Older Person's Exercise and Nutrition Study

Malnutrition Clinical Trial

— OPEN  

Official title:

Older Person's Exercise and Nutrition Study (OPEN): a Simple Physical Exercise Combined With Protein Supplement - Effects on Functional Status and Independence Among Older People: A Cluster Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702037
• Other study ID #: ISS.FinGrant_Fortimel_2015
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: December 11, 2017

Study information

• Verified date: April 2019
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The novelty with the OPEN study is to evaluate the effects of the simple sit-to-stand exercise during routine care, in combination with an oral protein-rich supplement, on functional status and independence in frail older persons. In this study we will also explore the experiences among older persons in the intervention group as wells as among staff of promoting the sit-to-stand exercise and nutritional supplement to gain knowledge for implementation as a daily routine in nursing homes across Sweden.

Hypothesis The main hypothesis of the OPEN study is that physical exercise performed as a daily routine along with an oral protein-rich supplement, will result in improved functional status and independence in everyday life activities and thereby enhance health-related quality of life in older persons living in nursing homes. The primary outcome measure for functional status will be the number of sit-to-stands that the participant is able to complete in 30 seconds.

Specific aims Aim I: To study the effects of the sit-to-stand exercise combined with an oral protein-rich supplement on functional and nutritional status, and health-related quality of life, and the frequency and incidence of falls, pressure ulcers and incontinence in older persons living in nursing homes. Furthermore, the cost effectiveness of the combination of the sit to stand exercise and oral protein-rich supplement vs. the control group will also be examined.

Aim II: To describe the older persons' perceptions of daily being offered to conduct the sit-to-stand exercise and to drink the nutritional supplement.

Aim III: To describe staff's perceptions of supporting the sit-to-stand exercise and the nutritional supplement with older persons living in nursing homes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 11, 2017
• Est. primary completion date: December 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Able to rise independently from a seated position to standing-

Exclusion Criteria:

• BMI >30

• severe dysphagia,

• tube feeding,

• severe kidney failure,

• bedridden people,

• terminal stage of life

• Lack of informed consent.

Related Conditions & MeSH terms

• Malnutrition
• Mobility Limitation
• Mobility Limitations

Intervention

Dietary Supplement:
• oral protein-rich supplement
The older person will be offered an oral protein-rich supplement (125 ml, 18 g protein (24% of RDI), 300 kcal) twice a day in conjunction with two of the four sit-to-stand exercises during 12 weeks (7 days/week).

Other:
• Exercise
The older person will get up from a chair to stand and then sit down again repeatedly at least four times per day, 7 days during 12 weeks

Locations

Country	Name	City	State
Sweden	Stockholms Sjukhem	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Nutricia Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure for functional status will be the number of sit-to-stands that the participant is able to complete in 30 seconds		12 weeks
Secondary	Functional balance	Bergs Balance Scale	12 weeks
Secondary	Walking ability	walking propulsion indoors for a distance of 10 m at self-selected speed	12 weeks
Secondary	Everyday activities and function	Functional Independence Measure (FIM) which comprises 18 items grouped in the following functional domains: bathing, bowel management, toileting, eating, dressing lower body and social interaction. It is scored on a 7-point scale from 1 (dependent) to 7 (independent). 29. Cohen ME & Marino RJ. The tools of disability outcomes research functional status measures. Arch Phys Med Rehabil 2000;81:21-29	12 weeks
Secondary	Nutritional status	Mini Nutritional Assessment,	12 weeks
Secondary	Body composition	bioelectrical impedance analysis	12 weeks
Secondary	Blood Chemistry - albumin	plasma albumin	12 weeks
Secondary	Blood Chemistry - transthyretin	plasma transthyretin	12 weeks
Secondary	Blood Chemistry - CRP	plasma C-reactive protein (CRP)	12 weeks
Secondary	Blood Chemistry - IGF-1	The anabolic mediator plasma insuline-like growth factor-1 (IGF-I)	12 weeks
Secondary	Blood Chemistry - S-25 vit D	D-vitamin status will be assessed by S-25 (OH) vitamin D	12 weeks
Secondary	Blood Chemistry - creatinin	Plasma creatinin	12 weeks
Secondary	Blood Chemistry - Cystatin C	Plasma-Cystatin C	12 weeks
Secondary	Quality of Life	EQ-5D, the Euroqool instrument	12 weeks
Secondary	Healthcare Resource Use - hospitalisations	hospitalisations	12 weeks
Secondary	Healthcare Resource Use - length of stay	length of stay at hospital	12 weeks
Secondary	Healthcare Resource Use - number of visits	the number of visits to healthcare professionals (both as outpatients and as a home visit	12 weeks
Secondary	Healthcare Resource Use - time of staff	the time of the staff (nursing aides) in the training and implementation of the intervention	12 weeks
Secondary	Medical incidences - fall	frequency and incidence of falls	12 weeks
Secondary	Medical incidences - pressure ulcers	frequency and incidence of pressure ulcers	12 weeks
Secondary	Medical incidences - infections	frequency and incidence of infections	12 weeks
Secondary	Medical incidences - incontinence	frequency and incidence of incontinence	12 weeks