NCT06738186

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

December 5, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

1.1 years

First QC Date

November 27, 2024

Last Update Submit

December 12, 2024

Conditions

Keywords

physical activity promotionexercisephysical fitnesselderlyresidential care facility

Outcome Measures

Primary Outcomes (3)

  • 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.

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

  • 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.

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

  • 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.

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

Secondary Outcomes (4)

  • Health-related quality of life

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

  • Falls Efficacy Scale

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

  • Self-Efficacy

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

  • Accelerometery

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

Study Arms (2)

Video-based exericse program

EXPERIMENTAL

Video-based exercise program "Bliib fit - mach mit!"

Other: Video-based exercise program

Caregiver-led activation program

ACTIVE COMPARATOR

An activation (exercise) program that is instructed and carried out by care professionals as optimized standard care.

Other: Caregiver-led activation program

Interventions

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.

Video-based exericse 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.

Caregiver-led activation program

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Switzerland University of Applied Sciences

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

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Eling de Bruin, Prof.

    Eastern Switzerland University of Applied Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eling de Bruin, Prof.

CONTACT

Anne Kelso, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

November 27, 2024

First Posted

December 17, 2024

Study Start

December 5, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

December 17, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations