Best Function of Range of Motion (cRCT)

NCT04207307 | Completed

• 1 other identifier: bestform_122019
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 1

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).

Conditions

Mobility

Keywords

older people; oldest old; frailty; sarcopenia; exercise; resistance training; elderly; falls

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Change in balance ability and mobility

  Change after 3 and 6 months

• Change in physical capacity

  Change after 3 and 6 months

• Change in handgrip strength

  Change after 3 and 6 months

• Rate of falls

  6 months

• Change in body composition

  Change after 3 and 6 months

Study Arms (2)

Multimodal exercise intervention

EXPERIMENTAL

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

Usual Care

SHAM COMPARATOR

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

Behavioral: Usual Care

Interventions

Multimodal exercise program BEHAVIORAL

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

Multimodal exercise intervention

Usual Care BEHAVIORAL

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

Usual Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead
• Prof. Otto Beisheim Foundation: collaborator
• Institute for Medical Informatics, Statistics and Epidemiology (IMedIS): collaborator
• Münchner Studienzentrum (MSZ): collaborator

Study Sites (1)

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

Munich, Bavaria, 80992, Germany

Location

Related Publications (1)

• 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.

  PMID: 37605110 DERIVED

MeSH Terms

Conditions

Frailty; Sarcopenia; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Behavior

Study Officials

• Martin Halle, MD

  Department of Prevention, Rehabilitation and Sports Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Primary endpoint is assessed by a rater who is otherwise not involved in the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized controlled trial (1:1)

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 20, 2019
• Study Start: November 3, 2020
• Primary Completion: August 4, 2023
• Study Completion: August 12, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)