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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01701128
• Other study ID #: TTPD-2011
• Status: Terminated
• Phase: N/A
• First received: September 18, 2012
• Last updated: October 3, 2012
• Start date: October 2010
• Est. completion date: March 2012

Study information

• Verified date: September 2012
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: March 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of idiopathic Parkinson's disease

• Stage of II or less on Hoehn and Yahr scale

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Walking on treadmill
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.
• Walking on treadmill
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, the TT velocity was increased by 0,2 km/h or the incline of the walking surface of TT was increased by 1% alternately when the progression criteria were met.
• Control group
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

Locations

Country	Name	City	State
Canada	Laval University	Quebec
Canada	Quebec Memory and Motor Skills Disorders Research Center	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Gait speed	This measure was recorded using the GAITrite system	Baseline, 3 and 6 months	Yes
Primary	Change in Endurance walking	This measure was recorded using the 6-minutes walk test	Baseline, 3 and 6 months	Yes
Primary	Change in Quality of life	This measure was recorded using PDQ-39	Baseline, 3 and 6 months	Yes
Secondary	Change in Postural Balance	This measure was recorded using force platform PRO Balance Master®	Baseline, 3 and 6 months	Yes
Secondary	Change in Spatiotemporal parameters of walking	This measure was recorded using the GAITrite system	Baseline, 3 and 6 months	Yes
Secondary	Change in Cognitive impairment	This measure was recorded using Mini-Mental State Examination	Baseline, 3 and 6 months	Yes
Secondary	Change in Fear of falling	This measure was recorded using the ABC Scale	Baseline, 3 and 6 months	Yes
Secondary	Change in Depression and anxiety level	This measure was recorded using BDI-II	Baseline, 3 and 6 months	Yes
Secondary	Change in Effects of symptoms and motor impairment	This measure was recorded using the UPDRS	Baseline, 3 and 6 months	Yes