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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
120
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).
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
Stockholms Sjukhem
Stockholm, Sweden
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
Time frame: 12 weeks
Functional balance
Bergs Balance Scale
Time frame: 12 weeks
Walking ability
walking propulsion indoors for a distance of 10 m at self-selected speed
Time frame: 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
Time frame: 12 weeks
Nutritional status
Mini Nutritional Assessment,
Time frame: 12 weeks
Body composition
bioelectrical impedance analysis
Time frame: 12 weeks
Blood Chemistry - albumin
plasma albumin
Time frame: 12 weeks
Blood Chemistry - transthyretin
plasma transthyretin
Time frame: 12 weeks
Blood Chemistry - CRP
plasma C-reactive protein (CRP)
Time frame: 12 weeks
Blood Chemistry - IGF-1
The anabolic mediator plasma insuline-like growth factor-1 (IGF-I)
Time frame: 12 weeks
Blood Chemistry - S-25 vit D
D-vitamin status will be assessed by S-25 (OH) vitamin D
Time frame: 12 weeks
Blood Chemistry - creatinin
Plasma creatinin
Time frame: 12 weeks
Blood Chemistry - Cystatin C
Plasma-Cystatin C
Time frame: 12 weeks
Quality of Life
EQ-5D, the Euroqool instrument
Time frame: 12 weeks
Healthcare Resource Use - hospitalisations
hospitalisations
Time frame: 12 weeks
Healthcare Resource Use - length of stay
length of stay at hospital
Time frame: 12 weeks
Healthcare Resource Use - number of visits
the number of visits to healthcare professionals (both as outpatients and as a home visit
Time frame: 12 weeks
Healthcare Resource Use - time of staff
the time of the staff (nursing aides) in the training and implementation of the intervention
Time frame: 12 weeks
Medical incidences - fall
frequency and incidence of falls
Time frame: 12 weeks
Medical incidences - pressure ulcers
frequency and incidence of pressure ulcers
Time frame: 12 weeks
Medical incidences - infections
frequency and incidence of infections
Time frame: 12 weeks
Medical incidences - incontinence
frequency and incidence of incontinence
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.