Older Person's Exercise and Nutrition Study (OPEN)
Primary Purpose
Mobility Limitations, Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
oral protein-rich supplement
Exercise
Sponsored by
About this trial
This is an interventional prevention trial for Mobility Limitations
Eligibility Criteria
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.
Sites / Locations
- Stockholms Sjukhem
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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).
Standard care
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Functional balance
Bergs Balance Scale
Walking ability
walking propulsion indoors for a distance of 10 m at self-selected speed
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
Nutritional status
Mini Nutritional Assessment,
Body composition
bioelectrical impedance analysis
Blood Chemistry - albumin
plasma albumin
Blood Chemistry - transthyretin
plasma transthyretin
Blood Chemistry - CRP
plasma C-reactive protein (CRP)
Blood Chemistry - IGF-1
The anabolic mediator plasma insuline-like growth factor-1 (IGF-I)
Blood Chemistry - S-25 vit D
D-vitamin status will be assessed by S-25 (OH) vitamin D
Blood Chemistry - creatinin
Plasma creatinin
Blood Chemistry - Cystatin C
Plasma-Cystatin C
Quality of Life
EQ-5D, the Euroqool instrument
Healthcare Resource Use - hospitalisations
hospitalisations
Healthcare Resource Use - length of stay
length of stay at hospital
Healthcare Resource Use - number of visits
the number of visits to healthcare professionals (both as outpatients and as a home visit
Healthcare Resource Use - time of staff
the time of the staff (nursing aides) in the training and implementation of the intervention
Medical incidences - fall
frequency and incidence of falls
Medical incidences - pressure ulcers
frequency and incidence of pressure ulcers
Medical incidences - infections
frequency and incidence of infections
Medical incidences - incontinence
frequency and incidence of incontinence
Full Information
NCT ID
NCT02702037
First Posted
February 26, 2016
Last Updated
April 25, 2019
Sponsor
Karolinska Institutet
Collaborators
Nutricia Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02702037
Brief Title
Older Person's Exercise and Nutrition Study
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
December 11, 2017 (Actual)
Study Completion Date
December 11, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Nutricia Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitations, Malnutrition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Dietary Supplement
Intervention Name(s)
oral protein-rich supplement
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Exercise
Other Intervention Name(s)
Sit-to-stand
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Functional balance
Description
Bergs Balance Scale
Time Frame
12 weeks
Title
Walking ability
Description
walking propulsion indoors for a distance of 10 m at self-selected speed
Time Frame
12 weeks
Title
Everyday activities and function
Description
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
Title
Nutritional status
Description
Mini Nutritional Assessment,
Time Frame
12 weeks
Title
Body composition
Description
bioelectrical impedance analysis
Time Frame
12 weeks
Title
Blood Chemistry - albumin
Description
plasma albumin
Time Frame
12 weeks
Title
Blood Chemistry - transthyretin
Description
plasma transthyretin
Time Frame
12 weeks
Title
Blood Chemistry - CRP
Description
plasma C-reactive protein (CRP)
Time Frame
12 weeks
Title
Blood Chemistry - IGF-1
Description
The anabolic mediator plasma insuline-like growth factor-1 (IGF-I)
Time Frame
12 weeks
Title
Blood Chemistry - S-25 vit D
Description
D-vitamin status will be assessed by S-25 (OH) vitamin D
Time Frame
12 weeks
Title
Blood Chemistry - creatinin
Description
Plasma creatinin
Time Frame
12 weeks
Title
Blood Chemistry - Cystatin C
Description
Plasma-Cystatin C
Time Frame
12 weeks
Title
Quality of Life
Description
EQ-5D, the Euroqool instrument
Time Frame
12 weeks
Title
Healthcare Resource Use - hospitalisations
Description
hospitalisations
Time Frame
12 weeks
Title
Healthcare Resource Use - length of stay
Description
length of stay at hospital
Time Frame
12 weeks
Title
Healthcare Resource Use - number of visits
Description
the number of visits to healthcare professionals (both as outpatients and as a home visit
Time Frame
12 weeks
Title
Healthcare Resource Use - time of staff
Description
the time of the staff (nursing aides) in the training and implementation of the intervention
Time Frame
12 weeks
Title
Medical incidences - fall
Description
frequency and incidence of falls
Time Frame
12 weeks
Title
Medical incidences - pressure ulcers
Description
frequency and incidence of pressure ulcers
Time Frame
12 weeks
Title
Medical incidences - infections
Description
frequency and incidence of infections
Time Frame
12 weeks
Title
Medical incidences - incontinence
Description
frequency and incidence of incontinence
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Marie Bostrom, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stockholms Sjukhem
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33546610
Citation
Vikstrom S, Gronstedt HK, Cederholm T, Franzen E, Faxen-Irving G, Seiger A, Bostrom AM. Experiences of supporting older persons in completion of an exercise and nutrition intervention: an interview study with nursing home staff. BMC Geriatr. 2021 Feb 5;21(1):109. doi: 10.1186/s12877-021-02039-7.
Results Reference
derived
PubMed Identifier
32887570
Citation
Vikstrom S, Gronstedt HK, Cederholm T, Franzen E, Seiger A, Faxen-Irving G, Bostrom AM. A health concept with a social potential: an interview study with nursing home residents. BMC Geriatr. 2020 Sep 4;20(1):324. doi: 10.1186/s12877-020-01731-4.
Results Reference
derived
PubMed Identifier
32471657
Citation
Gronstedt H, Vikstrom S, Cederholm T, Franzen E, Luiking YC, Seiger A, Wimo A, Faxen-Irving G, Bostrom AM. Effect of Sit-to-Stand Exercises Combined With Protein-Rich Oral Supplementation in Older Persons: The Older Person's Exercise and Nutrition Study. J Am Med Dir Assoc. 2020 Sep;21(9):1229-1237. doi: 10.1016/j.jamda.2020.03.030. Epub 2020 May 26.
Results Reference
derived
PubMed Identifier
29898671
Citation
Gronstedt H, Vikstrom S, Cederholm T, Franzen E, Seiger A, Wimo A, Faxen-Irving G, Bostrom AM. A study protocol of Older Person's Exercise and Nutrition Study (OPEN) - a sit-to-stand activity combined with oral protein supplement - effects on physical function and independence: a cluster randomized clinical trial. BMC Geriatr. 2018 Jun 7;18(1):138. doi: 10.1186/s12877-018-0824-1.
Results Reference
derived
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Older Person's Exercise and Nutrition Study
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