NCT03006900

Brief Summary

Pilates is becoming popular among the multiple sclerosis (MS) community as an alternative to the more traditional exercise programs. Although somewhat limited, previous research has suggested Pilates may have some beneficial effects in MS. This 12-week, single-blinded, randomized controlled study has one intervention group (Pilates and massage therapy) and one control group (massage therapy only). The primary outcome of interest is the change in walking ability between groups. Secondary outcomes include other measures of physical performance and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

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

December 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

1 year

First QC Date

December 27, 2016

Last Update Submit

June 27, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in distance during the 6-minute walk test

    12 weeks

Secondary Outcomes (12)

  • Change from baseline in balance score for the Fullerton Advanced Balance Scale

    12 weeks

  • Change in sit and reach test score for flexibility

    12 weeks

  • Change from baseline in timed up and go test score

    12 weeks

  • Change from baseline in physical activity level

    12 weeks

  • Change from baseline in maximal isometric knee extension strength

    12 weeks

  • +7 more secondary outcomes

Study Arms (2)

Pilates and massage

EXPERIMENTAL

Pilates (twice per week for 50 minutes) and massage (once per week for one hour)

Other: PilatesOther: Massage

Massage

ACTIVE COMPARATOR

Massage (once per week for one hour)

Other: Massage

Interventions

PilatesOTHER

Pilates

Pilates and massage
MassageOTHER

Massage

MassagePilates and massage

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of multiple sclerosis

You may not qualify if:

  • Expanded Disability Status Scale of 8 or higher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Kinesiology, University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5B2, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exercise Movement TechniquesMassage

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesRehabilitation

Study Officials

  • Charity Evans, PhD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 27, 2016

First Posted

December 30, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

June 28, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations