Older Person's Exercise and Nutrition Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Mobility Limitations, Malnutrition

Intervention / Treatment
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* Dietary Supplement: oral protein-rich supplement
* Other: Exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The participants will be supported to perform the sit-to-stand exercise at least four times per day during 12 weeks (7 days/week). The participants will also 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). | Dietary Supplement: oral protein-rich supplement<br>* 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).<br>Other: Exercise<br>* 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<br>* Other names: Sit-to-stand;|
| No Intervention: Control<br>Standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional balance | Bergs Balance Scale | 12 weeks | 
| Walking ability | walking propulsion indoors for a distance of 10 m at self-selected speed | 12 weeks | 
| 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 | 
| Nutritional status | Mini Nutritional Assessment, | 12 weeks | 
| Body composition | bioelectrical impedance analysis | 12 weeks | 
| Blood Chemistry - albumin | plasma albumin | 12 weeks | 
| Blood Chemistry - transthyretin | plasma transthyretin | 12 weeks | 
| Blood Chemistry - CRP | plasma C-reactive protein (CRP) | 12 weeks | 
| Blood Chemistry - IGF-1 | The anabolic mediator plasma insuline-like growth factor-1 (IGF-I) | 12 weeks | 
| Blood Chemistry - S-25 vit D | D-vitamin status will be assessed by S-25 (OH) vitamin D | 12 weeks | 
| Blood Chemistry - creatinin | Plasma creatinin | 12 weeks | 
| Blood Chemistry - Cystatin C | Plasma-Cystatin C | 12 weeks | 
| Quality of Life | EQ-5D, the Euroqool instrument | 12 weeks | 
| Healthcare Resource Use - hospitalisations | hospitalisations | 12 weeks | 
| Healthcare Resource Use - length of stay | length of stay at hospital | 12 weeks | 
| Healthcare Resource Use - number of visits | the number of visits to healthcare professionals (both as outpatients and as a home visit | 12 weeks | 
| Healthcare Resource Use - time of staff | the time of the staff (nursing aides) in the training and implementation of the intervention | 12 weeks | 
| Medical incidences - fall | frequency and incidence of falls | 12 weeks | 
| Medical incidences - pressure ulcers | frequency and incidence of pressure ulcers | 12 weeks | 
| Medical incidences - infections | frequency and incidence of infections | 12 weeks | 
| Medical incidences - incontinence | frequency and incidence of incontinence | 12 weeks |