Clinical and Medico-economic Evaluation of Taken Care Associating Nutritional Support and Adapted Physical Activity for Malnourished, or at Risk of Undernutrition, Elderly People on Discharge From Hospital

NCT03979560 | Terminated DMC

• 1 other identifier: 2017-A02973-50
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

In the hospital, one out of every two elderly people is malnourished. This condition of undernutrition generally worsens during hospitalization, where the effects of polypathology and psychological distress are added. Muscle loss due to inadequate dietary intake, hypermetabolism and immobilization results in the onset or worsening of mobility disorders and functional decline. After hospitalization, 30-50% of elderly people hospitalized in emergency in medical departments have lost autonomy in daily life. Nutritional management and adaptive physical activity (APA) could have synergistic action to improve the nutritional status and mobility of elderly patients. The short duration of the average stay the acute geriatric units (10-15 days) is not enough to renew, nor to re-educate patients. It seems important to continue these actions at home. The implementation of programs combining nutrition and adapted physical activity (APA) at the hospital exit has not been studied to date. We formulate the hypothesis that in elderly people who are malnourished or at risk of undernutrition, after hospitalization, a personalized home intervention combining nutritional advice and appropriate physical activity will limit their loss of autonomy.

Conditions

Under-nutrition or Risk of Undernutrition

Keywords

Autonomy; Nutritional support; Adapted physical activity; Undernutrition; Older people; Hospital discharge; Under-nutrition

Outcome Measures

Primary Outcomes (1)

• Assessment of level of autonomy according Activities of Daily Living (ADL) score

  To assess the effect of taken care associating nutritional support and adapted physical activity (APA) on the independence of elderly people who are malnourished or at risk of malnutrition at the end of their stay in hospital.

  18 months

Secondary Outcomes (6)

• Assessment of of dependency according Gerontological autonomy group iso-resources (AGGIR ) score

  18 mois

• Assessment of undernutrition according Mini Nutritional Assessment (MNA)

  18 months

• Assessment of gait, balance and muscle according Short Physical Performance Battery (SPPB) score

  18 months

• Measuring quality of life according EuroQol- 5 Dimension (EQ-5D) scale

  18 months

• Assessment of comorbidity according Cumulative Illness Rating Scale-Geriatric (CIRS-G) scale

  18 months

Study Arms (2)

Control

NO INTERVENTION

The control group will benefit from the usual support (depending on the practices of the department, prescription or not of oral nutritional supplements and physiotherapy at home, but without home intervention of adapted physical activity professionals or dieticians). In addition to screening/inclusion visits (D0), three follow-up home visits are scheduled at D7, D45 and D90 for both study groups.

Nutrition intervention with appropriate physical activity

EXPERIMENTAL

Intervention at home of professionals: Patients in this arm will benefit from 14 home interventions * 7 home nutrition support (NS) sessions in 3 months or 1 session every 10 days (+/-4 days). These sessions will be conducted by a dietician from the company "Saveurs et Vie". * 7 home sessions of adaptive physical activity (APA) in 3 months, one session every 10 days (+/-4 days). These sessions will be conducted by professionals from association group "Siel Bleu". In addition to screening/inclusion visits (D0), three follow-up home visits are scheduled at D7, D45 and D90 for both study groups.

Other: Intervention

Interventions

Intervention OTHER

Nutritional support in seven sessions spread over three months, combined with an adapted physical activity intervention (APA), also at a frequency of seven sessions spread over three months, or fourteen home sessions.

Nutrition intervention with appropriate physical activity

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Men or women aged at least 70
• Hospitalized in acute geriatrics (UGA), with expected return to home directly after the UGA
• Undernourished or at risk of undernutrition (MNA SF12)
• Able to walk 4 metres without third party assistance
• Able to understand and consent to the study
• Good understanding of the French language
• Living in Paris (department 75)
• Patient affiliated with a social security scheme
• Having read the information note and having agreed to participate in the study by signing the consent.

You may not qualify if:

• Life expectancy less than 6 months
• Chronic inflammatory pathology
• Progressive cancer
• Severe renal failure (creatinine clearance \< 30ml/min/1.73 m2)
• NYHA Stage III or IV Dyspnea
• Chronic respiratory failure (oxygen therapy at home)
• Liver failure (TP \< 50%)
• Severe depression
• severe dementia, according to DSM V criteria
• swallowing disorders with inhalation pneumonia
• corticosteroids (\> 10 mg prednisone/day long-term or equivalent)
• Systolic blood pressure \>200 mmHg
• Unstabilized acute coronary syndrome
• decompensated heart failure
• Severe, uncontrolled ventricular rhythm disorders

Sponsors & Collaborators

• Gérond'if: lead

Study Sites (1)

Département de Gériatrie, Hôpital Bichat

Paris, Île-de-France Region, 75018, France

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Methods

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: June 7, 2019
• Study Start: June 28, 2019
• Primary Completion: June 17, 2021
• Study Completion: December 23, 2021
• Last Updated: February 2, 2023

Record last verified: 2023-01

Locations

FR (1)