Best Function of Range of Motion (cRCT) (bestform)

  • STATUS
    Recruiting
  • End date
    Dec 3, 2024
  • participants needed
    400
  • sponsor
    Technische Universität München
Updated on 3 June 2022
Accepts healthy volunteers

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.

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).

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. 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).

Details
Condition Mobility
Treatment Usual Care, multimodal exercise program
Clinical Study IdentifierNCT04207307
SponsorTechnische Universität München
Last Modified on3 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note