Older Person's Exercise and Nutrition Study (OPEN)

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

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 Overview

• Status: Completed
• Conditions: Malnutrition; Mobility Limitations
• Intervention / Treatment: Dietary supplement: oral protein-rich supplement; Other: Exercise

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Stockholms sjukhem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard care
Experimental: Intervention; 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; 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).; Other: Exercise; 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; Other Names: Sit-to-stand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Nutricia Foundation
• Investigators: Principal Investigator: Anne-Marie Bostrom, PhD, Karolinska Institutet

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): December 11, 2017
• Study Completion (Actual): December 11, 2017

Study Registration Dates

• First Submitted: February 26, 2016
• First Submitted That Met QC Criteria: March 2, 2016
• First Posted (Estimate): March 8, 2016

Study Record Updates

• Last Update Posted (Actual): April 26, 2019
• Last Update Submitted That Met QC Criteria: April 25, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Mobility Limitation
• Other Study ID Numbers: ISS.FinGrant_Fortimel_2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No