Telerehabilitation in Geriatric Patients at Aarhus University Hospital, Denmark

NCT03952858 | Withdrawn DMC

• 1 other identifier: Telerehab
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Frail Elderly Syndrome

Keywords

telerehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Instrumental Activities of Daily Living (IADL)

  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).

  Measured at baseline and after 4 and 8 weeks and after 6 months

Secondary Outcomes (5)

• Degree of loneliness

  Measured at baseline and after 4 and 8 weeks and after 6 months

• Health-related quality of life and functional ability

  Measured at baseline and after 4 and 8 weeks and after 6 months

• Fear of falling

  Measured at baseline and after 4 and 8 weeks and after 6 months

• Mobility

  Mobiliy measured by Active Pal is measured after 4 weeks and 6 month

• Balance and mobility

  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.

Study Arms (2)

Telerehabilitation Group

EXPERIMENTAL

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

Community Center group

ACTIVE COMPARATOR

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

Interventions

Telerehabilitation Group OTHER

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.

Also known as: Community Center Group

Community Center group; Telerehabilitation Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (2)

Department of Geriatric, Aarhus University Hospital, Palle Juul-Jensens Bld. 99

Aarhus, 8200, Denmark

Location

Department of Geriatrics, AUH

Aarhus N, 8200, Denmark

Location

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Related Links

• Sundhedsstyrelsen, Statens Institut for Folkesundhed. Danskernes sundhed.dk. 2017
• Otago Exercise Programme, to prevent falls in older adults
• University V. REDCap
• IT - anvendelse i befolkningen - Danmarks statistik. 2017

Study Officials

• Bodil K.B. Jørgensen, MHS

  AUH, Department of Geriatric, Palle Juul-Jensens Bld 8200 Aarhus N, DK

  PRINCIPAL INVESTIGATOR

• Else marie S. Damsgaard, Professor

  AUH, Department of Geriatric, Palle Juul-Jensens Bld. 99, 8200 Aarhus N, Dk

  STUDY CHAIR

• Merete Gregersen, PhD

  AUH, Department of Geriatric, Palle Juul-Jensens Bld. 99, 8200 Aarhus N, Dk

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 16, 2019
• Study Start: March 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: May 5, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)