NCT03294031

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable parkinson-disease

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 11, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
Last Updated

September 26, 2017

Status Verified

September 1, 2017

Enrollment Period

5 months

First QC Date

September 18, 2017

Last Update Submit

September 20, 2017

Conditions

Keywords

Parkinson DiseaseNeurodegenerative DisorderPhysical ActivityPilates MethodStabilometer

Outcome Measures

Primary Outcomes (1)

  • 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.

    The participants were assessed one week before starting the program (week #0).

Secondary Outcomes (8)

  • Anthropometric Measurements.

    The participants were assessed one week before starting the program (week #0).

  • Change from baseline Anthropometric Measurements at week 15.

    The participants were assessed one week after the programme was completed (week #15).

  • Change from week 15 Anthropometric Measurements at week 18 follow-up.

    Follow-up assessment was performed four weeks after training ended (week #18).

  • Static Balance at baseline.

    The participants were assessed one week before starting the program (week #0).

  • Change from baseline Static Balance at 15 weeks.

    The participants were assessed one week after the programme was completed (week #15).

  • +3 more secondary outcomes

Study Arms (2)

Pilates

EXPERIMENTAL

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

Conventional Exercise

ACTIVE COMPARATOR

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

Interventions

PilatesOTHER

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.

Pilates

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.

Conventional Exercise

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (30)

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    PMID: 26360239BACKGROUND
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    PMID: 24021522BACKGROUND
  • 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: 27098030BACKGROUND
  • 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: 19265767BACKGROUND
  • 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.

    BACKGROUND
  • 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: 26951348BACKGROUND
  • 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: 27062942BACKGROUND
  • 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: 19228832BACKGROUND
  • 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: 26655098BACKGROUND
  • 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: 22865238BACKGROUND
  • 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: 19763384BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

    RESULT
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Parkinson DiseaseNeurodegenerative DiseasesMotor Activity

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesBehavior

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • José María Cancela-Carral, Ph.D.

    University of Vigo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

September 18, 2017

First Posted

September 26, 2017

Study Start

January 11, 2016

Primary Completion

May 27, 2016

Study Completion

May 27, 2016

Last Updated

September 26, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share