Older Person's Exercise and Nutrition Study

Not Applicable

Completed

• Conditions: Mobility Limitations; Malnutrition
• Interventions: Dietary Supplement: oral protein-rich supplement; Other: Exercise

• Registration Number: NCT02702037
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2016-02-26
• Study Start: 2016-03-01
• Study First Submitted QC: 2016-03-02
• Study First Posted: 2016-03-08
• Primary Completion: 2017-12-11
• Study Completion: 2017-12-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-25
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Read More

Exclusion Criteria

• BMI >30
• severe dysphagia,
• tube feeding,
• severe kidney failure,
• bedridden people,
• terminal stage of life
• Lack of informed consent.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	oral protein-rich supplement	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).
Intervention	Exercise	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).

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Stockholms Sjukhem; 🇸🇪 Stockholm, Sweden