ANIPAP: Anorexia Nervosa Inpatient Physiotherapy Adapted Program

Sponsor

Universidad de Murcia (Other)

Overall Status

Completed

CT.gov ID

NCT04190290

Collaborator

(none)

Enrollment

Location

Arms

48.7

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Nervosa	Other: Physiotherapy Adapted Program Diagnostic Test: Evaluation and Control	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Quasi experimental prospective studyQuasi experimental prospective study

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Randomized group

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 11, 2018

Actual Primary Completion Date :

Jan 15, 2021

Actual Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Mobilizations and exercises training Respiratory exercises Body image exercises	Other: Physiotherapy Adapted Program 3 days / week mobilisations and respiratory exercises and body image exercises Other Names: Adapted 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
Active Comparator: Control Muscle strength evaluation and Eating behavior evaluation and Quality of life	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

Arm

Intervention/Treatment

Experimental: Intervention

Mobilizations and exercises training Respiratory exercises Body image exercises

Other: Physiotherapy Adapted Program

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

Other Names:

Adapted 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

Active Comparator: Control

Muscle strength evaluation and Eating behavior evaluation and Quality of life

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

Outcome Measures

Primary Outcome Measures

Strength [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
Resistance [4 weeks]
Cardiopulmonary function with six minute walking test. Calculate the distance walked in 6 minutes in metres.
Life [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).
Behavior [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 Outcome Measures

Others [4 weeks]
Biological data (potassium, transaminases), weight in kilogrammes and body mass index (kg/m2)

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Reina Sofía	Murcia		Spain	30003

Sponsors and Collaborators

Universidad de Murcia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Emilio José Miñano Garrido, Principal Investigator, Universidad de Murcia

ClinicalTrials.gov Identifier:

NCT04190290

Other Study ID Numbers:

First Posted:

Dec 9, 2019

Last Update Posted:

May 23, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Emilio José Miñano Garrido, Principal Investigator, Universidad de Murcia

Additional relevant MeSH terms:

Anorexia

Anorexia Nervosa

Study Results

No Results Posted as of May 23, 2022