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OpenTrials
Completed

NCT Number: NCT02702037

Older Person's Exercise and Nutrition Study

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.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stockholms Sjukhem

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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

Other names: Sit-to-stand

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

    Time frame: 12 weeks

Secondary outcomes

  1. Functional balance

    Time frame: 12 weeks

    Bergs Balance Scale

  2. Walking ability

    Time frame: 12 weeks

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

  3. Everyday activities and function

    Time frame: 12 weeks

    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

  4. Nutritional status

    Time frame: 12 weeks

    Mini Nutritional Assessment,

  5. Body composition

    Time frame: 12 weeks

    bioelectrical impedance analysis

  6. Blood Chemistry - albumin

    Time frame: 12 weeks

    plasma albumin

  7. Blood Chemistry - transthyretin

    Time frame: 12 weeks

    plasma transthyretin

  8. Blood Chemistry - CRP

    Time frame: 12 weeks

    plasma C-reactive protein (CRP)

  9. Blood Chemistry - IGF-1

    Time frame: 12 weeks

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

  10. Blood Chemistry - S-25 vit D

    Time frame: 12 weeks

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

  11. Blood Chemistry - creatinin

    Time frame: 12 weeks

    Plasma creatinin

  12. Blood Chemistry - Cystatin C

    Time frame: 12 weeks

    Plasma-Cystatin C

  13. Quality of Life

    Time frame: 12 weeks

    EQ-5D, the Euroqool instrument

  14. Healthcare Resource Use - hospitalisations

    Time frame: 12 weeks

    hospitalisations

  15. Healthcare Resource Use - length of stay

    Time frame: 12 weeks

    length of stay at hospital

  16. Healthcare Resource Use - number of visits

    Time frame: 12 weeks

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

  17. Healthcare Resource Use - time of staff

    Time frame: 12 weeks

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

  18. Medical incidences - fall

    Time frame: 12 weeks

    frequency and incidence of falls

  19. Medical incidences - pressure ulcers

    Time frame: 12 weeks

    frequency and incidence of pressure ulcers

  20. Medical incidences - infections

    Time frame: 12 weeks

    frequency and incidence of infections

  21. Medical incidences - incontinence

    Time frame: 12 weeks

    frequency and incidence of incontinence

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Nutricia Foundation

Registry information

Official study 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

Acronym: OPEN

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 8, 2016
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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