The Effect of Resistance Training in Parkinson Disease: A Pilot Study

The Effect of Resistance Training on Balance in Patients With Parkinson Disease: A Pilot Study

To investigate if resistance training exercises performed twice a week with or without gym equipment assistance in a 12-week period could improve balance in patients with Parkinson Disease (PD).

Methods: Sixty three patients with idiopathic PD (Hoehn and Yahr stage II - III) and preserved cognitive function will participate in this study. Patients will be randomized among three intervention groups: resistance training with free weights, resistance training with gym equipment and control group. Investigators will use static platform balance variables to assess the primary end-point outcome measures. For the secondary outcomes measures, most common clinical functional balances tests for PD will be applied: Berg Balance Scale (BBS), Mini-BESTest - Balance Evaluation (Mini-BESTest), Timed Up and Go test (TUG) and variables from dynamic posturography.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Gym Group; Other: Free Weights Group; Other: Control Group

Detailed Description

Parkinson's disease is a progressive neurodegenerative disease that affects motor functions and is characterized by bradykinesia, resting tremor, rigidity, and postural instability. Despite of pharmacological treatments, patients remain with deficits in balance, gait, autonomic system functions and cognition which impact on their quality of life.

The effects of resistance training on PD are still controversial when balance and improvement on functional tests are the targets.

Since the results of previous studies about resistance training on balance are still controversial, more interventions are required to address the question if strengthening exercise may improve or not the balance of PD patients. Our exercises will target the trunk, leg and shoulder muscles because of their contribution on patient's posture.

• Study Type: Interventional
• Enrollment (Anticipated): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403010
    • Department of Neurology of University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 50 to 75 years old;
• Hoehn and Yahr stages II or III;
• Idiopathic Parkinson disease diagnosed according to the United Kingdom Parkinson's Disease Society Brain Research Centre Criteria, Institute of Neurology, London;
• Ability to walk independently without walking devices aid;
• Absence of orthopedic injuries or pain in joints that could interfere on training program;
• Stable medication regimen for PD treatment at recruitment stage;
• Mini Mental State Examination Scale (MMSE) ≥ to 27 for literate patients and schooling ≥ of 4 years of formal education;
• No cardiovascular instability;
• No pacemaker, decompensated metabolic disease, vestibular dysfunction, and stroke;
• Availability to come to the clinic twice a week;
• Not participating in other physical rehabilitation programs during and six months prior to the study.

Exclusion Criteria:

• Patients will be excluded if they refuse to participate, do not sign the consent form, have a diagnosis of secondary parkinsonism or present cognitive impairment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gym Group; With gym equipments, twice per week for 12 weeks.	Other: Gym Group; Patients from Gym Group will perform a strengthening program of 45 minutes sessions, twice a week in a 12-week period. The initial load is established as 60% of one-repetition maximum strength test (1RM) applied for each exercise at the beginning of program. Patients will be encouraged to perform 3 sets of 8 to 12 repetitions. All subjects will be instructed to rest for 30-60 second intervals between sets.
Active Comparator: Free Weights Group; With dumbbells, elastics, twice per week for 12 weeks.	Other: Free Weights Group; Patients from Free Weights Group will perform a strengthening program of 45 minutes sessions, twice a week in a 12-week period. The program aim to recruit the same muscles requested in Gym Group. Investigators will apply six different exercises with patients lying supine,standing in stance, sitting and in four points kneeling. All exercises aim to strengthen abdominal muscles, trunk extensors, gluteus, quadriceps and scapula adductors. Patients will perform 3 sets of 8 to 12 repetitions, the load will be offered with dumbbells, elastics with different resistances and anklets.
Placebo Comparator: Control Group; The control group will be instructed to perform stretching exercises at home in the same 12-week period, according to an illustrated booklet.	Other: Control Group; All three groups will be instructed to perform stretching exercises of trunk, leg and shoulder muscles, according to an illustrated booklet. Only the Control Group patients will be instructed to perform stretching exercises at home in the same 12-week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postural sway on Static Posturography	Static Posturography is a technique used to objectively assess postural sway with patients standing still on a fixed platform that measures center of pressure displacement. Tests were standardized such as the feet position, the eye gaze and environment light, with three trials of 60-second test in eyes - open, eyes closed and eyes open in dual task condition. Investigators will analyze the anteroposterior displacement, medial-lateral displacement, area, velocity and path length.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance on Berg Balance Scale	Berg Balance Scale is used to assess balance and falls in elderly using different tasks. It consists of 14 tasks scoring from zero to four, zero means that the patient is unable to perform the task and four means that the task is performed independently.	12 weeks
Balance Evaluation on Mini-BESTest	The Mini-BESTest contains 14 items that assess dynamic balance focusing on anticipatory postural adjustments, postural responses, sensory orientation and stability in gait. Items are scored from 0 to 2 (normal performance in balance).	12 weeks
Functional balance and gait on Timed Up and Go test (TUG)	The TUG test measures individual speed while performing the sequence: rising from a chair, walking for three meters of distance, turning around and returning to the starting position, sitting on a chair. When the examination exceeds 13 seconds, patients have higher risk of falls.	12 weeks
Quality of life on PDQ-39 Questionnaire	The PDQ-39 assess quality of life of Parkinson's disease patients over the last month. Contains 39 items and eight dimensions (Mobility, Activities of daily living, Emotional well-being, Stigma, Social support, Cognitions and Bodily discomfort).	12 weeks
Functional balance on Dynamic Posturography	Dynamic posturography is a quantitative method to assess balance. This system have sensors located below two platforms and measures vertical and horizontal forces produced by the center of gravity during a pre-determined task (sit to stand, tandem walk and step over).	12 weeks

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Study Director: Egberto Reis Barbosa, MD, PhD, Department of Neurology, Clinics Hospital of University of São Paulo Faculty of Medicine, São Paulo, Brazil.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): October 8, 2018

Study Registration Dates

• First Submitted: January 14, 2016
• First Submitted That Met QC Criteria: February 1, 2016
• First Posted (Estimate): February 4, 2016

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Exercise; Resistance Training; Postural Balance
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: Department of Neurology

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED