<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03294031</url>
  </required_header>
  <id_info>
    <org_study_id>2015/484</org_study_id>
    <nct_id>NCT03294031</nct_id>
  </id_info>
  <brief_title>Pilates as an Adjuvant Therapy in Parkinson Disease.</brief_title>
  <official_title>Pilates as an Adjuvant Physical Exercise Therapy in Patients With Parkinson Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Vigo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Vigo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although Pilates has been proposed as a useful rehabilitation strategy in PD, research on its&#xD;
      feasibility and potential effects on the motor symptoms and balance with this population is&#xD;
      scarce. Some works have included Pilates as part of combined exercise session interventions,&#xD;
      but information concerning their specific effects was not provided. Under these&#xD;
      circumstances, this study aims at identifying the effects of adding Pilates as part of a&#xD;
      conventional exercise rehabilitation program on the motor symptoms and static balance of PD&#xD;
      persons. Participants (n=15) were assigned to a Pilates (PG) or to a conventional exercise&#xD;
      group (CG) and performed one land-based and one water-based exercise session per week for 14&#xD;
      weeks. The MDS-UPDRS and a stabilometer were used to assess the impact of the intervention on&#xD;
      the participant´s motor symptoms and static balance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 11, 2016</start_date>
  <completion_date type="Actual">May 27, 2016</completion_date>
  <primary_completion_date type="Actual">May 27, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Motor impairment.</measure>
    <time_frame>The participants were assessed one week before starting the program (week #0).</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anthropometric Measurements.</measure>
    <time_frame>The participants were assessed one week before starting the program (week #0).</time_frame>
    <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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Anthropometric Measurements at week 15.</measure>
    <time_frame>The participants were assessed one week after the programme was completed (week #15).</time_frame>
    <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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 15 Anthropometric Measurements at week 18 follow-up.</measure>
    <time_frame>Follow-up assessment was performed four weeks after training ended (week #18).</time_frame>
    <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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Static Balance at baseline.</measure>
    <time_frame>The participants were assessed one week before starting the program (week #0).</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Static Balance at 15 weeks.</measure>
    <time_frame>The participants were assessed one week after the programme was completed (week #15).</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 15 Static Balance at week 18 follow-up.</measure>
    <time_frame>Follow-up assessment was performed four weeks after training ended (week #18).</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline Motor Impairment at 15 weeks.</measure>
    <time_frame>The participants were assessed one week after the programme was completed (week #15).</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from week 15 Motor Impairment at week 18 follow-up.</measure>
    <time_frame>Follow-up assessment was performed four weeks after training ended (week #18).</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Pilates</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pilates</intervention_name>
    <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&quot;, 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.</description>
    <arm_group_label>Pilates</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional Exercise</intervention_name>
    <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.</description>
    <arm_group_label>Conventional Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stages 1 through 3 on the Hoehn and Yahr Staging Scale;&#xD;
&#xD;
          -  Stable reaction to anti-Parkinson medication;&#xD;
&#xD;
          -  Not having taken part in any physical exercise program during the month prior to the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  People with PD who were not able to ambulate independently or presented any&#xD;
             comorbidities other than PD or any acute illness that would make training&#xD;
             inappropriate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>José María Cancela-Carral, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>University of Vigo</affiliation>
  </overall_official>
  <reference>
    <citation>Abbruzzese G, Marchese R, Avanzino L, Pelosin E. Rehabilitation for Parkinson's disease: Current outlook and future challenges. Parkinsonism Relat Disord. 2016 Jan;22 Suppl 1:S60-4. doi: 10.1016/j.parkreldis.2015.09.005. Epub 2015 Sep 3.</citation>
    <PMID>26360239</PMID>
  </reference>
  <reference>
    <citation>Ayan C, Cancela JM, Gutierrez-Santiago A, Prieto I. Effects of two different exercise programs on gait parameters in individuals with Parkinson's disease: a pilot study. Gait Posture. 2014;39(1):648-51. doi: 10.1016/j.gaitpost.2013.08.019. Epub 2013 Sep 7.</citation>
    <PMID>24021522</PMID>
  </reference>
  <reference>
    <citation>Di Giulio I, St George RJ, Kalliolia E, Peters AL, Limousin P, Day BL. Maintaining balance against force perturbations: impaired mechanisms unresponsive to levodopa in Parkinson's disease. J Neurophysiol. 2016 Aug 1;116(2):493-502. doi: 10.1152/jn.00996.2015. Epub 2016 Apr 20.</citation>
    <PMID>27098030</PMID>
  </reference>
  <reference>
    <citation>Dibble LE, Addison O, Papa E. The effects of exercise on balance in persons with Parkinson's disease: a systematic review across the disability spectrum. J Neurol Phys Ther. 2009 Mar;33(1):14-26. doi: 10.1097/NPT.0b013e3181990fcc.</citation>
    <PMID>19265767</PMID>
  </reference>
  <reference>
    <citation>Johnson L, Putrino D, James I, Rodrigues J, Stell R, Thickbroom G, Mastaglia FL. The effects of a supervised Pilates training program on balance in Parkinson's disease. Advances in Parkinson Disease 2: 58-61, 2013.</citation>
  </reference>
  <reference>
    <citation>Kalron A, Rosenblum U, Frid L, Achiron A. Pilates exercise training vs. physical therapy for improving walking and balance in people with multiple sclerosis: a randomized controlled trial. Clin Rehabil. 2017 Mar;31(3):319-328. doi: 10.1177/0269215516637202. Epub 2016 Jul 10.</citation>
    <PMID>26951348</PMID>
  </reference>
  <reference>
    <citation>Kamioka H, Tsutani K, Katsumata Y, Yoshizaki T, Okuizumi H, Okada S, Park SJ, Kitayuguchi J, Abe T, Mutoh Y. Effectiveness of Pilates exercise: A quality evaluation and summary of systematic reviews based on randomized controlled trials. Complement Ther Med. 2016 Apr;25:1-19. doi: 10.1016/j.ctim.2015.12.018. Epub 2016 Jan 4.</citation>
    <PMID>27062942</PMID>
  </reference>
  <reference>
    <citation>King LA, Horak FB. Delaying mobility disability in people with Parkinson disease using a sensorimotor agility exercise program. Phys Ther. 2009 Apr;89(4):384-93. doi: 10.2522/ptj.20080214. Epub 2009 Feb 19.</citation>
    <PMID>19228832</PMID>
  </reference>
  <reference>
    <citation>Klamroth S, Steib S, Devan S, Pfeifer K. Effects of Exercise Therapy on Postural Instability in Parkinson Disease: A Meta-analysis. J Neurol Phys Ther. 2016 Jan;40(1):3-14. doi: 10.1097/NPT.0000000000000117.</citation>
    <PMID>26655098</PMID>
  </reference>
  <reference>
    <citation>Martinez-Martin P, Rodriguez-Blazquez C, Alvarez-Sanchez M, Arakaki T, Bergareche-Yarza A, Chade A, Garretto N, Gershanik O, Kurtis MM, Martinez-Castrillo JC, Mendoza-Rodriguez A, Moore HP, Rodriguez-Violante M, Singer C, Tilley BC, Huang J, Stebbins GT, Goetz CG. Expanded and independent validation of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). J Neurol. 2013 Jan;260(1):228-36. doi: 10.1007/s00415-012-6624-1. Epub 2012 Aug 5.</citation>
    <PMID>22865238</PMID>
  </reference>
  <reference>
    <citation>Santamato A, Ranieri M, Panza F, Zoccolella S, Frisardi V, Solfrizzi V, Amoruso MT, Amoruso L, Fiore P. Botulinum toxin type A and a rehabilitation program in the treatment of Pisa syndrome in Parkinson's disease. J Neurol. 2010 Jan;257(1):139-41. doi: 10.1007/s00415-009-5310-4. No abstract available.</citation>
    <PMID>19763384</PMID>
  </reference>
  <results_reference>
    <citation>Ayan C, Varela S, Vila MH, Seijo-Martinez M, Cancela JM. Treadmill training combined with water and land-based exercise programs: Effects on Parkinson's disease patients. NeuroRehabilitation. 2016 Jun 30;39(2):295-9. doi: 10.3233/NRE-161360.</citation>
    <PMID>27372364</PMID>
  </results_reference>
  <results_reference>
    <citation>Bergamin M, Gobbo S, Bullo V, Zanotto T, Vendramin B, Duregon F, Cugusi L, Camozzi V, Zaccaria M, Neunhaeuserer D, Ermolao A. Effects of a Pilates exercise program on muscle strength, postural control and body composition: results from a pilot study in a group of post-menopausal women. Age (Dordr). 2015 Dec;37(6):118. doi: 10.1007/s11357-015-9852-3. Epub 2015 Nov 15.</citation>
    <PMID>26578458</PMID>
  </results_reference>
  <results_reference>
    <citation>Bird ML, Hill KD, Fell JW. A randomized controlled study investigating static and dynamic balance in older adults after training with Pilates. Arch Phys Med Rehabil. 2012 Jan;93(1):43-9. doi: 10.1016/j.apmr.2011.08.005. Epub 2011 Oct 5.</citation>
    <PMID>21975148</PMID>
  </results_reference>
  <results_reference>
    <citation>Cattaneo D, Jonsdottir J, Regola A, Carabalona R. Stabilometric assessment of context dependent balance recovery in persons with multiple sclerosis: a randomized controlled study. J Neuroeng Rehabil. 2014 Jun 10;11:100. doi: 10.1186/1743-0003-11-100.</citation>
    <PMID>24912561</PMID>
  </results_reference>
  <results_reference>
    <citation>Bang DH, Cho HS. Effect of body awareness training on balance and walking ability in chronic stroke patients: a randomized controlled trial. J Phys Ther Sci. 2016 Jan;28(1):198-201. doi: 10.1589/jpts.2016.198. Epub 2016 Jan 30.</citation>
    <PMID>26957757</PMID>
  </results_reference>
  <results_reference>
    <citation>de Oliveira Francisco C, de Almeida Fagundes A, Gorges B. Effects of Pilates method in elderly people: Systematic review of randomized controlled trials. J Bodyw Mov Ther. 2015 Jul;19(3):500-8. doi: 10.1016/j.jbmt.2015.03.003. Epub 2015 Mar 20.</citation>
    <PMID>26118523</PMID>
  </results_reference>
  <results_reference>
    <citation>Donath L, Roth R, Hurlimann C, Zahner L, Faude O. Pilates vs. Balance Training in Health Community-Dwelling Seniors: a 3-arm, Randomized Controlled Trial. Int J Sports Med. 2016 Mar;37(3):202-10. doi: 10.1055/s-0035-1559695. Epub 2015 Dec 2.</citation>
    <PMID>26630547</PMID>
  </results_reference>
  <results_reference>
    <citation>Guclu-Gunduz A, Citaker S, Irkec C, Nazliel B, Batur-Caglayan HZ. The effects of pilates on balance, mobility and strength in patients with multiple sclerosis. NeuroRehabilitation. 2014;34(2):337-42. doi: 10.3233/NRE-130957.</citation>
    <PMID>23949064</PMID>
  </results_reference>
  <results_reference>
    <citation>King LA, Salarian A, Mancini M, Priest KC, Nutt J, Serdar A, Wilhelm J, Schlimgen J, Smith M, Horak FB. Exploring outcome measures for exercise intervention in people with Parkinson's disease. Parkinsons Dis. 2013;2013:572134. doi: 10.1155/2013/572134. Epub 2013 Apr 30.</citation>
    <PMID>23738230</PMID>
  </results_reference>
  <results_reference>
    <citation>Kucuk F, Kara B, Poyraz EC, Idiman E. Improvements in cognition, quality of life, and physical performance with clinical Pilates in multiple sclerosis: a randomized controlled trial. J Phys Ther Sci. 2016 Mar;28(3):761-8. doi: 10.1589/jpts.28.761. Epub 2016 Mar 31.</citation>
    <PMID>27134355</PMID>
  </results_reference>
  <results_reference>
    <citation>La Touche R, Escalante K, Linares MT. Treating non-specific chronic low back pain through the Pilates Method. J Bodyw Mov Ther. 2008 Oct;12(4):364-70. doi: 10.1016/j.jbmt.2007.11.004. Epub 2008 Feb 1.</citation>
    <PMID>19083695</PMID>
  </results_reference>
  <results_reference>
    <citation>Lange C, Unnithan VB, Larkam E, Latta PM. Maximizing the benefits of Pilates-inspired exercise for learning functional motor skills. Journal of Bodywork and Movement Therapies 4: 99-108, 2000.</citation>
  </results_reference>
  <results_reference>
    <citation>Markovic G, Sarabon N, Greblo Z, Krizanic V. Effects of feedback-based balance and core resistance training vs. Pilates training on balance and muscle function in older women: a randomized-controlled trial. Arch Gerontol Geriatr. 2015 Sep-Oct;61(2):117-23. doi: 10.1016/j.archger.2015.05.009. Epub 2015 May 27.</citation>
    <PMID>26036209</PMID>
  </results_reference>
  <results_reference>
    <citation>Phrompaet S, Paungmali A, Pirunsan U, Sitilertpisan P. Effects of pilates training on lumbo-pelvic stability and flexibility. Asian J Sports Med. 2011 Mar;2(1):16-22. doi: 10.5812/asjsm.34822.</citation>
    <PMID>22375213</PMID>
  </results_reference>
  <results_reference>
    <citation>Schmitz-Hubsch T, Pyfer D, Kielwein K, Fimmers R, Klockgether T, Wullner U. Qigong exercise for the symptoms of Parkinson's disease: a randomized, controlled pilot study. Mov Disord. 2006 Apr;21(4):543-8. doi: 10.1002/mds.20705.</citation>
    <PMID>16229022</PMID>
  </results_reference>
  <results_reference>
    <citation>Tolnai N, Szabo Z, Koteles F, Szabo A. Physical and psychological benefits of once-a-week Pilates exercises in young sedentary women: A 10-week longitudinal study. Physiol Behav. 2016 Sep 1;163:211-218. doi: 10.1016/j.physbeh.2016.05.025. Epub 2016 May 16.</citation>
    <PMID>27195456</PMID>
  </results_reference>
  <results_reference>
    <citation>Volpe D, Giantin MG, Maestri R, Frazzitta G. Comparing the effects of hydrotherapy and land-based therapy on balance in patients with Parkinson's disease: a randomized controlled pilot study. Clin Rehabil. 2014 Dec;28(12):1210-7. doi: 10.1177/0269215514536060. Epub 2014 Jun 3.</citation>
    <PMID>24895382</PMID>
  </results_reference>
  <results_reference>
    <citation>Wells C, Kolt GS, Marshall P, Bialocerkowski A. Indications, benefits, and risks of Pilates exercise for people with chronic low back pain: a Delphi survey of Pilates-trained physical therapists. Phys Ther. 2014 Jun;94(6):806-17. doi: 10.2522/ptj.20130568. Epub 2014 Apr 3.</citation>
    <PMID>24700138</PMID>
  </results_reference>
  <results_reference>
    <citation>Wong-Yu IS, Mak MK. Multi-dimensional balance training programme improves balance and gait performance in people with Parkinson's disease: A pragmatic randomized controlled trial with 12-month follow-up. Parkinsonism Relat Disord. 2015 Jun;21(6):615-21. doi: 10.1016/j.parkreldis.2015.03.022. Epub 2015 Mar 31.</citation>
    <PMID>25899544</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>September 20, 2017</last_update_submitted>
  <last_update_submitted_qc>September 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Vigo</investigator_affiliation>
    <investigator_full_name>Gustavo Rodríguez Fuentes</investigator_full_name>
    <investigator_title>Ph.D.</investigator_title>
  </responsible_party>
  <keyword>Parkinson Disease</keyword>
  <keyword>Neurodegenerative Disorder</keyword>
  <keyword>Physical Activity</keyword>
  <keyword>Pilates Method</keyword>
  <keyword>Stabilometer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03294031
org study id: 2015/484
nct id: NCT03294031
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Motor impairment.
time frame: The participants were assessed one week before starting the program (week #0).
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.
measure: Anthropometric Measurements.
time frame: The participants were assessed one week before starting the program (week #0).
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).
measure: Change from baseline Anthropometric Measurements at week 15.
time frame: The participants were assessed one week after the programme was completed (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).
measure: 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).
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).
measure: Static Balance at baseline.
time frame: The participants were assessed one week before starting the program (week #0).
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.
measure: Change from baseline Static Balance at 15 weeks.
time frame: The participants were assessed one week after the programme was completed (week #15).
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.
measure: 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).
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.
measure: Change from baseline Motor Impairment at 15 weeks.
time frame: The participants were assessed one week after the programme was completed (week #15).
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.
measure: 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).
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.
arm group label: Pilates
arm group type: Experimental
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 group label: Conventional Exercise
arm group type: Active Comparator
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: Pilates
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.
arm group label: Pilates
intervention type: Other
intervention name: Conventional Exercise
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.
arm group label: Conventional Exercise
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: No
last name: José María Cancela-Carral, Ph.D.
role: Study Director
affiliation: University of Vigo
citation: Abbruzzese G, Marchese R, Avanzino L, Pelosin E. Rehabilitation for Parkinson's disease: Current outlook and future challenges. Parkinsonism Relat Disord. 2016 Jan;22 Suppl 1:S60-4. doi: 10.1016/j.parkreldis.2015.09.005. Epub 2015 Sep 3.
PMID: 26360239
citation: Ayan C, Cancela JM, Gutierrez-Santiago A, Prieto I. Effects of two different exercise programs on gait parameters in individuals with Parkinson's disease: a pilot study. Gait Posture. 2014;39(1):648-51. doi: 10.1016/j.gaitpost.2013.08.019. Epub 2013 Sep 7.
PMID: 24021522
citation: Di Giulio I, St George RJ, Kalliolia E, Peters AL, Limousin P, Day BL. Maintaining balance against force perturbations: impaired mechanisms unresponsive to levodopa in Parkinson's disease. J Neurophysiol. 2016 Aug 1;116(2):493-502. doi: 10.1152/jn.00996.2015. Epub 2016 Apr 20.
PMID: 27098030
citation: Dibble LE, Addison O, Papa E. The effects of exercise on balance in persons with Parkinson's disease: a systematic review across the disability spectrum. J Neurol Phys Ther. 2009 Mar;33(1):14-26. doi: 10.1097/NPT.0b013e3181990fcc.
PMID: 19265767
citation: Johnson L, Putrino D, James I, Rodrigues J, Stell R, Thickbroom G, Mastaglia FL. The effects of a supervised Pilates training program on balance in Parkinson's disease. Advances in Parkinson Disease 2: 58-61, 2013.
citation: Kalron A, Rosenblum U, Frid L, Achiron A. Pilates exercise training vs. physical therapy for improving walking and balance in people with multiple sclerosis: a randomized controlled trial. Clin Rehabil. 2017 Mar;31(3):319-328. doi: 10.1177/0269215516637202. Epub 2016 Jul 10.
PMID: 26951348
citation: Kamioka H, Tsutani K, Katsumata Y, Yoshizaki T, Okuizumi H, Okada S, Park SJ, Kitayuguchi J, Abe T, Mutoh Y. Effectiveness of Pilates exercise: A quality evaluation and summary of systematic reviews based on randomized controlled trials. Complement Ther Med. 2016 Apr;25:1-19. doi: 10.1016/j.ctim.2015.12.018. Epub 2016 Jan 4.
PMID: 27062942
citation: King LA, Horak FB. Delaying mobility disability in people with Parkinson disease using a sensorimotor agility exercise program. Phys Ther. 2009 Apr;89(4):384-93. doi: 10.2522/ptj.20080214. Epub 2009 Feb 19.
PMID: 19228832
citation: Klamroth S, Steib S, Devan S, Pfeifer K. Effects of Exercise Therapy on Postural Instability in Parkinson Disease: A Meta-analysis. J Neurol Phys Ther. 2016 Jan;40(1):3-14. doi: 10.1097/NPT.0000000000000117.
PMID: 26655098
citation: Martinez-Martin P, Rodriguez-Blazquez C, Alvarez-Sanchez M, Arakaki T, Bergareche-Yarza A, Chade A, Garretto N, Gershanik O, Kurtis MM, Martinez-Castrillo JC, Mendoza-Rodriguez A, Moore HP, Rodriguez-Violante M, Singer C, Tilley BC, Huang J, Stebbins GT, Goetz CG. Expanded and independent validation of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). J Neurol. 2013 Jan;260(1):228-36. doi: 10.1007/s00415-012-6624-1. Epub 2012 Aug 5.
PMID: 22865238
citation: Santamato A, Ranieri M, Panza F, Zoccolella S, Frisardi V, Solfrizzi V, Amoruso MT, Amoruso L, Fiore P. Botulinum toxin type A and a rehabilitation program in the treatment of Pisa syndrome in Parkinson's disease. J Neurol. 2010 Jan;257(1):139-41. doi: 10.1007/s00415-009-5310-4. No abstract available.
PMID: 19763384
citation: Ayan C, Varela S, Vila MH, Seijo-Martinez M, Cancela JM. Treadmill training combined with water and land-based exercise programs: Effects on Parkinson's disease patients. NeuroRehabilitation. 2016 Jun 30;39(2):295-9. doi: 10.3233/NRE-161360.
PMID: 27372364
citation: Bergamin M, Gobbo S, Bullo V, Zanotto T, Vendramin B, Duregon F, Cugusi L, Camozzi V, Zaccaria M, Neunhaeuserer D, Ermolao A. Effects of a Pilates exercise program on muscle strength, postural control and body composition: results from a pilot study in a group of post-menopausal women. Age (Dordr). 2015 Dec;37(6):118. doi: 10.1007/s11357-015-9852-3. Epub 2015 Nov 15.
PMID: 26578458
citation: Bird ML, Hill KD, Fell JW. A randomized controlled study investigating static and dynamic balance in older adults after training with Pilates. Arch Phys Med Rehabil. 2012 Jan;93(1):43-9. doi: 10.1016/j.apmr.2011.08.005. Epub 2011 Oct 5.
PMID: 21975148
citation: Cattaneo D, Jonsdottir J, Regola A, Carabalona R. Stabilometric assessment of context dependent balance recovery in persons with multiple sclerosis: a randomized controlled study. J Neuroeng Rehabil. 2014 Jun 10;11:100. doi: 10.1186/1743-0003-11-100.
PMID: 24912561
citation: Bang DH, Cho HS. Effect of body awareness training on balance and walking ability in chronic stroke patients: a randomized controlled trial. J Phys Ther Sci. 2016 Jan;28(1):198-201. doi: 10.1589/jpts.2016.198. Epub 2016 Jan 30.
PMID: 26957757
citation: de Oliveira Francisco C, de Almeida Fagundes A, Gorges B. Effects of Pilates method in elderly people: Systematic review of randomized controlled trials. J Bodyw Mov Ther. 2015 Jul;19(3):500-8. doi: 10.1016/j.jbmt.2015.03.003. Epub 2015 Mar 20.
PMID: 26118523
citation: Donath L, Roth R, Hurlimann C, Zahner L, Faude O. Pilates vs. Balance Training in Health Community-Dwelling Seniors: a 3-arm, Randomized Controlled Trial. Int J Sports Med. 2016 Mar;37(3):202-10. doi: 10.1055/s-0035-1559695. Epub 2015 Dec 2.
PMID: 26630547
citation: Guclu-Gunduz A, Citaker S, Irkec C, Nazliel B, Batur-Caglayan HZ. The effects of pilates on balance, mobility and strength in patients with multiple sclerosis. NeuroRehabilitation. 2014;34(2):337-42. doi: 10.3233/NRE-130957.
PMID: 23949064
citation: King LA, Salarian A, Mancini M, Priest KC, Nutt J, Serdar A, Wilhelm J, Schlimgen J, Smith M, Horak FB. Exploring outcome measures for exercise intervention in people with Parkinson's disease. Parkinsons Dis. 2013;2013:572134. doi: 10.1155/2013/572134. Epub 2013 Apr 30.
PMID: 23738230
citation: Kucuk F, Kara B, Poyraz EC, Idiman E. Improvements in cognition, quality of life, and physical performance with clinical Pilates in multiple sclerosis: a randomized controlled trial. J Phys Ther Sci. 2016 Mar;28(3):761-8. doi: 10.1589/jpts.28.761. Epub 2016 Mar 31.
PMID: 27134355
citation: La Touche R, Escalante K, Linares MT. Treating non-specific chronic low back pain through the Pilates Method. J Bodyw Mov Ther. 2008 Oct;12(4):364-70. doi: 10.1016/j.jbmt.2007.11.004. Epub 2008 Feb 1.
PMID: 19083695
citation: Lange C, Unnithan VB, Larkam E, Latta PM. Maximizing the benefits of Pilates-inspired exercise for learning functional motor skills. Journal of Bodywork and Movement Therapies 4: 99-108, 2000.
citation: Markovic G, Sarabon N, Greblo Z, Krizanic V. Effects of feedback-based balance and core resistance training vs. Pilates training on balance and muscle function in older women: a randomized-controlled trial. Arch Gerontol Geriatr. 2015 Sep-Oct;61(2):117-23. doi: 10.1016/j.archger.2015.05.009. Epub 2015 May 27.
PMID: 26036209
citation: Phrompaet S, Paungmali A, Pirunsan U, Sitilertpisan P. Effects of pilates training on lumbo-pelvic stability and flexibility. Asian J Sports Med. 2011 Mar;2(1):16-22. doi: 10.5812/asjsm.34822.
PMID: 22375213
citation: Schmitz-Hubsch T, Pyfer D, Kielwein K, Fimmers R, Klockgether T, Wullner U. Qigong exercise for the symptoms of Parkinson's disease: a randomized, controlled pilot study. Mov Disord. 2006 Apr;21(4):543-8. doi: 10.1002/mds.20705.
PMID: 16229022
citation: Tolnai N, Szabo Z, Koteles F, Szabo A. Physical and psychological benefits of once-a-week Pilates exercises in young sedentary women: A 10-week longitudinal study. Physiol Behav. 2016 Sep 1;163:211-218. doi: 10.1016/j.physbeh.2016.05.025. Epub 2016 May 16.
PMID: 27195456
citation: Volpe D, Giantin MG, Maestri R, Frazzitta G. Comparing the effects of hydrotherapy and land-based therapy on balance in patients with Parkinson's disease: a randomized controlled pilot study. Clin Rehabil. 2014 Dec;28(12):1210-7. doi: 10.1177/0269215514536060. Epub 2014 Jun 3.
PMID: 24895382
citation: Wells C, Kolt GS, Marshall P, Bialocerkowski A. Indications, benefits, and risks of Pilates exercise for people with chronic low back pain: a Delphi survey of Pilates-trained physical therapists. Phys Ther. 2014 Jun;94(6):806-17. doi: 10.2522/ptj.20130568. Epub 2014 Apr 3.
PMID: 24700138
citation: Wong-Yu IS, Mak MK. Multi-dimensional balance training programme improves balance and gait performance in people with Parkinson's disease: A pragmatic randomized controlled trial with 12-month follow-up. Parkinsonism Relat Disord. 2015 Jun;21(6):615-21. doi: 10.1016/j.parkreldis.2015.03.022. Epub 2015 Mar 31.
PMID: 25899544
responsible party type: Principal Investigator
investigator affiliation: University of Vigo
investigator full name: Gustavo Rodríguez Fuentes
investigator title: Ph.D.
mesh term: Parkinson Disease
sharing ipd: No