Clinical trial NCT02476266: Two Resistance Training Protocols to Reduce the Risk of Falls in Parkinson's Disease
Official title: Power Training to Reduce Falls in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Accidental Falls
Keywords: resistance training
strength training
balance
muscle strength
Lead sponsor: Sun Life Financial Movement Disorders Research and Rehabilitation Centre
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Parkinson's disease (PD) is a chronic neurodegenerative disorder that is characterized by a multitude of symptoms. Impairments in balance, muscle deficits and increased risk of falls are commonly experienced in PD.The purpose of this study is to investigate the effects of two different resistance training programs on improving balance and muscular strength to thereby reduce the risk of falls in those with PD. This study will randomize individuals to one of two groups, a power training group, or a strength training group. Both interventional groups will participate in 12 weeks of resistance training, two times per week for an hour each exercise session.

Detailed description: Parkinson's disease (PD) is a neurodegenerative disorder that results in multiple hallmark symptoms, such as balance impairments, postural instability and muscular deficits. These symptoms, in combination with a deficient sensory-perceptual integration system, put individuals with PD at a higher risk of falls and fractures, compared to healthy older adults. With the expected rise in PD diagnosis, this will place an unprecedented burden on the Canadian healthcare system due to increased hospitalizations, surgeries, placement into long term care facilities, and rehabilitation. Improving symptom severity and delaying disease progression through rehabilitation strategies that improve balance and muscular deficits, can decrease falling risk in individuals with PD, potentially alleviating the projected burden on the healthcare system. For these reasons it is imperative to have the ability to directly measure the degree to which individuals with PD are at risk of experiencing falls through objective techniques.

Purpose: Therefore the purpose of this study is to examine the effects of two different forms of resistance training (RT) to improve the muscular deficits experienced, as well to improve the balance impairments experienced as it has been suggested that RT is able to do this not only in healthy older adults but in those with PD as well. The two RT programs that will be investigated are a conventional strength training (ST) program and a high velocity strength training, known as power training (PT) program.

Objective/Aim: The objective of this study is to identify if ST or PT is a more effective rehabilitation program to improving muscle strength and power, balance measures and reducing the risk of falls. Due to the nature of the PT intervention it is hypothesized that these individuals will experience the greatest improvements in outcome measures.

Methods/Design: This study will be a double blind randomized controlled trial. Participants will be blinded to group allocation except for the control group, however those in the interventional group will only be informed that they are participating in a RT program. The primary investigator will only collect measures that are considered to be objective at follow up time points. Pre-intervention measures will all be collected prior to randomization into group allocations. The assessor of disease severity will also be blinded to group allocation.

Participants will be randomized to one of three groups: i) a control group (to account for normal disease progression for the duration of the intervention); ii) ST group and iii) PT group.

The intervention will be a total of 12 weeks long, where participants will come in two days per week for an hour long session each day, for a total of 24 session.

Participants randomized to the ST group will complete three sets of 8-10 repetitions at 70% of their one repetition maximum (1-RM), as determined during their pre-test. Those randomized to the PT group will complete three sets of 12-15 repetitions at 40% of their 1-RM, as determined during their pre-test. Both programs involve individualized exercise prescriptions based on the results of their predicted 1-RM. This program will be designed by a Canadian Society for Exercise Physiology Certified Exercise Physiologist, who has the knowledge and ability to safely test and prescribe exercise to individuals with chronic conditions. Both programs will be progressive in nature, in that as each individual is able to complete the last set, for two consecutive training sessions at the higher end of the range of repetitions (i.e. for the ST group 10 or more repetitions), the next session their weight will be increased by 5%. Upon completion participants will complete all outcome measures again. These measures will be completed during a wash out period at 3 months and 6 months post intervention to investigate the potential long term effects of these rehabilitation programs, and if either is more advantageous in the long term.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with idiopathic PD by a Neurologist
* Able to stand two minutes, unassisted
* Able to understand English instructions
* Signed Physical Activity Readiness Medical Examination (PARmed-X) by physician

Exclusion Criteria:

* a neurological disease other than PD
* peripheral neuropathy
* physical impairments that would prevent participation in the muscular strength testing
* uncontrolled hypertension

Primary outcomes:
measure: Lean-and-Release Perturbation Technique.
timeFrame: Change in muscle activity, compensatory postural responses from baseline to 12 weeks.
measure: Lean-and-Release Perturbation Technique.
timeFrame: Change in muscle activity, compensatory postural responses from 12 weeks to three month wash out
measure: Lean-and-Release Perturbation Technique.
timeFrame: Change in muscle activity, compensatory postural responses from 12 weeks to six month wash out
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale Motor Subsection (UPDRS III)
timeFrame: Change in motor severity from baseline to 12 weeks
measure: Unified Parkinson's Disease Rating Scale Motor Subsection (UPDRS III)
timeFrame: Change in motor severity from 12 weeks to three month wash out
measure: Unified Parkinson's Disease Rating Scale Motor Subsection (UPDRS III)
timeFrame: Change in motor severity from 12 weeks to six month wash out
measure: Gait Measurement
timeFrame: Changes in gait measures from baseline to 12 weeks
measure: Gait Measurement
timeFrame: Changes in gait measures from 12 weeks to three month wash out
measure: Gait Measurement
timeFrame: Changes in gait measures from 12 weeks to six month wash out
measure: Balance Measurement
timeFrame: Changes in postural stability measures from baseline to 12 weeks
measure: Balance Measurement
timeFrame: Changes in postural stability measures from 12 weeks to three month wash out
measure: Balance Measurement
timeFrame: Changes in postural stability measures from 12 weeks to six month wash out
measure: Muscular Strength and Power Assessment
timeFrame: Changes in muscle strength measures from baseline to 12 weeks
measure: Muscular Strength and Power Assessment
timeFrame: Changes in muscle strength measures from 12 weeks to three month wash out
measure: Muscular Strength and Power Assessment
timeFrame: Changes in muscle strength measures from 12 weeks to six month wash out
measure: Timed Up and Go (TUG)
timeFrame: Changes in time and gait measures from baseline to 12 weeks
measure: Timed Up and Go (TUG)
timeFrame: Changes in time and gait measures from 12 weeks to three month wash out
measure: Timed Up and Go (TUG)
timeFrame: Changes in time and gait measures from 12 weeks to six month wash out
measure: Thirty Second Sit to Stand
timeFrame: Change in number of sit to stands completed from baseline to 12 weeks
measure: Thirty Second Sit to Stand
timeFrame: Change in number of sit to stands completed from 12 weeks to three month wash out
measure: Thirty Second Sit to Stand
timeFrame: Change in number of sit to stands completed from 12 weeks to six month wash out
Other outcomes:
measure: Parkinson's disease Quality of Life Questionnaire (PDQ-39)
timeFrame: Change in score from baseline to 12 weeks
measure: CHAMPS Questionnaire
timeFrame: Changes in score from baseline to 12 weeks
measure: CHAMPS Questionnaire
timeFrame: Changes in score from 12 weeks three month wash out
measure: CHAMPS Questionnaire
timeFrame: Changes in score from 12 weeks six month wash out
Locations:
city: Waterloo
country: Canada
facility: Sunlife Financial Movement Disorders Research and Rehabilitation Centre- Wilfrid Laurier University
state: Ontario
Study officials:
affiliation: Wilfrid Laurier University
name: Brittany Intzandt, BSc
role: STUDY_DIRECTOR
References:
citation: Glendinning DS, Enoka RM. Motor unit behavior in Parkinson's disease. Phys Ther. 1994 Jan;74(1):61-70. doi: 10.1093/ptj/74.1.61.
citation: Stolze H, Klebe S, Baecker C, Zechlin C, Friege L, Pohle S, Deuschl G. Prevalence of gait disorders in hospitalized neurological patients. Mov Disord. 2005 Jan;20(1):89-94. doi: 10.1002/mds.20266.
citation: Wielinski CL, Erickson-Davis C, Wichmann R, Walde-Douglas M, Parashos SA. Falls and injuries resulting from falls among patients with Parkinson's disease and other parkinsonian syndromes. Mov Disord. 2005 Apr;20(4):410-415. doi: 10.1002/mds.20347.
citation: Newton RU, Murphy AJ, Humphries BJ, Wilson GJ, Kraemer WJ, Hakkinen K. Influence of load and stretch shortening cycle on the kinematics, kinetics and muscle activation that occurs during explosive upper-body movements. Eur J Appl Physiol Occup Physiol. 1997;75(4):333-42. doi: 10.1007/s004210050169.