NCT02716844

Brief Summary

Aim: Investigating the effects of Clinical Pilates Exercise on kinesiophobia, pain, functional status and quality of life of the patients diagnosed with osteoporosis. Method: 47 patients were assessed and randomly divided into 2 groups. Exercise group patients joined exercise program regularly that was held 3 times a week, 1 hour a day, during 6 weeks with physiotherapist. Control group patients continued their normal daily lives without any exercise. After 7 patients quit the study for various reasons, 40 women with primary osteoporosis (control group n=20, exercise group n= 20), completed the study and were assessed at the beginning and at the end of 6 weeks. As assesment' measurements Tampa Kinesiophobia Scale (TKS), Visual Analog Scale (VAS), Short Form McGill (SF-McGill), Pain Disability Index (PDI), Oswestry Disability Index (ODI), Berg Balance Test (BBT), Timed Up- Go Test (TUG), Chair Sit-Stand Test (CSST), Chair Sit and Reach Test (CSRT), Back Scratch Test (BST), Quality of life Questionnaire European Foundation for Osteoporosis (QUALEFFO-41), Hospital Anxiety and Depression Scale (HADS), Satisfaction with Life Scale (SLS) and Health Assesment Questionnaire (HAQ) were performed.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
Last Updated

March 24, 2016

Status Verified

March 1, 2016

Enrollment Period

1.2 years

First QC Date

March 3, 2016

Last Update Submit

March 23, 2016

Conditions

Osteoporosis

Keywords

OsteoporosisClinic Pilates ExerciseKinesiophobiaPain

Outcome Measures

Primary Outcomes (1)

  • Change in the level of fear and avoidance associated with movement assessed using the Tampa Kinesiophobia Scale at 6 weeks

    40 osteoporosis patients filled Tampa Kinesiophobia Scale at the beginning and at the end of 6 weeks in order to measure the level of fear and avoidance associated with movement. If an individual receives a high score, according to the scale, this result indicates a high level of kinesiophobia . It has not a specific unit. There is not an adverse events in this test.

    At the beginning and at the end of 6 weeks

Secondary Outcomes (15)

  • Change in the level of pain intensity in the morning assessed using Visual Analogue Scale (VAS) at 6 weeks.

    At the beginning and at the end of 6 weeks

  • Change in the level of pain intensity during activity assessed using Visual Analogue Scale (VAS) at 6 weeks.

    At the beginning and at the end of 6 weeks

  • Change in the level of pain intensity at rest assessed using Visual Analogue Scale (VAS) at 6 weeks.

    At the beginning and at the end of 6 weeks

  • Change in the level of experienced pain assessed with using Short Form - McGill Pain Questionnaire (SF-McGill)

    At the beginning and at the end of 6 weeks

  • Change in the level of influence of patients' general pain intensity on their daily life activities and functionality assessed using Pain Disability Index (PDI).

    At the beginning and at the end of 6 weeks

  • +10 more secondary outcomes

Study Arms (2)

Exercise Group,

EXPERIMENTAL

Clinical Pilates exercise were given for 6 weeks, 3 days in a week

Other: Exercise

Control Group

NO INTERVENTION

Nothing given to control group, told to continue their normal life for 6 weeks.

Interventions

ExerciseOTHER

Clinical Pilates exercise were given for 6 weeks, 3 days in a week

Exercise Group,

Eligibility Criteria

Age50 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Woman diagnosed with osteoporosis between the ages 50-75 within the last year

You may not qualify if:

  • History of fractures
  • Joint replacements or fixation of the joints at the lower extremities or the spine
  • Any neurological or muscle diseases
  • Inability to continuously attend the exercise program
  • Any secondary diseases resulting in decreased mobility or functional status
  • Visual, hearing or mental problems that could prevent communication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OsteoporosisKinesiophobiaPain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPhobic DisordersAnxiety DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Instructor

Study Record Dates

First Submitted

March 3, 2016

First Posted

March 23, 2016

Study Start

January 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 24, 2016

Record last verified: 2016-03