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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Mobility
• Intervention / Treatment: Behavioral: Multimodal exercise program; Behavioral: Usual Care

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 Type: Interventional
• Enrollment (Actual): 404
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Monika Siegrist, PhD; Phone Number: 41 0049 89 289 244; Email: Monika.Siegrist@mri.tum.de
• Study Contact Backup: Name: Nina Schaller; Phone Number: 41 0049 89 289 244; Email: Nina.Schaller@mri.tum.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80992
      • Department of Prevention, Rehabilitation and Sports Medicine, Faculty of Medicine, Technichal University of Munich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: Multimodal exercise program; Multimodal exercise intervention (machine-based resistance, coordination and endurance training).
Sham Comparator: Usual Care; General recommendations for healthy ageing, usual physical activity. No machine-based strength training intervention.	Behavioral: Usual Care; General recommendations for healthy ageing, no machine-based strength training intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Change after 3 and 6 months
Change in handgrip strength	Change in handgrip strength is measured by a hand dynamometer.	Change after 3 and 6 months
Rate of falls	Rate of falls is measured by a fall diary.	6 months
Change in body composition	Change in body composition is measured by bioelectrical impedance analysis.	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.	Change after 3 and 6 months
Change in calf circumference	Change in calf circumference is measured by tape.	Change after 3 and 6 months
Change in cardiac function	Change in cardiac function is measured by echocardiography.	Change after 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.	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.	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).	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.	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.	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).	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.	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).	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).	Changes over 18 and 30 months
Change in inflammatory marker	Change in biomarkers associated with inflammation and immunological function.	Change after 3 and 6 months

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: Prof. Otto Beisheim Stiftung; Institute for Medical Informatics, Statistics and Epidemiology (IMedIS); Münchner Studienzentrum (MSZ)
• Investigators: Study Director: Martin Halle, MD, Department of Prevention, Rehabilitation and Sports Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2020
• Primary Completion (Actual): August 4, 2023
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: December 16, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 20, 2019

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: exercise; frailty; elderly; falls; sarcopenia; resistance training; older people; oldest old
• Other Study ID Numbers: bestform_122019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No