Older Person's Exercise and Nutrition Study

NCT02702037 | Completed

• 1 other identifier: ISS.FinGrant_Fortimel_2015
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Mobility Limitations; Malnutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Functional balance

  12 weeks

• Walking ability

  12 weeks

• Everyday activities and function

  12 weeks

• Nutritional status

  12 weeks

• Body composition

  12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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; Other: Exercise

Control

NO INTERVENTION

Standard care

Interventions

oral protein-rich supplement DIETARY_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).

Intervention

Exercise OTHER

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

Also known as: Sit-to-stand

Intervention

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Nutricia Foundation: collaborator

Study Sites (1)

Stockholms Sjukhem

Stockholm, Sweden

Location

Related Publications (4)

• 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.

  PMID: 33546610 DERIVED

• 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.

  PMID: 32887570 DERIVED

• 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.

  PMID: 32471657 DERIVED

• 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.

  PMID: 29898671 DERIVED

MeSH Terms

Conditions

Mobility Limitation; Malnutrition

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anne-Marie Bostrom, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Senior Lecturer

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: March 8, 2016
• Study Start: March 1, 2016
• Primary Completion: December 11, 2017
• Study Completion: December 11, 2017
• Last Updated: April 26, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)