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

December 12, 2024 updated by: Eling de Bruin, Eastern Switzerland University of Applied Sciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
    • Saint Gallen
      • St. Gallen, Saint Gallen, Switzerland, 9001
        • Recruiting
        • Eastern Switzerland University of Applied Sciences
        • Sub-Investigator:
          • Anne Kelso
        • Sub-Investigator:
          • Steffen Heinrich
        • Sub-Investigator:
          • Anita Schwarz
        • Sub-Investigator:
          • Caroline Tanner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video-based exericse program
Video-based exercise program "Bliib fit - mach mit!"
Other: Video-based exercise program
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.
Active Comparator: Caregiver-led activation program
An activation (exercise) program that is instructed and carried out by care professionals as optimized standard care.
Other: Caregiver-led activation program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends
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.
Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends
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.
Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends
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.
Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends
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.
Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends
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.
Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Switzerland University of Applied Sciences

Investigators

  • Principal Investigator: Eling de Bruin, Prof., Eastern Switzerland University of Applied Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 27, 2024

First Submitted That Met QC Criteria

December 12, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024-01990

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Exercise Program

Clinical Trials on Video-based exercise program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe