Is Osteoporosis Education Effective in Parkinsonian Patients

Sponsor
Dokuz Eylul University (Other)
Overall Status
Completed
CT.gov ID
NCT04536610
Collaborator
(none)
54
1
2
10.3
5.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Providing structured osteoporosis education
  • Behavioral: Giving informative leaflet
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Effect Of Osteoporosis Education On Osteoporosis Knowledge Level and Daily Life In Parkinsonian Patients, Randomized Controlled Trial
Actual Study Start Date :
May 20, 2019
Actual Primary Completion Date :
Mar 30, 2020
Actual Study Completion Date :
Mar 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group

Providing structured OP education in addition to the informative leaflet. (The leaflet contained the same information as the OP education program)

Behavioral: Providing structured osteoporosis education
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.

Behavioral: Giving informative leaflet
Leaflets containe the same information as the OP education program

Active Comparator: Control group

Giving only the informative leaflet. (The leaflet contained the same information as the OP education program)

Behavioral: Giving informative leaflet
Leaflets containe the same information as the OP education program

Outcome Measures

Primary Outcome Measures

  1. Physical Activity Scale For The Elderly score at the endpoint [At 12th week]

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

  2. National Osteoporosis Foundation daily calcium intake scale score at the endpoint [At 12th week]

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

Secondary Outcome Measures

  1. Revised 2011 Osteoporosis Knowledge Test score at the endpoint [At 12th week]

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

  2. Smoking and alcohol use status at the endpoint [At 12th week]

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

  3. Amount of smoking and alcohol use at the endpoint [At 12th week]

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

  4. Frequency of falls at the endpoint [At 12th week]

    Times / last 1 month

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Male and female patients aged 50 years or older

  2. Being diagnosed with Parkinson's Disease

Exclusion Criteria:
  1. Severe physical and cognitive dysability

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dokuz Eylul University İzmir Turkey

Sponsors and Collaborators

  • Dokuz Eylul University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Selmin Gulbahar, Clinical Professor of Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Dokuz Eylul University
ClinicalTrials.gov Identifier:
NCT04536610
Other Study ID Numbers:
  • Kerim OP Parkinson
First Posted:
Sep 2, 2020
Last Update Posted:
Sep 2, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Selmin Gulbahar, Clinical Professor of Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Dokuz Eylul University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 2, 2020