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Parkinson DiseaseNCT03294031

Pilates as an Adjuvant Therapy in Parkinson Disease.

A study testing Pilates and Conventional Exercise in people with Parkinson Disease, run by University of Vigo.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Parkinson Disease
What is being tested?
Pilates and Conventional Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
No sites listed yet
Study dates
11 Jan 2016to 27 May 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: 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.

Being tested
Pilates, Conventional Exercise
Keywords
Parkinson Disease, Neurodegenerative Disorder, Physical Activity, Pilates Method, Stabilometer
Medical subject headings
Parkinson Disease, Neurodegenerative Diseases, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Conventional ExerciseOther

    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.

Study groups in NCT03294031
Study groupRoleWhat they receive
PilatesExperimentalThe 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.
Receives: Other: Pilates
Conventional ExerciseActive comparatorThe 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.
Receives: Other: Conventional Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (8)
  1. 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).

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

  2. 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).

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

  3. 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).

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2017
  2. Study start11 Jan 2016
  3. Primary completion27 May 2016
  4. Study completion27 May 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03294031
Sponsor's protocol ID
2015/484
Status last verified
Sep 2017
First submitted
18 Sep 2017
Last updated
26 Sep 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26360239
  • 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.

    PubMed 24021522
  • 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.

    PubMed 27098030
  • 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.

    PubMed 19265767
  • 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.

  • 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.

    PubMed 26951348
  • 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.

    PubMed 27062942
  • 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.

    PubMed 19228832
  • 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.

    PubMed 26655098
  • 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.

    PubMed 22865238
  • 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.

    PubMed 19763384
  • 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.

    PubMed 27372364
  • 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.

    PubMed 26578458
  • 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.

    PubMed 21975148
  • 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.

    PubMed 24912561

Questions about this trial

What is this clinical trial studying?

A study testing Pilates and Conventional Exercise in people with Parkinson Disease, run by University of Vigo.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Motor impairment. (time frame: The participants were assessed one week before starting the program (week #0).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03294031, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2017.

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