NCT04190290

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 9, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

2.8 years

First QC Date

November 22, 2019

Last Update Submit

May 16, 2022

Conditions

Anorexia Nervosa

Keywords

Anorexia nervosaMuscle strengthPeak-expiratory-flowQuality of life

Outcome Measures

Primary Outcomes (4)

  • 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

  • Resistance

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

    4 weeks

  • 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

  • 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 Outcomes (1)

  • Others

    4 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Mobilizations and exercises training Respiratory exercises Body image exercises

Other: Physiotherapy Adapted ProgramDiagnostic Test: Evaluation and Control

Control

ACTIVE COMPARATOR

Muscle strength evaluation and Eating behavior evaluation and Quality of life

Diagnostic Test: Evaluation and Control

Interventions

Physiotherapy Adapted ProgramOTHER

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

Also known as: Adapted exercises
Intervention
Evaluation and ControlDIAGNOSTIC_TEST

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

ControlIntervention

Eligibility Criteria

Age12 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Men

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Reina Sofía

Murcia, 30003, Spain

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Randomized group
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Quasi experimental prospective study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 22, 2019

First Posted

December 9, 2019

Study Start

April 11, 2018

Primary Completion

January 15, 2021

Study Completion

May 1, 2022

Last Updated

May 23, 2022

Record last verified: 2022-05

Locations

ES(1)