NCT04585659

Brief Summary

This feasibility study explores a community-based qigong intervention for people with multiple sclerosis (MS). The primary aim is to assess the feasibility of weekly community qigong classes for people with MS. The secondary aim is to explore the effects of qigong on balance, gait, mood, fatigue, and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Feb 2017

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

February 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2018

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
Last Updated

October 14, 2020

Status Verified

September 1, 2020

Enrollment Period

1.1 years

First QC Date

September 2, 2020

Last Update Submit

October 12, 2020

Conditions

Keywords

QigongPragmatic DesignGaitMultiple Sclerosis

Outcome Measures

Primary Outcomes (4)

  • Feasibility Outcome 1: Number of participants recruited for the study

    Ability to recruit and enroll 20 participants with multiple sclerosis (MS) within 8 months.

    8 months

  • Feasibility Outcome 2: Number of participants retained in the study

    Goal to retain 80 percent of participants in the trial.

    10 weeks

  • Feasibility Outcome 3: Percent able to participate in qigong classes

    Participation based on participants' subjective report at week 1, 2, 7 phone check-ins and exit survey. Participants select from the following options: full participation, partial, a little, or none.

    10 weeks

  • Feasibility Outcome 4: Percent attendance in qigong classes

    Class attendance measured by self-report in exit survey and tracked by qigong instructor, with the goal of 70 percent attendance in class.

    10 weeks

Secondary Outcomes (11)

  • Clinical Measure 1: Walking speed assessed by the Timed-25-Foot-Walk Test

    Baseline and 10 weeks

  • Clinical Measure 2: Mobility, balance and walking ability assessed by the Timed-Up-and-Go Test

    Baseline and 10 weeks

  • Clinical Measure 3: Multidirectional mobility assessed by the Four-Square-Step-Test

    Baseline and 10 weeks

  • Clinical Measure 4: Physical and psychological well-being assessed by the Multiple Sclerosis Impact Scale (MSIS-29)

    Baseline and 10 weeks

  • Clinical Measure 5: Impact of multiple sclerosis on walking ability assessed by the Multiple Sclerosis Walking Scale (MSWS-12)

    Baseline and 10 weeks

  • +6 more secondary outcomes

Study Arms (2)

Qigong Intervention

EXPERIMENTAL

60-90 minute community qigong classes, once per week plus at least 10 minutes of home practice

Other: Qigong

Wait-List Control

NO INTERVENTION

Participants asked not to do any qigong, yoga or taichi for 10 weeks. Participants have the option to cross-over to the experimental arm after 10 weeks of no intervention.

Interventions

QigongOTHER

Mind-body movement art that includes specific movements, breath exercises, stretching and meditation.

Also known as: Qi-gong
Qigong Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Living in the Portland Metropolitan Area
  • Self-reported diagnosis of multiple sclerosis (MS - any type)
  • Demonstrated ability to walk 50 feet without assistance
  • Stable on disease-modifying or balance medications three months prior to baseline

You may not qualify if:

  • Pregnant or nursing
  • Participated in qigong, tai chi, or yoga (\>1 month) within six months prior to baseline
  • Had an MS relapse within 30 days prior to baseline.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Natural Medicine, Helfgott Research Institute

Portland, Oregon, 97201, United States

Location

Related Publications (42)

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  • Buttolph L, Wooliscroft L, Bradley R, Zwickey H. Participant Perspectives on Community Qigong for People with Multiple Sclerosis. Integr Med Rep. 2023 Feb 1;2(1):26-34. doi: 10.1089/imr.2022.0079. Epub 2023 Feb 1.

  • Buttolph L, Corn J, Hanes D, Bradley R, Senders A. Community qigong for People with Multiple Sclerosis: A Pragmatic Feasibility Study. J Altern Complement Med. 2021 Jun;27(6):506-514. doi: 10.1089/acm.2020.0481. Epub 2021 Mar 26.

Related Links

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Qigong

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Breathing ExercisesMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Angela Senders, ND, MCR

    Research Investigator and Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2020

First Posted

October 14, 2020

Study Start

February 1, 2017

Primary Completion

March 16, 2018

Study Completion

March 16, 2018

Last Updated

October 14, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations