Community-based Complex Intervention to Prevent Loss of Physical Function and Disability in Home-dwelling Older Adults

NCT04531852 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 360

Last updated 2021-08-18

No results posted yet for this study

Summary

The aim of this study is to compare the effect of 12 weeks group-based exercise program enhanced with 24 weeks health empowerment program (HEP) to an extended usual care condition (the HEP program alone) on physical function, disability, health-related quality of life (HQoL) in home-dwelling older adults at risk for disability. Interventions were implemented into existing health care pathways and added to routine preventive programs using a two-armed randomized intervention design with multiple sites.

Conditions

  • Disability Physical

Interventions

OTHER

CALSTI - Complex Active Lifestyle Intervention

A group-based exercise (EX) and health empowerment program (HEP) conducted in the local area. Structured, progressive resistance (55-60%), balance (10-15%), endurance (10-15%) exercise was delivered twice weekly for 12 weeks under supervision of a trained instructor. HEP consists of 8 group sessions aiming to facilitate long-term behaviour change, by empowering older citizens to act on current risk behaviours (i.e. low physical activity/exercise, high sedentary behaviour, social isolation, poor dietary habits, incontinence). Four sessions were conducted during the exercise intervention period (phase 1 - intensive), and four sessions in the following 12 weeks (phase 2 - maintenance).

BEHAVIORAL

SEMAI - Self-Management Intervention

A low-cost enhancement of the existing preventive service where citizens are information about relevant health resources. Citizens allocated to SEMAI intervention are offered the health-empowerment program as outlined above, including four extra sessions dedicated to practical experiences with exercising. 24 weeks duration in total, with eight sessions in phase 1 and four sessions in phase 2

Sponsors & Collaborators

  • Esbjerg Municipality

    collaborator OTHER_GOV
  • Municipality of Slagelse

    collaborator UNKNOWN
  • Municipality of Odense

    collaborator OTHER_GOV
  • Christian Albrechts Universität zu Kiel

    collaborator UNKNOWN
  • Europa Universität Flensburg

    collaborator UNKNOWN
  • AOK Nordwest

    collaborator INDUSTRY
  • Howe Fiedler Stiftung Kiel

    collaborator UNKNOWN
  • Arla Foods - Denmark

    collaborator UNKNOWN
  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Paolo Caserotti, PhD · University of Southern Denmark

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-22
Primary Completion
2019-11-29
Completion
2019-12-22

Countries

  • Denmark

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 NCT04531852 on ClinicalTrials.gov