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NCT Number: NCT04536610

Is Osteoporosis Education Effective in Parkinsonian Patients

The effects of osteoporosis (OP) education on OP patients and the normal population studied and described in numerous studies. But the effects of OP education on Parkinsonian patients have not been sufficiently elucidated.

The purpose of this study was to evaluate the effect of OP education on the OP knowledge level and daily life in Parkinsonian patients.

Our hypothesis is; to Parkinsonian patients; there is a statistically significant difference in terms of OP knowledge level and daily life between giving only informative leaflets about OP and also providing structured OP education.

54 participants aged 50 and older with Parkinson's Disease were randomized to the experimental and control groups. While only leaflets were given to the control group, structured OP education was also given to the experimental group. Patients were evaluated with the same structured face-to-face interviews at the entrance and 12 weeks later.

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Key information

Conditions

Osteoporosis Basal Ganglia Diseases Bone Diseases Bone Diseases, Metabolic Brain Diseases Central Nervous System Diseases Metabolic Diseases Movement Disorders Musculoskeletal Diseases Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University

Izmir, Turkey (Türkiye)

About this study

The OP education was performed in groups of 4-5 people by a single physician in the form of verbal expression via slide, with a duration of 20 minutes and in the form of a single session. Our leaflets contained the same information as the OP education program.

Face-to-face interviews include; Revised 2011 Osteoporosis Knowledge Test (rOKT) (0-32 points) for OP knowledge levels; National Osteoporosis Foundation daily calcium intake scale [NOF, (mg)], Physical Activity Scale For The Elderly (PASE, 0-763 points), smoking and alcohol use status (Yes/No) and quantities (cigarette pack/per week, alcohol unit/per week), frequency of falls (times/last 1 month) were questioned for effects on daily life.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female patients aged 50 years or older
  • Being diagnosed with Parkinson's Disease

Exclusion criteria

  • Severe physical and cognitive dysability

Treatment and study plan

Providing structured osteoporosis education

Behavioral

The OP education was performed in groups of 4-5 people by a single physician with a single session in the form of verbal expression via slide, with a duration of 20 minutes.

Giving informative leaflet

Behavioral

Leaflets containe the same information as the OP education program

Primary outcomes

  1. Physical Activity Scale For The Elderly score at the endpoint

    Time frame: At 12th week

    (0-763 points) Higher scores mean a better outcome

  2. National Osteoporosis Foundation daily calcium intake scale score at the endpoint

    Time frame: At 12th week

    (250mg - ... mg) Higher scores mean a better outcome

Secondary outcomes

  1. Revised 2011 Osteoporosis Knowledge Test score at the endpoint

    Time frame: At 12th week

    (0-32 points) Higher scores mean a better outcome

  2. Smoking and alcohol use status at the endpoint

    Time frame: At 12th week

    (Yes/No) "No" is a better status

  3. Amount of smoking and alcohol use at the endpoint

    Time frame: At 12th week

    (Cigarette pack / per week, alcohol unit / per week). Lower scores mean a better outcome

  4. Frequency of falls at the endpoint

    Time frame: At 12th week

    Times / last 1 month

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

The Effect Of Osteoporosis Education On Osteoporosis Knowledge Level and Daily Life In Parkinsonian Patients, Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 2, 2020
Registry last updated
Sep 2, 2020

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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