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NCT Number: NCT06738186

"Bliib Fit - Mach Mit!" in Residential Care Facilities

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eastern Switzerland University of Applied Sciences

Sankt Gallen, Canton of St. Gallen, 9001, Switzerland

Location status: Recruiting

Location contact

Anita Schwarz

SUB_INVESTIGATOR

Anne Kelso

SUB_INVESTIGATOR

Caroline Tanner

SUB_INVESTIGATOR

Steffen Heinrich

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Video-based exercise program

Other

The 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

The 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.

Primary outcomes

  1. Short Physical Performance Battery (SPPB)

    Time frame: Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends

    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.

  2. Grip strength

    Time frame: Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends

    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.

  3. 2-Minutes Walking Test

    Time frame: Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends

    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.

Secondary outcomes

  1. Health-related quality of life

    Time frame: Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends

    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.

  2. Falls Efficacy Scale

    Time frame: Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends

    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.

  3. Self-Efficacy

    Time frame: Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends

    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.

  4. Accelerometery

    Time frame: Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Kelso, Dr.

CONTACT

[email protected]

+41 58 257 15 93

Eling de Bruin, Prof.

CONTACT

[email protected]

+41 58 257 14 11

Sponsors and collaborators

Lead sponsor

Eastern Switzerland University of Applied Sciences

Other

Registry information

Official study title

"Bliib Fit - Mach Mit!" in Alters- Und Pflegeinstitutionen

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2024
Registry last updated
Dec 17, 2024

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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