Best Function of Range of Motion (cRCT)

NCT ID: NCT04207307

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-03
• Study Completion Date: 2025-08-12

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).

Conditions

Mobility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Multimodal exercise intervention

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).

Group Type: EXPERIMENTAL

Multimodal exercise program

Intervention Type: BEHAVIORAL

Multimodal exercise intervention (machine-based resistance, coordination and endurance training).

Usual Care

General recommendations for healthy ageing, usual physical activity. No machine-based strength training intervention.

Group Type: SHAM_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

General recommendations for healthy ageing, no machine-based strength training intervention.

Interventions

Multimodal exercise program

Multimodal exercise intervention (machine-based resistance, coordination and endurance training).

Intervention Type: BEHAVIORAL

Usual Care

General recommendations for healthy ageing, no machine-based strength training intervention.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prof. Otto Beisheim Foundation

OTHER

Sponsor Role: collaborator

Institute for Medical Informatics, Statistics and Epidemiology (IMedIS)

UNKNOWN

Sponsor Role: collaborator

Münchner Studienzentrum (MSZ)

UNKNOWN

Sponsor Role: collaborator

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Halle, MD

Role: STUDY_DIRECTOR

Department of Prevention, Rehabilitation and Sports Medicine

Locations

Department of Prevention, Rehabilitation and Sports Medicine, Faculty of Medicine, Technichal University of Munich

Munich, Bavaria, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 37605110 (View on PubMed)

Other Identifiers

bestform_122019

Identifier Type: -

Identifier Source: org_study_id