Study of Tai Chi Exercise and Balance in Persons With Parkinson's Disease

NCT00611481 | Completed Phase 2 DMC

• 2 other identifiers: R01NS047130NS047130
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

Patients practicing Tai Chi will exhibit significant improvements in primary outcome measures of balance, and secondary outcomes of gait, physical performance, Unified Parkinson's Disease Rating Scale, Falls, muscle strength.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Balance

  3 time points

Secondary Outcomes (1)

• gait, physical performance, Unified Parkinson's Disease Rating Scale, falls, Muscle strength

  3 time points

Study Arms (3)

Tai Chi

EXPERIMENTAL

Behavioral: Tai Chi

B. Strength training

ACTIVE COMPARATOR

Behavioral: Strength training

C. Low-Impact

OTHER

Behavioral: Low-Impact Exercise Control

Interventions

Tai Chi BEHAVIORAL

a set of pre-designed Tai Chi Movements

Tai Chi

Strength training BEHAVIORAL

Lower-extremity strength training exercises

B. Strength training

Low-Impact Exercise Control BEHAVIORAL

a set of chair-based low-impact exercises

C. Low-Impact

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have:
• A diagnosis of idiopathic PD, with a disease severity rating of stage I to IV on the Hoehn and Yahr scale (Hoehn \& Yahr, 1967)
• At least 1 score of 2 or more for at least 1 limb for either the tremor, rigidity, or bradykinesia item of the Unified Parkinson's Disease Rating Scale (UPDRS)
• Stable medication usage
• Not participated in a structured exercise program (i.e., not involved in any routine, organized physical activity program lasting 30 minutes or more per day, such as a gym program or regularly scheduled instructor-led exercise class) in the previous 2 months
• Ability to stand unaided or walk independently; had a personal physician's or neurologist's clearance for participation; and had a willingness to be assigned to intervention conditions.

You may not qualify if:

• Patients who:
• Participate in any other behavioral or pharmacological research study
• Have cognitive decline (Mini-Mental State Examination score, ≤ 24) (Folstein et al., 1975)
• Have self-reported diagnosis of Alzheimer disease or other severe neurological (stage III and IV PD)
• Have evidence of progressive or debilitating conditions (metastatic cancer, severe heart or lung disease, crippling arthritis) or severe losses in vision and hearing that would limit their tolerance to testing and training procedures, that would interfere with study participation
• Are unavailable during the study period.

Sponsors & Collaborators

• Oregon Research Institute: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Related Publications (4)

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  PMID: 38588457 DERIVED

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 DERIVED

• Li F, Harmer P. Economic Evaluation of a Tai Ji Quan Intervention to Reduce Falls in People With Parkinson Disease, Oregon, 2008-2011. Prev Chronic Dis. 2015 Jul 30;12:E120. doi: 10.5888/pcd12.140413.

  PMID: 26226067 DERIVED

• Li F, Harmer P, Fitzgerald K, Eckstrom E, Stock R, Galver J, Maddalozzo G, Batya SS. Tai chi and postural stability in patients with Parkinson's disease. N Engl J Med. 2012 Feb 9;366(6):511-9. doi: 10.1056/NEJMoa1107911.

  PMID: 22316445 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Tai Ji; Resistance Training

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Fuzhong Li, Ph.D.

  Oregon Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2008
• First Posted: February 11, 2008
• Study Start: October 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

US (1)