The Effect of Exercise Training on Gait and Quality of Life in Parkinson's Disease

NCT01701128 | Terminated DMC

• 1 other identifier: TTPD-2011
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

The project aims to evaluate the effects of 24 weeks of treadmill training (TT), with and without a strengthening component, on functional mobility, gait and quality of life in patients with Parkinson's disease (PD). The rationale for a study of this type stems from the hypothesis that treadmill training may act as an external "pacemaker" and enhance some properties of gait. There is a need for larger scale randomized controlled trials comparing the effects of treadmill training to control groups that receive similar amounts of attention. To date, no study has combined TT and muscle strengthening, likely the optimal form of therapy. A kinesiologist supervises the training, 3 times per week, for a total of 72 one-hour exercise sessions. It is hypothesized that at the end of 6 months, treadmill training will considerably improve walking parameters and the well being of people with PD.

Conditions

Parkinson's Disease

Keywords

Physical activity, treadmill training, rehabilitation

Outcome Measures

Primary Outcomes (3)

• Change in Gait speed

  This measure was recorded using the GAITrite system

  Baseline, 3 and 6 months

• Change in Endurance walking

  This measure was recorded using the 6-minutes walk test

  Baseline, 3 and 6 months

• Change in Quality of life

  This measure was recorded using PDQ-39

  Baseline, 3 and 6 months

Secondary Outcomes (6)

• Change in Postural Balance

  Baseline, 3 and 6 months

• Change in Spatiotemporal parameters of walking

  Baseline, 3 and 6 months

• Change in Cognitive impairment

  Baseline, 3 and 6 months

• Change in Fear of falling

  Baseline, 3 and 6 months

• Change in Depression and anxiety level

  Baseline, 3 and 6 months

Study Arms (3)

Speed TT

EXPERIMENTAL

Walk on treadmill with progressive increases in speed

Other: Walking on treadmill

Mixed TT

EXPERIMENTAL

Walk on treadmill with progressive increases in speed and incline

Other: Walking on treadmill

Control

ACTIVE COMPARATOR

Light-intensity exercise group, work flexibility and coordination

Other: Control group

Interventions

Walking on treadmill OTHER

3 sessions/week, 24 weeks. The heart rate does not exceed 75% of maximum heart rate (220-age) of the participant and that blood pressure does not exceed 250/115 mmHg. During the first week, the TT velocity was adjusted to 80% of preferential walking speed of the participant. The following week, the participant was encouraged to reach 90% and 100% in the third week. From the fourth week, subjects in the Speed TT had an increase in speed, depending on exercise tolerance of each participant. The TT velocity was increased by 0,2 km/h when the participant reached criteria.

Speed TT

Control group OTHER

Training of the control group was characterized by light intensity exercises. For the first three months, participants performed regular exercise involving full range of motion to enhance their flexibility. For the last three months of the training programme, participants learned elements of Tai Chi and rhythmic movements of latin dance. Participants attended two 1-h supervised sessions per week and were asked to perform each week a third session at home, based on instructions in a document offered to the control group participants

Control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic Parkinson's disease
• Stage of II or less on Hoehn and Yahr scale

You may not qualify if:

• Having musculoskeletal impairments or having excessive pain in any joint that could limit participation in exercise program
• Dementia (MMSE\<24)
• Having balance problems
• Live beyond 45 minutes from Laval University

Sponsors & Collaborators

• Laval University: lead

Study Sites (2)

Quebec Memory and Motor Skills Disorders Research Center

Québec, Quebec, G1S 2M5, Canada

Location

Laval University

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (2)

• 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

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Philippe Corbeil

  Laval University

  STUDY DIRECTOR

• Alexandra Nadeau

  Laval University

  STUDY DIRECTOR

• Emmanuelle Pourcher

  Quebec Memory and Motor Skills Disorders Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2012
• First Posted: October 4, 2012
• Study Start: October 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: March 1, 2012
• Last Updated: October 4, 2012

Record last verified: 2012-09

Locations

CA (2)