Physical Fitness in Older AdultsNCT06738186
"Bliib Fit - Mach Mit!" in Residential Care Facilities
A study testing Video-based exercise program and Caregiver-led activation program in people with Physical Fitness in Older Adults and Exercise Program, run by Eastern Switzerland University of Applied Sciences at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Physical Fitness in Older Adults, Exercise Program
- What is being tested?
- Video-based exercise program and Caregiver-led activation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Dec 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Eastern Switzerland University of Applied Sciences
Sankt Gallen, Canton of St. Gallen, 9001
Anne Kelso
Steffen Heinrich
About this study
Official title: "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?
Read more
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.
- Conditions
- Physical Fitness in Older Adults, Exercise Program
- Being tested
- Video-based exercise program, Caregiver-led activation program
- Keywords
- physical activity promotion, exercise, physical fitness, elderly, residential care facility
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-based exercise programOther
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 programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Video-based exericse program | Experimental | Video-based exercise program "Bliib fit - mach mit!" Receives: 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. Receives: Other: Caregiver-led activation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends
Secondary outcomes (4)
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.
Measured: Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends
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.
Measured: Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends
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.
Measured: Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends
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.
Measured: Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start5 Dec 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical Fitness in Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Switzerland University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eling de Bruin, Eastern Switzerland University of Applied Sciences
- Investigators
- Eling de Bruin, Prof., Principal investigator, Eastern Switzerland University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738186
- Sponsor's protocol ID
- 2024-01990
- Status last verified
- Dec 2024
- First submitted
- 27 Nov 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Bliib Fit - Mach Mit!" in Alters- Und Pflegeinstitutionen
- ClinicalTrials.gov ID
- NCT06738186
- Acronym / sponsor ID
- 2024-01990
- Conditions
- Physical Fitness in Older Adults, Exercise Program
- Keywords
- physical activity promotion, exercise, physical fitness, elderly, residential care facility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eastern Switzerland University of Applied SciencesUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-based exericse program | Experimental | Other: Video-based exercise programVideo-based exercise program "Bliib fit - mach mit!" |
| Caregiver-led activation program | Active comparator | Other: Caregiver-led activation programAn activation (exercise) program that is instructed and carried out by care professionals as optimized standard care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-based exercise programThe 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. | Other | Video-based exericse program |
| Caregiver-led activation programThe 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. | Other | Caregiver-led activation program |
Primary outcome
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.
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.
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.
4 secondary outcomes
Health-related quality of life
Time frame: 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
Self-Efficacy
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eling de Bruin, Prof. principal investigator
Eastern Switzerland University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-based exercise program and Caregiver-led activation program in people with Physical Fitness in Older Adults and Exercise Program, run by Eastern Switzerland University of Applied Sciences at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eling de Bruin, Prof. (+41 58 257 14 11, eling.debruin@ost.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (SPPB) (time frame: Baseline, end of intervention at 12 weeks, long-term follow-up 12 weeks after intervention ends). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.