"Bliib Fit - Mach Mit!" in Residential Care Facilities
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorEastern Switzerland University of Applied Sciences
About this trial
The goal of this clinical trial is to learn, if the video-based exercise program "Bliib fit - mach mit!" can be used to improve physical fitness in older adults living in residential care facilities. The main questions it aims to answer are:
Does the video-based exercise program improve participants' physical fitness? Does the video-based exercise program improve participants' quality of life, perceived fall risk, self-efficacy and daily physical activity levels?
Researchers will compare this exercise program to an optimized standard care activation program (caregiver-led) to see if the video-based program can affect physical fitness in older adults living in residential care facilities.
Participants will participate in the exercise or activation program for 12 weeks, four times a week, with each session lasting 20 minutes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Written informed consent
Low to moderate risk of falling
Physically and cognitively able to independently carry out exercise instructions (based on referral of clinical staff on site)
Mini Mental State Examination (MMSE) test score ≥ 20
Disqualifiers
Inability to speak or understand German
High risk of falling
Unstable cardiovascular condition or other health condition, which does not support a safe participation in exercise program (based on referral of clinical staff on site, patient file)
Scheduled transfer to another institution within the next 3 months
Trial design
Design model
Parallel
Treatments tested in this trial
Video-based exercise program
Other interventionThe video-based exercise program - "Bliib fit -mach mit!" focuses on mobilization, muscle strengthening (focus on lower and upper extremities), coordination, balance, and relaxation. Each participant requires the use of a chair for support and to perform exercises in a seated position, if required. The group sessions are supervised by a care professional or registered activation specialist of the residential care facility.
Caregiver-led activation program
Other interventionThe caregiver-led activation program (DESKK- Demenzspezifisches Kurzzeitpflegekonzept) is instructed and carried out by care professionals (e.g., nursing staff) as optimized standard care conducted individually or in groups.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Video-based exericse programExperimental treatment 1 intervention
Group B: Caregiver-led activation programActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Short Physical Performance Battery (SPPB)
Lower extremity function and mobility is assessed using the Short Physical Performance Battery (SPPB) (standing balance, gait speed, lower extremity strength). The SPPB is an objective and valid measurement instrument to assess lower extremity function and mobility (\> 65 years of age). The measurement instrument consists of three physical tasks: walking, chair-rise-test (sit-to-stand) and standing balance.
Time frame
Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends2
Grip strength
Upper extremity strength is assessed using the grip strength test (hand dynamometer). It is a relevant and valid assessment in older adults to assess muscle strength and overall physical function. Participants squeeze a hand dynamometer as hard as they can, three times with each hand.
Time frame
Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends3
2-Minutes Walking Test
Aerobic endurance is assessed via the 2-Minutes Walking test. The 2MWT is a submaximal exercise test to assess overall physical fitness and endurance in research and clinical practice. The distance covered in two minutes is recorded. Reference values for adults are available to determine presence of impairments in walking ability, functional endurance, and overall functional status. Oxygen saturation (SpO2) and heart rate (HR) are measured before and after the test using a pulse oximeter. Furthermore, dyspnea and the effort in both legs are measured before and after the test using the Borg scale.
Time frame
Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention endsSecondary outcomes
1
Health-related quality of life
The EuroQol 5-Dimension 5-level (EQ-5D-5L) is a validated 20-item questionnaire to determine health-related quality of life and comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
Time frame
Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends2
Falls Efficacy Scale
The FES-I Scale is a 16-item questionnaire to measure the concern of falling among older people and addresses various demanding activities inside and outside the home as well as social activities. The levels of concern about falling when carrying out different activities is rated on a four-point scale ranging from 1 = not all concerned to 4= very concerned.
Time frame
Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends3
Self-Efficacy
The Exercise Self-Efficacy Scale (ESES) evaluates individuals' confidence in their ability to participate in physical activity and serves as a valuable tool for measuring self-efficacy in this domain. The scale includes six variables and uses a 10-point response scale ranging from "not at all confident" to "very confident," with an option for no response.
Time frame
Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends4
Accelerometery
GENEactiv motion sensors (accelerometers) are used to examine daily physical activity levels over seven days. The lightweight device delivers continuous recording of high-resolution acceleration, which enables to classify a person's daily activities in terms of spent lying, sitting, standing, walking (steps), and sleeping. The device places minimal strain on the wearer, is waterproof, and will be worn as a wristband.
Time frame
Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention endsSponsors and contacts
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Source ClinicalTrials.gov