
Sponsor
Universidad de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT04190290
Brief Title
Anorexia Nervosa Inpatient Physiotherapy Adapted Program
Acronym
ANIPAP
Official Title
Efficacy of Adapted Program of Physiotherapy in Hospitalized Person by Anorexia Nervosa With Several Undernutrition
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 11, 2018 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Anorexia nervosa, Muscle strength, Peak-expiratory-flow, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Quasi experimental prospective study
Masking
ParticipantOutcomes Assessor
Masking Description
Randomized group
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Mobilizations and exercises training Respiratory exercises Body image exercises
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Muscle strength evaluation and Eating behavior evaluation and Quality of life
Intervention Type
Other
Intervention Name(s)
Physiotherapy Adapted Program
Other Intervention Name(s)
Adapted exercises
Intervention Description
3 days / week mobilisations and respiratory exercises and body image exercises
Intervention Type
Diagnostic Test
Intervention Name(s)
Evaluation and Control
Intervention Description
Manual muscle test MRC score, peak-expiratory-flow test, hand strength test, 6 minutes walking test, SF-36, EDI-3 and EDQOL
Primary Outcome Measure Information:
Title
Strength
Description
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
Time Frame
4 weeks
Title
Resistance
Description
Cardiopulmonary function with six minute walking test. Calculate the distance walked in 6 minutes in metres.
Time Frame
4 weeks
Title
Life
Description
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).
Time Frame
4 weeks
Title
Behavior
Description
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)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Others
Description
Biological data (potassium, transaminases), weight in kilogrammes and body mass index (kg/m2)
Time Frame
4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women Hospitalized Anorexia nervosa Body mass index (kg/m2) < 16 Exclusion Criteria: Men
Facility Information:
Facility Name
University Hospital Reina Sofía
City
Murcia
ZIP/Postal Code
30003
Country
Spain

12. IPD Sharing Statement

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Anorexia Nervosa Inpatient Physiotherapy Adapted Program

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