Anorexia NervosaPhase 4ANIPAPNCT04190290
Anorexia Nervosa Inpatient Physiotherapy Adapted Program
A Phase 4 study testing Physiotherapy Adapted Program in people with Anorexia Nervosa, run by Universidad de Murcia at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Physiotherapy Adapted Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 11 Apr 2018to 1 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women
- Hospitalized
- Anorexia nervosa
- Body mass index (kg/m2) < 16
Who cannot join
- Men
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anorexia Nervosa
- Being tested
- Physiotherapy Adapted Program, Evaluation and Control
- Keywords
- Anorexia nervosa, Muscle strength, Peak-expiratory-flow, Quality of life
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy Adapted ProgramOther
Also called Adapted exercises
3 days / week mobilisations and respiratory exercises and body image exercises
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Mobilizations and exercises training Respiratory exercises Body image exercises Receives: Other: Physiotherapy Adapted Program; Diagnostic Test: Evaluation and Control |
| Control | Active comparator | Muscle strength evaluation and Eating behavior evaluation and Quality of life Receives: Diagnostic Test: Evaluation and Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Resistance
Cardiopulmonary function with six minute walking test. Calculate the distance walked in 6 minutes in metres.
Measured: 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).
Measured: 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)
Measured: 4 weeks
Secondary outcomes (1)
Others
Biological data (potassium, transaminases), weight in kilogrammes and body mass index (kg/m2)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start11 Apr 2018
- Primary completion15 Jan 2021
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Quasi experimental prospective study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilio José Miñano Garrido, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190290
- Sponsor's protocol ID
- UMU
- Acronym
- ANIPAP
- Status last verified
- May 2022
- First submitted
- 22 Nov 2019
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Minano-Garrido E, Catalan-Matamoros D, Acosta GP, Gomez-Conesa A. The effect of anorexia nervosa inpatient physiotherapy adapted program (ANIPAP): A clinical trial. J Bodyw Mov Ther. 2025 Jun;42:337-343. doi: 10.1016/j.jbmt.2024.12.043. Epub 2024 Dec 27.
PubMed 40325688
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adapted Program of Physiotherapy in Hospitalized Person by Anorexia Nervosa With Several Undernutrition
- ClinicalTrials.gov ID
- NCT04190290
- Acronym / sponsor ID
- ANIPAP / UMU
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia nervosa, Muscle strength, Peak-expiratory-flow, Quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Quasi experimental prospective study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Physiotherapy Adapted Program, Diagnostic Test: Evaluation and ControlMobilizations and exercises training Respiratory exercises Body image exercises |
| Control | Active comparator | Diagnostic Test: Evaluation and ControlMuscle strength evaluation and Eating behavior evaluation and Quality of life |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Women
- Hospitalized
- Anorexia nervosa
- Body mass index (kg/m2) < 16
Key exclusion criteria (1 listed)
- Men
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy Adapted ProgramAlso: Adapted exercises3 days / week mobilisations and respiratory exercises and body image exercises | Other | Intervention |
| Evaluation and ControlManual muscle test MRC score, peak-expiratory-flow test, hand strength test, 6 minutes walking test, SF-36, EDI-3 and EDQOL | Diagnostic test | Control, Intervention |
Primary outcome
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
Resistance
Time frame: 4 weeks
Cardiopulmonary function with six minute walking test. Calculate the distance walked in 6 minutes in metres.
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).
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)
1 secondary outcome
Others
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Derived from this study: PubMed 40325688Minano-Garrido E, Catalan-Matamoros D, Acosta GP, Gomez-Conesa A. The effect of anorexia nervosa inpatient physiotherapy adapted program (ANIPAP): A clinical trial. J Bodyw Mov Ther. 2025 Jun;42:337-343. doi: 10.1016/j.jbmt.2024.12.043. Epub 2024 Dec 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Physiotherapy Adapted Program in people with Anorexia Nervosa, run by Universidad de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04190290, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.