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Completed

NCT Number: NCT00974506

Pilot Study: Complementary Therapies in Geriatric Patients

In a randomized controlled pilot study the investigators include geriatric patients living in a geriatric residential community. Two interventions are compared:

1. a complex intervention containing exercise therapy, nutritional advice, homeopathy and naturopathy in addition to routine therapy by the general practitioner 2. routine care by general practitioner

The investigators assess the effect of the complex intervention on activities of daily living (AMPS, Barthel Index, Nosger), quality of life (Qualidem, Profile of Wellbeing), risk of falls (Tinetti), falls, cognition (Minimental Status Test), hospital admissions, medication use.

The results of this exploratory study are needed to plan a randomized controlled trial (RCT) with confirmatory design in the future.

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Key information

Conditions

Geriatric Patients

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center

Berlin, State of Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • living in shared flat/residential community
  • informed consent of patient or authorized representative

Exclusion criteria

  • participation in another study within the last 6 months
  • acute or chronic disease condition that does not allow participation
  • actual use of complementary therapies

Treatment and study plan

CAM-intervention

Other

Complex intervention containing exercise therapy, nutritional advice, homeopathic treatment, naturopathic treatment in addition to routine care therapy by general practitioner

Routine care therapy

Other

Routine care therapy by general practitioner

Secondary outcomes

  1. Assessment of motor and process skills (AMPS)

    Time frame: 3, 6, 12 months

  2. Qualidem

    Time frame: 3, 6, 12 months

  3. Barthel Index

    Time frame: 3, 6, 12 months

  4. Nurses Observation Scale for Geriatric Patients

    Time frame: 3, 6, 12 months

  5. Minimental Status Test

    Time frame: 12 months

  6. Tinetti Test

    Time frame: 3, 6, 12 months

  7. Profile of Wellbeing

    Time frame: 3, 6, 12 months

  8. Medication use and Potentially Inappropriate Medication Use (Beers Criteria 2003)

    Time frame: 3, 6, 12 months

  9. Falls (Esslinger Sturzprotokoll)

    Time frame: 12 months

  10. hospital admissions

    Time frame: 12 months

  11. Adverse effects

    Time frame: 12 months

  12. Interviews with health care team and relatives.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Homöopathie Stiftung
  • omoeon e.V.

Registry information

Official study title

Pilot Study Complementary Therapies in Geriatric Patients

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 10, 2009
Registry last updated
Jul 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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