Parkinson's DiseaseNCT01701128
The Effect of Exercise Training on Gait and Quality of Life in Parkinson's Disease
A study testing Walking on treadmill in people with Parkinson's Disease, run by Laval University at 2 sites in Canada.
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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Walking on treadmill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2010to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease
- Stage of II or less on Hoehn and Yahr scale
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Quebec Memory and Motor Skills Disorders Research Center
Québec, Quebec, G1S 2M5
Laval University
Québec, Quebec, G1V 0A6
About this study
Official title: The Effect of Exercise Training on Gait and Quality of Life in Patients With Early Parkinson's Disease
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
- Being tested
- Walking on treadmill, Control group
- Keywords
- Physical activity, treadmill training, rehabilitation
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking on treadmillOther
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 treadmillOther
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 groupOther
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
| Study group | Role | What they receive |
|---|---|---|
| Speed TT | Experimental | Walk on treadmill with progressive increases in speed Receives: Other: Walking on treadmill |
| Mixed TT | Experimental | Walk on treadmill with progressive increases in speed and incline Receives: Other: Walking on treadmill |
| Control | Active comparator | Light-intensity exercise group, work flexibility and coordination Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait speed
This measure was recorded using the GAITrite system
Measured: Baseline, 3 and 6 months
Change in Endurance walking
This measure was recorded using the 6-minutes walk test
Measured: Baseline, 3 and 6 months
Change in Quality of life
This measure was recorded using PDQ-39
Measured: Baseline, 3 and 6 months
Secondary outcomes (6)
Change in Postural Balance
This measure was recorded using force platform PRO Balance Master®
Measured: Baseline, 3 and 6 months
Change in Spatiotemporal parameters of walking
This measure was recorded using the GAITrite system
Measured: Baseline, 3 and 6 months
Change in Cognitive impairment
This measure was recorded using Mini-Mental State Examination
Measured: Baseline, 3 and 6 months
Change in Fear of falling
This measure was recorded using the ABC Scale
Measured: Baseline, 3 and 6 months
Change in Depression and anxiety level
This measure was recorded using BDI-II
Measured: Baseline, 3 and 6 months
Change in Effects of symptoms and motor impairment
This measure was recorded using the UPDRS
Measured: Baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startOct 2010
- Primary completionJun 2011
- Study completionMar 2012
Why it stopped: Protocol is completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Corbeil, Study director, Laval UniversityAlexandra Nadeau, Study director, Laval UniversityEmmanuelle Pourcher, Principal investigator, Quebec Memory and Motor Skills Disorders Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701128
- Sponsor's protocol ID
- TTPD-2011
- Status last verified
- Sep 2012
- First submitted
- 18 Sep 2012
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38588457Ernst 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.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise Training on Gait and Quality of Life in Patients With Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01701128
- Acronym / sponsor ID
- TTPD-2011
- Conditions
- Parkinson's Disease
- Keywords
- Physical activity, treadmill training, rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol is completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Speed TT | Experimental | Other: Walking on treadmillWalk on treadmill with progressive increases in speed |
| Mixed TT | Experimental | Other: Walking on treadmillWalk on treadmill with progressive increases in speed and incline |
| Control | Active comparator | Other: Control groupLight-intensity exercise group, work flexibility and coordination |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of idiopathic Parkinson's disease
- Stage of II or less on Hoehn and Yahr scale
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking on treadmill3 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. | Other | Speed TT |
| Walking on treadmill3 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. | Other | Mixed TT |
| Control groupTraining 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 | Other | Control |
Primary outcome
Change in Gait speed
Time frame: Baseline, 3 and 6 months
This measure was recorded using the GAITrite system
Change in Endurance walking
Time frame: Baseline, 3 and 6 months
This measure was recorded using the 6-minutes walk test
Change in Quality of life
Time frame: Baseline, 3 and 6 months
This measure was recorded using PDQ-39
6 secondary outcomes
Change in Postural Balance
Time frame: Baseline, 3 and 6 months
Change in Spatiotemporal parameters of walking
Time frame: Baseline, 3 and 6 months
Change in Cognitive impairment
Time frame: Baseline, 3 and 6 months
Change in Fear of falling
Time frame: Baseline, 3 and 6 months
Change in Depression and anxiety level
Time frame: Baseline, 3 and 6 months
Change in Effects of symptoms and motor impairment
Time frame: Baseline, 3 and 6 months
Results and safety
The study was stopped early (reason given: Protocol is completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
- Derived from this study: PubMed 38588457Ernst 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.
- Derived from this study: PubMed 36602886Ernst 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Corbeil study director
Laval University
Alexandra Nadeau study director
Laval University
Emmanuelle Pourcher principal investigator
Quebec Memory and Motor Skills Disorders Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking on treadmill in people with Parkinson's Disease, run by Laval University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Protocol is completed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gait speed (time frame: Baseline, 3 and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01701128, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2012.