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Pilates as an Adjuvant Therapy in Parkinson Disease.

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pilates
Conventional Exercise
Sponsored by
University of Vigo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease focused on measuring Parkinson Disease, Neurodegenerative Disorder, Physical Activity, Pilates Method, Stabilometer

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stages 1 through 3 on the Hoehn and Yahr Staging Scale;
  • Stable reaction to anti-Parkinson medication;
  • Not having taken part in any physical exercise program during the month prior to the study.

Exclusion Criteria:

  • People with PD who were not able to ambulate independently or presented any comorbidities other than PD or any acute illness that would make training inappropriate.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Pilates

    Conventional Exercise

    Arm Description

    The Pilates program covered a 12-week period, two weekly sessions. In one session, exercises were performed on a mat (Mat Pilates), and in the second session in standing and sitting position. The programme included warm-up exercises, the main part of the session and cooling activities.

    The conventional exercise programme covered a 12-week period, two weekly sessions. The programme aimed at improving aerobic capacity, muscular resistance, balance and flexibility. The program combined land-based and water-based exercise sessions.

    Outcomes

    Primary Outcome Measures

    Motor impairment.
    The Spanish adapted version of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) was administered to assess the impact of the intervention on the motor impairment and disability related to PD. The MDS-UPDRS total score ranges from zero to 200, with higher scores indicating a greater impact of PD symptoms.

    Secondary Outcome Measures

    Anthropometric Measurements.
    The height (cm) and weight (kg) of the participants were measured without shoes and in light clothing. The body mass index (BMI) was calculated using the following formula: weight / height2 (kg/m2).
    Change from baseline Anthropometric Measurements at week 15.
    The height (cm) and weight (kg) of the participants were measured without shoes and in light clothing. The body mass index (BMI) was calculated using the following formula: weight / height2 (kg/m2).
    Change from week 15 Anthropometric Measurements at week 18 follow-up.
    The height (cm) and weight (kg) of the participants were measured without shoes and in light clothing. The body mass index (BMI) was calculated using the following formula: weight / height2 (kg/m2).
    Static Balance at baseline.
    The static balance was evaluated using the TecnoBody Prokin 3 platform. The assessment protocol was developed in a sitting and standing position, with open (OE) and closed (CE) eyes. The participants had three 30-second attempts to perform the position with open and closed eyes and a 60-second interval of active rest between them. The static balance parameters assessed were the centre of pressure of the body in the frontal plane, the centre of pressure of the body in the sagittal plane, the amplitude movement of the centre of pressure in the sagittal plane, the amplitude movement of the centre of pressure in the frontal plane, the average speed of oscillation movement of the centre of pressure in the sagittal plane, the average speed of oscillation movement of the centre of pressure in the frontal plane, the sum of distances of the amount of movement of the centre of pressure, and the displacement area of the centre of pressure.
    Change from baseline Static Balance at 15 weeks.
    The static balance was evaluated using the TecnoBody Prokin 3 platform. The assessment protocol was developed in a sitting and standing position, with open (OE) and closed (CE) eyes. The participants had three 30-second attempts to perform the position with open and closed eyes and a 60-second interval of active rest between them. The static balance parameters assessed were the centre of pressure of the body in the frontal plane, the centre of pressure of the body in the sagittal plane, the amplitude movement of the centre of pressure in the sagittal plane, the amplitude movement of the centre of pressure in the frontal plane, the average speed of oscillation movement of the centre of pressure in the sagittal plane, the average speed of oscillation movement of the centre of pressure in the frontal plane, the sum of distances of the amount of movement of the centre of pressure, and the displacement area of the centre of pressure.
    Change from week 15 Static Balance at week 18 follow-up.
    The static balance was evaluated using the TecnoBody Prokin 3 platform. The assessment protocol was developed in a sitting and standing position, with open (OE) and closed (CE) eyes. The participants had three 30-second attempts to perform the position with open and closed eyes and a 60-second interval of active rest between them. The static balance parameters assessed were the centre of pressure of the body in the frontal plane, the centre of pressure of the body in the sagittal plane, the amplitude movement of the centre of pressure in the sagittal plane, the amplitude movement of the centre of pressure in the frontal plane, the average speed of oscillation movement of the centre of pressure in the sagittal plane, the average speed of oscillation movement of the centre of pressure in the frontal plane, the sum of distances of the amount of movement of the centre of pressure, and the displacement area of the centre of pressure.
    Change from baseline Motor Impairment at 15 weeks.
    The Spanish adapted version of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) was administered to assess the impact of the intervention on the motor impairment and disability related to PD. The MDS-UPDRS total score ranges from zero to 200, with higher scores indicating a greater impact of PD symptoms.
    Change from week 15 Motor Impairment at week 18 follow-up.
    The Spanish adapted version of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) was administered to assess the impact of the intervention on the motor impairment and disability related to PD. The MDS-UPDRS total score ranges from zero to 200, with higher scores indicating a greater impact of PD symptoms.

    Full Information

    First Posted
    September 18, 2017
    Last Updated
    September 20, 2017
    Sponsor
    University of Vigo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03294031
    Brief Title
    Pilates as an Adjuvant Therapy in Parkinson Disease.
    Official Title
    Pilates as an Adjuvant Physical Exercise Therapy in Patients With Parkinson Disease.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 11, 2016 (Actual)
    Primary Completion Date
    May 27, 2016 (Actual)
    Study Completion Date
    May 27, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Vigo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Although Pilates has been proposed as a useful rehabilitation strategy in PD, research on its feasibility and potential effects on the motor symptoms and balance with this population is scarce. Some works have included Pilates as part of combined exercise session interventions, but information concerning their specific effects was not provided. Under these circumstances, this study aims at identifying the effects of adding Pilates as part of a conventional exercise rehabilitation program on the motor symptoms and static balance of PD persons. Participants (n=15) were assigned to a Pilates (PG) or to a conventional exercise group (CG) and performed one land-based and one water-based exercise session per week for 14 weeks. The MDS-UPDRS and a stabilometer were used to assess the impact of the intervention on the participant´s motor symptoms and static balance.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    Parkinson Disease, Neurodegenerative Disorder, Physical Activity, Pilates Method, Stabilometer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pilates
    Arm Type
    Experimental
    Arm Description
    The Pilates program covered a 12-week period, two weekly sessions. In one session, exercises were performed on a mat (Mat Pilates), and in the second session in standing and sitting position. The programme included warm-up exercises, the main part of the session and cooling activities.
    Arm Title
    Conventional Exercise
    Arm Type
    Active Comparator
    Arm Description
    The conventional exercise programme covered a 12-week period, two weekly sessions. The programme aimed at improving aerobic capacity, muscular resistance, balance and flexibility. The program combined land-based and water-based exercise sessions.
    Intervention Type
    Other
    Intervention Name(s)
    Pilates
    Intervention Description
    Warm-up exercises included Abdominal and costal breathing and Pelvic Clock. Some exercises included in the main part of the mat session were Arm arcs, Curls up, Femur arcs, Shoulder bridge, Leg circles, among others. The main part of the sitting/standing session included in standing position exercises like Standing on one leg with support, Neck rolls, Side leg lift with support and in sitting position Spine stretch 5", Elbows back with hands behind his head, Heel/knee slides, Shoulder drops, Knee folds, among others. In mat sessions, cooling exercises included in standing position Hamstring stretch and Abdominal Breathing and Rest position and in sitting/standing session Stretching and Abdominal Breathing.
    Intervention Type
    Other
    Intervention Name(s)
    Conventional Exercise
    Intervention Description
    All sessions started with a 15-minute warm-up phase based on walking performance and joint mobility exercises. It was followed by a 35-minute second phase, which included low-impact aerobics (music tempo was set at 120 beats per minute), gross motor coordination tasks and balance activities. The final 5-minute phase focused on gentle stretching exercises.
    Primary Outcome Measure Information:
    Title
    Motor impairment.
    Description
    The Spanish adapted version of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) was administered to assess the impact of the intervention on the motor impairment and disability related to PD. The MDS-UPDRS total score ranges from zero to 200, with higher scores indicating a greater impact of PD symptoms.
    Time Frame
    The participants were assessed one week before starting the program (week #0).
    Secondary Outcome Measure Information:
    Title
    Anthropometric Measurements.
    Description
    The height (cm) and weight (kg) of the participants were measured without shoes and in light clothing. The body mass index (BMI) was calculated using the following formula: weight / height2 (kg/m2).
    Time Frame
    The participants were assessed one week before starting the program (week #0).
    Title
    Change from baseline Anthropometric Measurements at week 15.
    Description
    The height (cm) and weight (kg) of the participants were measured without shoes and in light clothing. The body mass index (BMI) was calculated using the following formula: weight / height2 (kg/m2).
    Time Frame
    The participants were assessed one week after the programme was completed (week #15).
    Title
    Change from week 15 Anthropometric Measurements at week 18 follow-up.
    Description
    The height (cm) and weight (kg) of the participants were measured without shoes and in light clothing. The body mass index (BMI) was calculated using the following formula: weight / height2 (kg/m2).
    Time Frame
    Follow-up assessment was performed four weeks after training ended (week #18).
    Title
    Static Balance at baseline.
    Description
    The static balance was evaluated using the TecnoBody Prokin 3 platform. The assessment protocol was developed in a sitting and standing position, with open (OE) and closed (CE) eyes. The participants had three 30-second attempts to perform the position with open and closed eyes and a 60-second interval of active rest between them. The static balance parameters assessed were the centre of pressure of the body in the frontal plane, the centre of pressure of the body in the sagittal plane, the amplitude movement of the centre of pressure in the sagittal plane, the amplitude movement of the centre of pressure in the frontal plane, the average speed of oscillation movement of the centre of pressure in the sagittal plane, the average speed of oscillation movement of the centre of pressure in the frontal plane, the sum of distances of the amount of movement of the centre of pressure, and the displacement area of the centre of pressure.
    Time Frame
    The participants were assessed one week before starting the program (week #0).
    Title
    Change from baseline Static Balance at 15 weeks.
    Description
    The static balance was evaluated using the TecnoBody Prokin 3 platform. The assessment protocol was developed in a sitting and standing position, with open (OE) and closed (CE) eyes. The participants had three 30-second attempts to perform the position with open and closed eyes and a 60-second interval of active rest between them. The static balance parameters assessed were the centre of pressure of the body in the frontal plane, the centre of pressure of the body in the sagittal plane, the amplitude movement of the centre of pressure in the sagittal plane, the amplitude movement of the centre of pressure in the frontal plane, the average speed of oscillation movement of the centre of pressure in the sagittal plane, the average speed of oscillation movement of the centre of pressure in the frontal plane, the sum of distances of the amount of movement of the centre of pressure, and the displacement area of the centre of pressure.
    Time Frame
    The participants were assessed one week after the programme was completed (week #15).
    Title
    Change from week 15 Static Balance at week 18 follow-up.
    Description
    The static balance was evaluated using the TecnoBody Prokin 3 platform. The assessment protocol was developed in a sitting and standing position, with open (OE) and closed (CE) eyes. The participants had three 30-second attempts to perform the position with open and closed eyes and a 60-second interval of active rest between them. The static balance parameters assessed were the centre of pressure of the body in the frontal plane, the centre of pressure of the body in the sagittal plane, the amplitude movement of the centre of pressure in the sagittal plane, the amplitude movement of the centre of pressure in the frontal plane, the average speed of oscillation movement of the centre of pressure in the sagittal plane, the average speed of oscillation movement of the centre of pressure in the frontal plane, the sum of distances of the amount of movement of the centre of pressure, and the displacement area of the centre of pressure.
    Time Frame
    Follow-up assessment was performed four weeks after training ended (week #18).
    Title
    Change from baseline Motor Impairment at 15 weeks.
    Description
    The Spanish adapted version of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) was administered to assess the impact of the intervention on the motor impairment and disability related to PD. The MDS-UPDRS total score ranges from zero to 200, with higher scores indicating a greater impact of PD symptoms.
    Time Frame
    The participants were assessed one week after the programme was completed (week #15).
    Title
    Change from week 15 Motor Impairment at week 18 follow-up.
    Description
    The Spanish adapted version of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) was administered to assess the impact of the intervention on the motor impairment and disability related to PD. The MDS-UPDRS total score ranges from zero to 200, with higher scores indicating a greater impact of PD symptoms.
    Time Frame
    Follow-up assessment was performed four weeks after training ended (week #18).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Stages 1 through 3 on the Hoehn and Yahr Staging Scale; Stable reaction to anti-Parkinson medication; Not having taken part in any physical exercise program during the month prior to the study. Exclusion Criteria: People with PD who were not able to ambulate independently or presented any comorbidities other than PD or any acute illness that would make training inappropriate.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    José María Cancela-Carral, Ph.D.
    Organizational Affiliation
    University of Vigo
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Pilates as an Adjuvant Therapy in Parkinson Disease.

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