Clinical trial NCT04207307: Best Function of Range of Motion (cRCT)
Official title: Best Function of Range of Motion (cRCT)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mobility
Keywords: older people
oldest old
frailty
sarcopenia
exercise
resistance training
elderly
falls
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Prof. Otto Beisheim Stiftung
name: Institute for Medical Informatics, Statistics and Epidemiology (IMedIS)
name: Münchner Studienzentrum (MSZ)
First posted: 2019-12-20
Enrollment: 404
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial (1:1)
Primary purpose: TREATMENT

Brief 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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Short Physical Performance Battery
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in balance ability and mobility
timeFrame: Change after 3 and 6 months
measure: Change in physical capacity
timeFrame: Change after 3 and 6 months
measure: Change in handgrip strength
timeFrame: Change after 3 and 6 months
measure: Rate of falls
timeFrame: 6 months
measure: Change in body composition
timeFrame: Change after 3 and 6 months
measure: Change in body weight
timeFrame: Change after 3 and 6 months
measure: Change in calf circumference
timeFrame: Change after 3 and 6 months
measure: Change in cardiac function
timeFrame: Change after 6 months
measure: Change in inflammatory marker
timeFrame: Change after 3 and 6 months
measure: Change in brain-derived neutrophic factor
timeFrame: Change after 3 and 6 months
measure: Change in fear of falling
timeFrame: Change after 3 and 6 months
measure: Change in quality of life
timeFrame: Change after 3 and 6 months
measure: Change in nutritional status
timeFrame: Change after 3 and 6 months
measure: Change in activity of daily living
timeFrame: Change after 3 and 6 months
measure: Change in risk for sarcopenia
timeFrame: Change after 3 and 6 months
measure: Change in cognition
timeFrame: Change after 6 months
measure: Change in Short Physical Performance Battery
timeFrame: Baseline to 3 months
measure: Follow-up evaluation of MACE
timeFrame: Changes over 18 and 30 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Prevention, Rehabilitation and Sports Medicine, Faculty of Medicine, Technichal University of Munich
state: Bavaria
Study officials:
affiliation: Department of Prevention, Rehabilitation and Sports Medicine
name: Martin Halle, MD
role: STUDY_DIRECTOR
References: