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Telerehabilitation in Geriatric Patients at Aarhus University Hospital, Denmark

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ClinicalTrials.gov Identifier: NCT03952858
Recruitment Status : Active, not recruiting
First Posted : May 16, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

Background Older patients admitted to an Emergency Department (ED) are dependent on assistive devices and almost 16 % have no gait function. It seems appropriate to identify patients who need physical exercises immediately after discharge to avoid further functional decline. New IT technologies make it possible to both supervise the exercises and communicate with the patients via video conferencing equipment. Until now no studies have examined if the Otago Exercise Program (OEP) supervised by video conferencing may enhance motivation and maintain or improve physical functional capacity in acute elderly patients.

Hypothesis Early telerehabilitation performed in groups based on the OEP is compared with traditional exercise programs offered in the community centers in geriatric patients after hospital discharge from acute care.

The study is a randomized, controlled study conducted at Aarhus University Hospital (AUH). The population is elderly patients ≥65 years, residents in the Municipality of Aarhus and admitted acutely from there own home to the ED.

Telerehabilitation Group (TG) will start telerehabilitation first to second week after discharge. After the initial two training sessions, the patient will be included in a TG. When there is a group of two to three participants the group will stop including more members in that group in order to achieve the expected benefits of group exercising. It will be possible for physiotherapists to follow the team on the screen and to communicate with the participants. In addition, the participants may communicate with each other. The following four weeks the patients will exercise on their own in their training groups on appointed times via videoconferencing equipment.

The Control Group will receive the usual training offered by the municipality. Participants in both groups will be tested with the same instruments at baseline and after four and eight weeks and at six months.

Perspective If the presented project indicates that the older target group may benefit from telerehabilitation immediately after discharge, elderly patients may increase their Quality of Life and the municipalities may experience public savings.

Telerehabilitation may be a good alternative for patients who aren't able to receive training at the community center for physical reasons. Telerehabilitation may be one of the means to meet the challenge of the increasing proportion of elderly people in Denmark.


Condition or disease Intervention/treatment Phase
Frail Elderly Syndrome Other: Telerehabilitation Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Participants in the two groups will be asked not to inform the test investigator to which intervention they have been allocated. Baseline test will be performed before randomization in the hospital ward or in the participants home. Before re-test the participants in the intervention groups will ensure that the computer used for exercise is not visible in the room where the re-test is done.
Primary Purpose: Supportive Care
Official Title: Early Telerehabilitation After Hospital Discharge From Acute Care in Geriatric Patients. A Randomized Study With Four, Eight Weeks and Six Months Follow-up
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Telerehabilitation Group
Physiotherapist-supervised Telerehabilitation as home exercise in Groups. Participants in the intervention group receive supervised Telerehabilitation by an experienced physiotherapist two days a week during four weeks. A computer and a camera will be installed where the exercise should take place. It will make it possible for the physiotherapist to see how the participants follow the exercise program and for the participants to follow the physiotherapist instructions on the screen. The participants will be instructed in the use of computer and receive a written guide. After four weeks the participants will on their own continue the Otago exercise Program for another 4 weeks by video sessions and still together in their already established groups. Otago Exercise Program consist of a walking plan, balance exercises, and a set of leg muscle strengthening exercises all progressing in degree of difficulty.
Other: Telerehabilitation Group
The telerehabilitation Group receives physiotherapy supervised exercises on-line. The Community Center Group receives the traditionel training offer in the municipality Center for older people.
Other Name: Community Center Group

Active Comparator: Community Center group

The Community Center Group will receive the traditional exercise programs offered in a Community Center for older people. The exercise program can vary dependent on the offer in the individual community center. Often the training consists of exercises carried out in a range of different training equipments such as exercise bikes, steppers, rowing machines etc. often supervised by a physiotherapist. At some community centers the training will be performed in groups on appointed times. Some citizens are offered one or two times instruction and hereafter they have to train on their own. Some times the citizens are offered few times of training in their own home and hereafter follow the offer at the community center for older people. Before discharge, at the hospital, their plan for rehabilitation will be completed.

Participants in the Community Center Group will be tested by the same instruments at baseline and after 4 and 8 weeks and at 6 months of follow-up.

Other: Telerehabilitation Group
The telerehabilitation Group receives physiotherapy supervised exercises on-line. The Community Center Group receives the traditionel training offer in the municipality Center for older people.
Other Name: Community Center Group




Primary Outcome Measures :
  1. Change in Instrumental Activities of Daily Living (IADL) [ Time Frame: Measured at baseline and after 4 and 8 weeks and after 6 months ]
    IADL is measured by Functional Recovery Score (FRS). FRS is a questionnaire divided into three subjects such as Basic Activities of Daily Living (BADL), Instrumental Activities of Daily Living (IADL) and mobility (range 0-100 point).


Secondary Outcome Measures :
  1. Degree of loneliness [ Time Frame: Measured at baseline and after 4 and 8 weeks and after 6 months ]
    is measured by the University of California Los Angeles Loneliness Scale (UCLA). UCLA is a questionnaire consisting of 20 sub-questions describing subjective feelings of loneliness.

  2. Health-related quality of life and functional ability [ Time Frame: Measured at baseline and after 4 and 8 weeks and after 6 months ]
    measured by European Quality of Life-5 Domain (EQ-5D). It is a generic health-related quality of life instrument that has been used to describe population health and health outcomes in clinical trials. EQ-5D measures quality of life and functional capacity.

  3. Fear of falling [ Time Frame: Measured at baseline and after 4 and 8 weeks and after 6 months ]
    Fear of falling is measured by the Falls Efficacy Scale International (FES-I). FES-I is a questionnaire using a face-to-face interview. It consists of 14 questions.

  4. Mobility [ Time Frame: Mobiliy measured by Active Pal is measured after 4 weeks and 6 month ]
    Mobility is measured by Active Pal. Active Pal is a sensor placed on the thigh. It is able to measure a person's mobility up to seven days. It measures the number of steps and the time the person's femur is placed in both horizontal or vertical position and the number of minutes the person transfers from sitting to a standing position

  5. Balance and mobility [ Time Frame: A functional test, which consists of 15 items and measures mobility among frail elderly who are lying in bed or sitting in a comfort chair and the elderly, who are independent in everyday life. ]
    The De Morton Mobility Index



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • dependent on a walking aid at discharge
  • familiar with the use of computer
  • informed consent

Exclusion Criteria:

  • terminal illness
  • inability to walk independent with a walking aid
  • inability to speak or understand Danish
  • dementia i.e. Short Portable Mental Status Questionnaire (SPMSQ) score above 4
  • acute stroke
  • inability to complete the Otago Exercise Program without having a great risk of falling

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952858


Locations
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Denmark
Department of Geriatrics, AUH
Aarhus N, Denmark, 8200
Department of Geriatric, Aarhus University Hospital, Palle Juul-Jensens Bld. 99
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Bodil K.B. Jørgensen, MHS AUH, Department of Geriatric, Palle Juul-Jensens Bld 8200 Aarhus N, DK
Study Chair: Else marie S. Damsgaard, Professor AUH, Department of Geriatric, Palle Juul-Jensens Bld. 99, 8200 Aarhus N, Dk
Study Director: Merete Gregersen, PhD AUH, Department of Geriatric, Palle Juul-Jensens Bld. 99, 8200 Aarhus N, Dk

Additional Information:
Publications:
Kjøller M, Davidsen M, Juel K, Sundhedsstyrelsen. Ældrebefolkningens sundhedstilstand i Danmark. Kbh.: Sundhedsstyrelsen
World Health Organization. Defining Adherence: section 1 - Setting the scene: chapter one - Defining Adherence. In: World Health Organization, editor. Adherence to Long Term Therapies - Evidence for action
Pedersen LH, Gregersen M, Barat I, Damsgaard EM. Early geriatric follow-up after discharge reduces mortality among patients living in their own home

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03952858     History of Changes
Other Study ID Numbers: Telerehab
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Aarhus:
telerehabilitation