Effects of a program of strengthening exercise in subjects with Parkinson's disease

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-4g7q2c
• Date of registration: 16/07/2012
• Primary sponsor: Universidade Federal de Minas Gerais-UFMG - Belo Horizonte, MG, Brazil
• Public title: Effects of a program of strengthening exercise in subjects with Parkinson's disease
• Scientific title: Strengthening exercise in individuals with parkinson´s disease: A randomised trial
• Date of first enrolment: 15/11/2011
• Target sample size: 32
• Recruitment status: recruitment completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-4g7q2c/
• Study design: Therapeutic, randomized, parallel, single blinded, with two arms clinical trial

Countries of recruitment

Brazil

Contacts

• Name: Lidiane Lima
• Affiliation: Universidade Federal de Minas Gerais-UFMG

• Name: Lidiane Lima
• Affiliation: Universidade Federal de Minas Gerais-UFMG

Key inclusion & exclusion criteria

Inclusion criteria: Are older than 50 years of age;
Have a diagnosis of PD;
In stages I to IV of the Disability Stages of Hoehn & Yahr;
Be stable use of anti-parkinsonian;
Have good comprehension (assessed using the Mini Mental State Examination score);
Signing the informed consent
Exclusion criteria: Adverse medical conditions that may prevent participation in the proposed protocols as decompensated hypertension, neurological diseases or other rheumatic diseases of any kind;
Individuals who are in physical therapy for at least 02 months before the randomisation procedure.

Age minimum: 50Y
Age maximum: 90Y
Gender: -

Health Condition(s) or Problem(s) studied

Parkinson´s disease
G20

Intervention(s)

The participants will receive training for 10 weeks at a frequency of three times per week and duration of 40 minutes each session. Sixteen will be recruited for each group. Physical therapists will be trained prior to the standardization of training protocol. The experimental group will receive the protocol of lower limb strengthening exercises under the supervision of a physiotherapist, while the control group will do the same exercises at home and without external load.
Program of muscle strengthening:
The following lower limb muscle groups will be trained: flexors, extensors, hip adductors and abductors, knee flexors and extensors; dorsoflexores and the ankle plantar flexors. Each session will include: (1) 10 minute warm up (calisthenics, stretching and light exercises range of motion), (2): 20 minutes of muscle strength training (using the principles of progressive load training) for the muscle groups mentioned above. The maximum resistance will be evaluated every two weeks in patients. (3): Duration of cooling (10 minutes of relaxation exercises and light stretching

Training program at home:
The control group will receive the same exercise program with frequency and number of repetitions similar to the experimental group, except that there is no external load applied with weights. Individuals assigned to this group will carry out such an exercise program at home and will be contacted by phone weekly to monitor the realization of them. In addition, an agenda will be delivered to each individual where it will be asked to write the days of the week conducting the exercises.

Primary Outcome(s)

Expected Outcome: Increased muscle strength.

Measures of muscle strength will be obtained with a manual dynamometer. Will be assessed maximal isometric force, supported by five seconds, the following muscle groups: the dorsal and plantar flexors and extensors and flexors of the knee and hip. This instrument provides measurements in kilograms-force (kgf), which will be converted to Newton-meters (Nm) with correction of gravity.
The proposed measure will be obtained before, immediately after intervention and one month after the intervention

Secondary Outcome(s)

Expected outcome: improved balance and gait parameters (walking speed, cadence, step length).
The balance will be assessed using the Berg Bal ¬ ance Scale (BBS). It comprises 14 items that measure the static and dynamic balance in different situations.
The running is evaluated by means of equipment GAITRite ® system. The GAITRite ® system consists of a mat with electronic sensors positioned to capture spatiotemporal measures of gait.
All the proposed measures shall be obtained before, immediately after the intervention and one month after the intervention.

Expected outcome: improvement of clinical and functional performance and quality of life of individuals with PD.
The UPDRS is a scale clinical evaluation of patients with PD and has four domains (mental activity, behavior and mood, activities of daily living, motor exploration and complications of drug treatment) which are evaluated in a semi-quantitative.
All the proposed measures shall be obtained before, immediately after the intervention and one month after the intervention.

The PDQ-39 indicates the overall impact of PD on the well-being and health of the individual as well as being sensitive to the effects of different treatments.

Secondary ID(s)

CAAE: 0329.0.203.000-10

Prot: 329-10

Source(s) of Monetary Support

Fundação de Amparo à pesquisa do estado de Minas Gerais - Belo Horizonte, MG, Brazil

Secondary Sponsor(s)

Universidade Federal de Minas Gerais-UFMG - Belo Horizonte, MG, Brazil