Strength Training and Different Subtypes of Parkinson´s Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Progressive resistance exercise
Physical Activity
Sponsored by
About this trial
This is an interventional supportive care trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with PD AR-type and Hoehn and Yahr Scale 1-2, (H&Y)
- Do not express any type of dementia
- Able to stand for two min without assistance;
- Able to walk ten metres without assistance.
Exclusion criteria:
- To suffer a neurological disease other than PD.
- Do not meet some of the inclusion criteria.
Sites / Locations
- University School of Sports Medicine, University of Oviedo, Spain.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Progressive resistance exercise (PRE)
Physical Activity
Arm Description
Progressive resistance exercise (PRE) in akinetic-rigid Parkinson's disease patients. Intervention included sixteen PRE training sessions for eight weeks: two sessions per week on non-consecutive days, sixty-seventy min each one.
The control group followed its usual weekly physical activity routine
Outcomes
Primary Outcome Measures
Static posturography through the centre of pressures measurements (CoP).
Secondary Outcome Measures
Gait.
Freezing of gait.
The Movement Disorders Society-Unified Parkinson ́s Disease Rating Scale. (MDS-UPDRS).
The patient- perceived quality of life.
Full Information
NCT ID
NCT02966600
First Posted
November 7, 2016
Last Updated
November 14, 2016
Sponsor
University of Oviedo
1. Study Identification
Unique Protocol Identification Number
NCT02966600
Brief Title
Strength Training and Different Subtypes of Parkinson´s Disease
Official Title
Effects of Progressive Resistance Exercise in Akinetic-rigid Parkinson's Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oviedo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this randomized controlled trial was to assess the impact of progressive resistance exercise (PRE) in PD patients with akinesia and rigidity (AR-subtype). The investigators hypothesized the intervention would have a beneficial effect on the study outcomes.
Detailed Description
Twenty-eight patients with PD AR-type of both sexes, were recruited for this trial. Each participant were assigned randomly to either intervention (N=13) or control (N=15) group.
The intervention group participated in sixteen PRE training sessions for eight weeks: two sessions per week on non-consecutive days, sixty-seventy min each one. The control group followed their usual weekly physical activity routine.
All patients underwent antrophometrical and neuromuscular function assessment (CoP measurements -primary outcomes- and the Ten-Meters Walk Test -TMWT- -secondary outcomes-). In addition, they were asked to provide ratings for the Spanish validated versions of the the Freezing of Gait Questionnaire (FOG-Q, 6-item version) -secondary outcomes-, the 39-item Parkinson ́s disease Questionnaire (PDQ39) -secondary outcomes- and the MDS-UPDRS -secondary outcomes-. Additionally, ratings of perceived exertion (RPE) (Borg >6-20 scale) - secondary outcomes-, were recorded at the end of each PRE training session. Tests were carried out at three times: pre-test (before the training program), post-test (eight weeks after pre-tests, at the end of the training period), and four weeks after the post-test (re-test).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Progressive resistance exercise (PRE)
Arm Type
Experimental
Arm Description
Progressive resistance exercise (PRE) in akinetic-rigid Parkinson's disease patients. Intervention included sixteen PRE training sessions for eight weeks: two sessions per week on non-consecutive days, sixty-seventy min each one.
Arm Title
Physical Activity
Arm Type
No Intervention
Arm Description
The control group followed its usual weekly physical activity routine
Intervention Type
Other
Intervention Name(s)
Progressive resistance exercise
Intervention Description
The intervention group participated in sixteen PRE training sessions for eight weeks: two sessions per week on non-consecutive days, sixty-seventy min each one.
Intervention Type
Other
Intervention Name(s)
Physical Activity
Intervention Description
The control group followed its usual weekly physical activity routine
Primary Outcome Measure Information:
Title
Static posturography through the centre of pressures measurements (CoP).
Time Frame
Eight weeks
Secondary Outcome Measure Information:
Title
Gait.
Time Frame
Eight weeks
Title
Freezing of gait.
Time Frame
Eight weeks
Title
The Movement Disorders Society-Unified Parkinson ́s Disease Rating Scale. (MDS-UPDRS).
Time Frame
Eight weeks
Title
The patient- perceived quality of life.
Time Frame
Eight weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with PD AR-type and Hoehn and Yahr Scale 1-2, (H&Y)
Do not express any type of dementia
Able to stand for two min without assistance;
Able to walk ten metres without assistance.
Exclusion criteria:
To suffer a neurological disease other than PD.
Do not meet some of the inclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Santos, PhD
Organizational Affiliation
University School of Sports Medicine, University of Oviedo, Spain. Performance and Health Group, Department of Physical Education and Sport. Faculty of Sports Sciences and Physical Education, University of A Coruna, Spain.
Official's Role
Principal Investigator
Facility Information:
Facility Name
University School of Sports Medicine, University of Oviedo, Spain.
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33005
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Strength Training and Different Subtypes of Parkinson´s Disease
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