NCT04207307

Best Function of Range of Motion (cRCT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 404 (actual)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Mobility

Interventions

Type	Name	Description
BEHAVIORAL	Multimodal exercise program	Multimodal exercise intervention (machine-based resistance, coordination and endurance training).
BEHAVIORAL	Usual Care	General recommendations for healthy ageing, no machine-based strength training intervention.

Timeline

• Start date: 2020-11-03
• Primary completion: 2023-08-04
• Completion: 2025-08-12
• First posted: 2019-12-20
• Last updated: 2025-12-11

Locations

1 site across 1 country: Germany