Pilates as an Adjuvant Therapy in Parkinson Disease.

September 20, 2017 updated by: Gustavo Rodríguez Fuentes, University of Vigo

Pilates as an Adjuvant Physical Exercise Therapy in Patients With Parkinson Disease.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

56 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pilates
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.
Other: Pilates
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.
Active Comparator: Conventional Exercise
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.
Other: Conventional Exercise
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Motor impairment.
Time Frame: The participants were assessed one week before starting the program (week #0).
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.
The participants were assessed one week before starting the program (week #0).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anthropometric Measurements.
Time Frame: The participants were assessed one week before starting the program (week #0).
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).
The participants were assessed one week before starting the program (week #0).
Change from baseline Anthropometric Measurements at week 15.
Time Frame: The participants were assessed one week after the programme was completed (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).
The participants were assessed one week after the programme was completed (week #15).
Change from week 15 Anthropometric Measurements at week 18 follow-up.
Time Frame: Follow-up assessment was performed four weeks after training ended (week #18).
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).
Follow-up assessment was performed four weeks after training ended (week #18).
Static Balance at baseline.
Time Frame: The participants were assessed one week before starting the program (week #0).
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.
The participants were assessed one week before starting the program (week #0).
Change from baseline Static Balance at 15 weeks.
Time Frame: The participants were assessed one week after the programme was completed (week #15).
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.
The participants were assessed one week after the programme was completed (week #15).
Change from week 15 Static Balance at week 18 follow-up.
Time Frame: Follow-up assessment was performed four weeks after training ended (week #18).
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.
Follow-up assessment was performed four weeks after training ended (week #18).
Change from baseline Motor Impairment at 15 weeks.
Time Frame: The participants were assessed one week after the programme was completed (week #15).
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.
The participants were assessed one week after the programme was completed (week #15).
Change from week 15 Motor Impairment at week 18 follow-up.
Time Frame: Follow-up assessment was performed four weeks after training ended (week #18).
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.
Follow-up assessment was performed four weeks after training ended (week #18).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Vigo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: José María Cancela-Carral, Ph.D., University of Vigo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 27, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 27, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015/484

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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