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Best Function of Range of Motion (cRCT)

NCT04207307 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 404

Last updated 2025-12-11

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Prof. Otto Beisheim Foundation

    collaborator OTHER

  • Institute for Medical Informatics, Statistics and Epidemiology (IMedIS)

    collaborator UNKNOWN

  • Münchner Studienzentrum (MSZ)

    collaborator UNKNOWN

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Martin Halle, MD · Department of Prevention, Rehabilitation and Sports Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-03
Primary Completion
2023-08-04
Completion
2025-08-12

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04207307 on ClinicalTrials.gov