MobilitybestformNCT04207307
Best Function of Range of Motion (cRCT)
A study testing Multimodal exercise program in people with Mobility, run by Technical University of Munich at 1 site in Germany.
Trial summary
Mobility is a crucial factor for independence and quality of life in older people. However, the majority of those in retirement homes are not physically active to maintain mobility and independence. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mobility
- What is being tested?
- Multimodal exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 404 participants
- Where
- 1 siteGermany
- Study dates
- 3 Nov 2020to 12 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Study participant must be resident of one of the participating retirement homes
- Written informed consent of the study participant or legal representative
- Being able to stand independently (without assistance)
Who cannot join
- Any acute or chronic illness or physical/mental condition as well as any form of dementia, which does not allow to stand independently or which does not allow physical training in small groups or which would require a training with medical supervision
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Prevention, Rehabilitation and Sports Medicine, Faculty of Medicine, Technichal University of Munich
Munich, Bavaria, 80992
About this study
Mobility is a crucial factor for independence and quality of life in older people. However, the majority of those in retirement homes are not physically active to maintain mobility and independence.
The aim of the cluster randomized controlled bestform trial in 20 retirement homes (1:1 randomization) is to evaluate the efficacy of a multimodal exercise program for older people living in retirement homes in comparison to usual care over 6 months.
Read more
Within the intervention facilities, the participants will take part in a physical activity program over 6 months (2 times a week à 45 min) consisting of machine-based strength, coordination and endurance training.
Criteria of effectiveness are changes in physical function (primary endpoint: Change of Short Physical Performance Battery Score after 6 months) and the following secondary endpoints: mobility and balance, rate of falls, cardiometabolic risk factors, myocard function, quality of life and lifestyle factors (nutrition, physical activity), assessed by medical assessments, physical performance tests and various questionnaires after 3 and 6 months. Follow-up data will be collected after 18 and 30 months (questionnaire).
Read the detailed description
Mobility is a crucial factor for independence and quality of life at old age. Particularly those in retirement homes have a reduced physical activity status.
The aim of the bestform trial is the integration of an exercise concept comprising resistance, coordination and endurance training in retirement homes to promote mobility and independence as well as to reduce the risk of falling in older people.
The study is organized and conducted as a multi-center, two-armed cluster randomized study in 20 retirement homes (1:1 randomization in intervention retirement homes and control retirement homes with usual care) in the area of Munich, Germany. A total of at least 400 older people will subsequently be recruited. It is expected to recruit n≥20 older people per participating retirement home.
The intervention group will participate in an exercise training for 6 months, which will take place in the period from March 2020 to October 2021 (extended until August 2023). The multimodal intervention consists of a machine-based resistance, coordination and endurance training, which is performed 1-2 times per week for 30-45 minutes with increasing amount of training. Age and disability adapted pneumatic resistance training machines are used targeting large muscle groups. The endurance training is performed on upright-bicycle and recumbent bicycle ergometers. Coordination is exercised statically on the floor or a balance pad and dynamically on a balance-platform according to the individual training plan.
The aim of the bestform trial is to examine the efficacy of this multimodal training on physical function measured by the Short Physical Performance Battery (SPPB) (primary endpoint) over a 6-month period.
In addition, the impact of the training on mobility and balance, physical capacity (6-min-walk test), rate of falls, anthropometric parameters, cardiometabolic risk parameters (echocardiography, blood parameters), fear of falling, quality of life and other life style factors (nutrition, physical activity) assessed by medical assessments, physical performance tests and various questionnaires will be investigated after 3 and 6 months. Follow-up data will be collected after 18 and 30 months (questionnaire).
- Conditions
- Mobility
- Being tested
- Multimodal exercise program, Usual Care
- Keywords
- older people, oldest old, frailty, sarcopenia, exercise, resistance training, elderly, falls
- Medical subject headings
- Frailty, Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal exercise programBehavioural
Multimodal exercise intervention (machine-based resistance, coordination and endurance training).
Usual CareBehavioural
General recommendations for healthy ageing, no machine-based strength training intervention.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal exercise intervention | Experimental | Behavioral: Multimodal exercise intervention with machine-based resistance, coordination and endurance training, 1-2 times per week for 30-45 min (increasing amount of training). Receives: Behavioral: Multimodal exercise program |
| Usual Care | Sham comparator | General recommendations for healthy ageing, usual physical activity. No machine-based strength training intervention. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Short Physical Performance Battery
The Short Physical Performance Battery is a summary performance score out of 3 tests (standing balance test, gait speed test, and chair-stand-test). Categories of performance will be formed for each performance test (0 points to 4 points) and a summary score will be used. The sum score ranges from 0 (worst performance) to 12 (best performance).
Measured: Baseline to 6 months
Secondary outcomes (18)
Change in balance ability and mobility
Change in balance ability and mobility is measured by the Timed-Up-and-Go-Test. A higher time needed (measured in seconds) in the test is associated with more deficits in mobility.
Measured: Change after 3 and 6 months
Change in physical capacity
Change in physical capacity is measured by the 6-min-walk test. A lower distance (measured in meters) in the 6-min-walk test is associated with lower exercise capacity and general health status.
Measured: Change after 3 and 6 months
Change in handgrip strength
Change in handgrip strength is measured by a hand dynamometer.
Measured: Change after 3 and 6 months
Rate of falls
Rate of falls is measured by a fall diary.
Measured: 6 months
Change in body composition
Change in body composition is measured by bioelectrical impedance analysis.
Measured: Change after 3 and 6 months
Change in body weight
Change in body weight is measured with a scale. Weight and weight change in kilograms can be used to identify participants, who are at risk of obesity or malnutrition.
Measured: Change after 3 and 6 months
Change in calf circumference
Change in calf circumference is measured by tape.
Measured: Change after 3 and 6 months
Change in cardiac function
Change in cardiac function is measured by echocardiography.
Measured: Change after 6 months
Change in inflammatory marker
Change in biomarkers associated with inflammation and immunological function.
Measured: Change after 3 and 6 months
Change in brain-derived neutrophic factor
Change in brain-derived neutrophic factor is measured by the concentration of brain-derived neutrophic factor in serum.
Measured: Change after 3 and 6 months
Change in fear of falling
Change in fear of falling is measured by the short Falls Efficacy Scale questionnaire. The questionnaire comprises 7 items with 4 answer options (0 to 4 points). To obtain the total score, the sum of points of all answers was calculated. A higher score indicates a higher level of fear of falling.
Measured: Change after 3 and 6 months
Change in quality of life
Change in quality of life is measured by WHO-5 (Well-Being Index) questionnaire. The questionnaire comprises 5 statements about the feeling over the past 2 weeks (0 to 5 points). The raw score is multiplied by 4. The final score range from 0 (worst imaginable well-being) to 100 (best imaginable well-being).
Measured: Change after 3 and 6 months
Change in nutritional status
Change in nutritional status is measured by Mini Nutritional Assessment (MNA®-SF). The questionnaire comprises 6 questions. The sum of points of all answers is calculated. 12-14 points indicate a normal nutritional status, 8-11 points a risk of malnutrition, and 0-7 points is classified as malnourished.
Measured: Change after 3 and 6 months
Change in activity of daily living
Change in activity of daily living is measured by the Barthel-Index. The Barthel-Index comprises 10 items (0-15 points). The sum of points of all answers is calculated. Lower scores indicate a higher grade of disability.
Measured: Change after 3 and 6 months
Change in risk for sarcopenia
Change in risk for sarcopenia is measured by SARC-F-questionnaire. The questionnaire comprises five components. The sum of points of all answers is calculated. The sum score ranges from 0 (best) to 10 (worst).
Measured: Change after 3 and 6 months
Change in cognition
Changes in cognition is measured by the Montreal Cognitive Assessment (MoCA). The MoCA test is scored out of 30 points.
Measured: Change after 6 months
Change in Short Physical Performance Battery
The Short Physical Performance Battery is a summary performance score out of 3 tests (standing balance test, gait speed test, and chair-stand-test). Categories of performance will be formed for each performance test (0 points to 4 points) and a summary score will be used. The sum score ranges from 0 (worst performance) to 12 (best performance).
Measured: Baseline to 3 months
Follow-up evaluation of MACE
Major adverse cardiac events (MACE) and all-cause mortality will be documented during the follow-up. MACE are cardiovascular death, non-fatal stroke, and non-fatal myocardial infarction (3-point MACE).
Measured: Changes over 18 and 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start3 Nov 2020
- Primary completion4 Aug 2023
- Study completion12 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MobilityStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial (1:1)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Otto Beisheim Foundation, Institute for Medical Informatics, Statistics and Epidemiology (IMedIS), Münchner Studienzentrum (MSZ)
- Responsible party
- Sponsor
- Investigators
- Martin Halle, MD, Study director, Department of Prevention, Rehabilitation and Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207307
- Sponsor's protocol ID
- bestform_122019
- Acronym
- bestform
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2019
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siegrist M, Schaller N, Weiss M, Isaak J, Schmid V, Koppel E, Weichenberger M, Mende E, Haller B, Halle M. Study protocol of a cluster-randomised controlled trial assessing a multimodal machine-based exercise training programme in senior care facilities over 6 months - the bestform study (best function of range of motion). BMC Geriatr. 2023 Aug 22;23(1):505. doi: 10.1186/s12877-023-04176-7.
PubMed 37605110
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best Function of Range of Motion (cRCT)
- ClinicalTrials.gov ID
- NCT04207307
- Acronym / sponsor ID
- bestform / bestform_122019
- Conditions
- Mobility
- Keywords
- older people, oldest old, frailty, sarcopenia, exercise, resistance training, elderly, falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Prof. Otto Beisheim Foundation, Institute for Medical Informatics, Statistics and Epidemiology (IMedIS), Münchner Studienzentrum (MSZ)
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 4 Aug 2023 (actual)
- Study completion
- 12 Aug 2025 (actual)
- First posted
- 20 Dec 2019 (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.
Mobility is a crucial factor for independence and quality of life in older people. However, the majority of those in retirement homes are not physically active to maintain mobility and independence.
The aim of the cluster randomized controlled bestform trial in 20 retirement homes (1:1 randomization) is to evaluate the efficacy of a multimodal exercise program for older people living in retirement homes in comparison to usual care over 6 months.
Within the intervention facilities, the participants will take part in a physical activity program over 6 months (2 times a week à 45 min) consisting of machine-based strength, coordination and endurance training.
Criteria of effectiveness are changes in physical function (primary endpoint: Change of Short Physical Performance Battery Score after 6 months) and the following secondary endpoints: mobility and balance, rate of falls, cardiometabolic risk factors, myocard function, quality of life and lifestyle factors (nutrition, physical activity), assessed by medical assessments, physical performance tests and various questionnaires after 3 and 6 months. Follow-up data will be collected after 18 and 30 months (questionnaire).
Detailed description
Mobility is a crucial factor for independence and quality of life at old age. Particularly those in retirement homes have a reduced physical activity status.
The aim of the bestform trial is the integration of an exercise concept comprising resistance, coordination and endurance training in retirement homes to promote mobility and independence as well as to reduce the risk of falling in older people.
The study is organized and conducted as a multi-center, two-armed cluster randomized study in 20 retirement homes (1:1 randomization in intervention retirement homes and control retirement homes with usual care) in the area of Munich, Germany. A total of at least 400 older people will subsequently be recruited. It is expected to recruit n≥20 older people per participating retirement home.
The intervention group will participate in an exercise training for 6 months, which will take place in the period from March 2020 to October 2021 (extended until August 2023). The multimodal intervention consists of a machine-based resistance, coordination and endurance training, which is performed 1-2 times per week for 30-45 minutes with increasing amount of training. Age and disability adapted pneumatic resistance training machines are used targeting large muscle groups. The endurance training is performed on upright-bicycle and recumbent bicycle ergometers. Coordination is exercised statically on the floor or a balance pad and dynamically on a balance-platform according to the individual training plan.
The aim of the bestform trial is to examine the efficacy of this multimodal training on physical function measured by the Short Physical Performance Battery (SPPB) (primary endpoint) over a 6-month period.
In addition, the impact of the training on mobility and balance, physical capacity (6-min-walk test), rate of falls, anthropometric parameters, cardiometabolic risk parameters (echocardiography, blood parameters), fear of falling, quality of life and other life style factors (nutrition, physical activity) assessed by medical assessments, physical performance tests and various questionnaires will be investigated after 3 and 6 months. Follow-up data will be collected after 18 and 30 months (questionnaire).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial (1:1)
| Arm | Type | Receives |
|---|---|---|
| Multimodal exercise intervention | Experimental | Behavioral: Multimodal exercise programBehavioral: Multimodal exercise intervention with machine-based resistance, coordination and endurance training, 1-2 times per week for 30-45 min (increasing amount of training). |
| Usual Care | Sham comparator | Behavioral: Usual CareGeneral recommendations for healthy ageing, usual physical activity. No machine-based strength training intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Study participant must be resident of one of the participating retirement homes
- Written informed consent of the study participant or legal representative
- Being able to stand independently (without assistance)
Key exclusion criteria (1 listed)
- Any acute or chronic illness or physical/mental condition as well as any form of dementia, which does not allow to stand independently or which does not allow physical training in small groups or which would require a training with medical supervision
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 |
|---|---|---|
| Multimodal exercise programMultimodal exercise intervention (machine-based resistance, coordination and endurance training). | Behavioural | Multimodal exercise intervention |
| Usual CareGeneral recommendations for healthy ageing, no machine-based strength training intervention. | Behavioural | Usual Care |
Primary outcome
Change in Short Physical Performance Battery
Time frame: Baseline to 6 months
The Short Physical Performance Battery is a summary performance score out of 3 tests (standing balance test, gait speed test, and chair-stand-test). Categories of performance will be formed for each performance test (0 points to 4 points) and a summary score will be used. The sum score ranges from 0 (worst performance) to 12 (best performance).
18 secondary outcomes
Change in balance ability and mobility
Time frame: Change after 3 and 6 months
Change in physical capacity
Time frame: Change after 3 and 6 months
Change in handgrip strength
Time frame: Change after 3 and 6 months
Rate of falls
Time frame: 6 months
Change in body composition
Time frame: Change after 3 and 6 months
Change in body weight
Time frame: Change after 3 and 6 months
Change in calf circumference
Time frame: Change after 3 and 6 months
Change in cardiac function
Time frame: Change after 6 months
Change in inflammatory marker
Time frame: Change after 3 and 6 months
Change in brain-derived neutrophic factor
Time frame: Change after 3 and 6 months
Change in fear of falling
Time frame: Change after 3 and 6 months
Change in quality of life
Time frame: Change after 3 and 6 months
Change in nutritional status
Time frame: Change after 3 and 6 months
Change in activity of daily living
Time frame: Change after 3 and 6 months
Change in risk for sarcopenia
Time frame: Change after 3 and 6 months
Change in cognition
Time frame: Change after 6 months
Change in Short Physical Performance Battery
Time frame: Baseline to 3 months
Follow-up evaluation of MACE
Time frame: Changes over 18 and 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Derived from this study: PubMed 37605110Siegrist M, Schaller N, Weiss M, Isaak J, Schmid V, Koppel E, Weichenberger M, Mende E, Haller B, Halle M. Study protocol of a cluster-randomised controlled trial assessing a multimodal machine-based exercise training programme in senior care facilities over 6 months - the bestform study (best function of range of motion). BMC Geriatr. 2023 Aug 22;23(1):505. doi: 10.1186/s12877-023-04176-7.
- 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. This study is not recruiting at the moment.
Martin Halle, MD study director
Department of Prevention, Rehabilitation and Sports Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal exercise program in people with Mobility, run by Technical University of Munich at 1 site in Germany.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 11 Dec 2025. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Short Physical Performance Battery (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04207307, which also lists 1 linked publication.
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 11 Dec 2025.