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Mobility LimitationsOPENNCT02702037

Older Person's Exercise and Nutrition Study

A study testing oral protein-rich supplement and Exercise in people with Mobility Limitations and Malnutrition, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Mobility Limitations, Malnutrition
What is being tested?
oral protein-rich supplement and Exercise
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSweden
Study dates
1 Mar 2016to 11 Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Stockholms Sjukhem

    Stockholm

Other trials in Sweden

About this 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

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.

Read more

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.

Being tested
oral protein-rich supplement, Exercise
Medical subject headings
Mobility Limitation, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oral protein-rich supplementDietary 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).

  • ExerciseOther

    Also called Sit-to-stand

    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

Study groups in NCT02702037
Study groupRoleWhat they receive
InterventionExperimentalThe 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).
Receives: Dietary Supplement: oral protein-rich supplement; Other: Exercise
ControlNo interventionStandard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 weeks

Secondary outcomes (21)

  1. Functional balance

    Bergs Balance Scale

    Measured: 12 weeks

  2. Walking ability

    walking propulsion indoors for a distance of 10 m at self-selected speed

    Measured: 12 weeks

  3. 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

    Measured: 12 weeks

  4. Nutritional status

    Mini Nutritional Assessment,

    Measured: 12 weeks

  5. Body composition

    bioelectrical impedance analysis

    Measured: 12 weeks

  6. Blood Chemistry - albumin

    plasma albumin

    Measured: 12 weeks

  7. Blood Chemistry - transthyretin

    plasma transthyretin

    Measured: 12 weeks

  8. Blood Chemistry - CRP

    plasma C-reactive protein (CRP)

    Measured: 12 weeks

  9. Blood Chemistry - IGF-1

    The anabolic mediator plasma insuline-like growth factor-1 (IGF-I)

    Measured: 12 weeks

  10. Blood Chemistry - S-25 vit D

    D-vitamin status will be assessed by S-25 (OH) vitamin D

    Measured: 12 weeks

  11. Blood Chemistry - creatinin

    Plasma creatinin

    Measured: 12 weeks

  12. Blood Chemistry - Cystatin C

    Plasma-Cystatin C

    Measured: 12 weeks

  13. Quality of Life

    EQ-5D, the Euroqool instrument

    Measured: 12 weeks

  14. Healthcare Resource Use - hospitalisations

    hospitalisations

    Measured: 12 weeks

  15. Healthcare Resource Use - length of stay

    length of stay at hospital

    Measured: 12 weeks

  16. Healthcare Resource Use - number of visits

    the number of visits to healthcare professionals (both as outpatients and as a home visit

    Measured: 12 weeks

  17. Healthcare Resource Use - time of staff

    the time of the staff (nursing aides) in the training and implementation of the intervention

    Measured: 12 weeks

  18. Medical incidences - fall

    frequency and incidence of falls

    Measured: 12 weeks

  19. Medical incidences - pressure ulcers

    frequency and incidence of pressure ulcers

    Measured: 12 weeks

  20. Medical incidences - infections

    frequency and incidence of infections

    Measured: 12 weeks

  21. Medical incidences - incontinence

    frequency and incidence of incontinence

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2016 (estimated)
  2. Study start1 Mar 2016
  3. Primary completion11 Dec 2017
  4. Study completion11 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02702037
Sponsor's protocol ID
ISS.FinGrant_Fortimel_2015
Acronym
OPEN
Status last verified
Apr 2019
First submitted
26 Feb 2016
Last updated
26 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wimo A, Cederholm T, Irving GF, Franzen E, Gronstedt H, Seiger A, Vikstrom S, Bostrom AM. Impact of an exercise and nutrition program on caregiver time with residents in institutional care-A secondary analysis. Alzheimers Dement. 2026 Feb;22(2):e71198. doi: 10.1002/alz.71198.

    PubMed 41690799

  • 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.

    PubMed 33546610

  • 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.

    PubMed 32887570

  • 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.

    PubMed 32471657

  • 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.

    PubMed 29898671

Questions about this trial

What is this clinical trial studying?

A study testing oral protein-rich supplement and Exercise in people with Mobility Limitations and Malnutrition, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02702037, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.

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