Clinical trial NCT02702037: Older Person's Exercise and Nutrition Study
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
Overall status: COMPLETED
Phase: NA
Conditions: Mobility Limitations
Malnutrition
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Nutricia Foundation
First posted: 2016-03-08
Enrollment: 120
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: 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
timeFrame: 12 weeks
Secondary outcomes:
measure: Functional balance
timeFrame: 12 weeks
measure: Walking ability
timeFrame: 12 weeks
measure: Everyday activities and function
timeFrame: 12 weeks
measure: Nutritional status
timeFrame: 12 weeks
measure: Body composition
timeFrame: 12 weeks
measure: Blood Chemistry - albumin
timeFrame: 12 weeks
measure: Blood Chemistry - transthyretin
timeFrame: 12 weeks
measure: Blood Chemistry - CRP
timeFrame: 12 weeks
measure: Blood Chemistry - IGF-1
timeFrame: 12 weeks
measure: Blood Chemistry - S-25 vit D
timeFrame: 12 weeks
measure: Blood Chemistry - creatinin
timeFrame: 12 weeks
measure: Blood Chemistry - Cystatin C
timeFrame: 12 weeks
measure: Quality of Life
timeFrame: 12 weeks
measure: Healthcare Resource Use - hospitalisations
timeFrame: 12 weeks
measure: Healthcare Resource Use - length of stay
timeFrame: 12 weeks
measure: Healthcare Resource Use - number of visits
timeFrame: 12 weeks
measure: Healthcare Resource Use - time of staff
timeFrame: 12 weeks
measure: Medical incidences - fall
timeFrame: 12 weeks
measure: Medical incidences - pressure ulcers
timeFrame: 12 weeks
measure: Medical incidences - infections
timeFrame: 12 weeks
measure: Medical incidences - incontinence
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Stockholms Sjukhem
Study officials:
affiliation: Karolinska Institutet
name: Anne-Marie Bostrom, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.