Effects of Home-based High-speed Bodyweight Resistance Training in Individual With Parkinson's Disease

NCT06646523 | Recruiting

• 1 other identifier: CAAE: 68350023.7.0000.5149
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Exercises that involve increasing the speed of movements are beneficial for individuals with Parkinson's disease (PD) and have the potential to reduce bradykinesia and improve mobility. High-speed bodyweight resistance training is a treatment that involves increasing speed considered accessible and viable as it can be performed at any time and place, including at home. This treatment has already shown benefits in the elderly individuals, however no studies were found in individuals with PD. Therefore, the primary aim of this study will be to investigate the effects of home-based and remotely supervised high-speed bodyweight resistance training in reducing bradykinesia in individuals with PD. The secondary aim will be to investigate the effects of home-based and remotely supervised high-speed bodyweight resistance training in improving mobility, muscle power, dynamic balance, and quality of life in this population. A randomized controlled trial will be carried out with concealed allocation, blinded assessments, and intention-to-treat analysis. Altogether, 46 individuals with PD (age ≥ 50 years old, who are bradykinetics and sedentary or insufficiently active will be included. Participants will be randomly assigned to either an experimental group (high-speed bodyweight resistance training) or a control group (bodyweight intervention, usual speed). Both groups will perform a home-based and remotely supervised intervention, consisting of 60-min individual sessions, three times per week over 12 weeks, with a trained physiotherapist. Primary outcomes is bradykinesia of the lower limbs. Secondary outcomes are mobility, muscle power, dynamic balance, and quality of life. The findings of this trial have the potential to provide important insights regarding the effects of high-speed bodyweight resistance training in reducing bradykinesia and improving mobility in individuals with PD. High-speed bodyweight resistance training does not use any type of external resistance and can be performed anywhere and at any time. In addition, it can be performed at home through telemonitoring, reducing time and costs of transport, making it quite feasible and accessible for individuals from different social and economic backgrounds which increases the feasibility of reproducing their findings in clinical practice.

Conditions

Parkinson Disease

Keywords

Exercise; Bradykinesia; Mobility; Rehabilitation; Parkinson disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Bradykinesia - Unified Parkinson's Disease Rating Scale

  Bradykinesia of the lower limbs will be measured using item 3.8 (Leg Agility), assessed bilaterally (right and left), and item 3.14 (Global Spontaneity of Movement - Body Bradykinesia) of the motor examination of the MDS-UPDRS. Each score ranges from 0 to 4, with 0 indicating normal function and 4 indicating severe impairment. The primary bradykinesia outcome will be calculated as the sum of the bilateral scores for item 3.8 and the score for item 3.14, resulting in a composite score ranging from 0 to 12. Higher scores indicate more severe bradykinesia.

  At baseline, 12 weeks post-intervention, and at 4-week follow-up

Secondary Outcomes (4)

• Change from baseline in Mobility - 10-m walk test

  At baseline, 12 weeks post-intervention, and at 4-week follow-up

• Change from baseline in Muscle power - Five Time Sit to Stand

  At baseline, 12 weeks post-intervention, and at 4-week follow-up

• Change from baseline in Dynamic balance - Mini-Balance Evaluation System's Test

  At baseline, 12 weeks post-intervention, and at 4-week follow-up

• Change from baseline in Quality of life - Parkinson's Disease Questionnaire-39

  At baseline, 12 weeks post-intervention, and at 4-week follow-up

Study Arms (2)

High-speed bodyweight resistance training

EXPERIMENTAL

The participants of the experimental group (high-speed bodyweight resistance training) will receive a home-based intervention that will include 5 minutes of warm-up (free active movements of trunk and lower limbs), followed by 50 min of exercises more targeted to the lower limb muscles, and by 5 minutes of cool-down (lower limb muscle stretching and relaxation breathing exercise). The experimental intervention will be performed at maximum speed. During the initial home visit, the speed at which the participant can perform one set of each exercise at maximum speed will be timed. Speed-based progression will be determined every four weeks by increasing the number of repetitions in each set of exercises performed during subsequent home visits.

Other: High-speed bodyweight resistance training

Control group (Bodyweight intervention, usual speed)

SHAM COMPARATOR

The participants of the control group (Bodyweight intervention, usual speed) will also receive a home-based intervention that will include 5 minutes of warm-up (free active movements of trunk and lower limbs), followed by 50 min of exercises more targeted to the lower limb muscles, and by 5 minutes of cool-down (lower limb muscle stretching and relaxation breathing exercise). The control intervention will be performed at the usual speed. The same procedures that will be carried out to determine the maximum speed in the experimental group will be used to determine the usual speed in the control group. There will be no progression in the speed of performing the exercises. However, participants in the control group will also receive a home visit from the main researcher every four weeks to avoid bias related to the amount of attention given to participants in the experimental group.

Other: Control group (Bodyweight intervention, usual speed)

Interventions

High-speed bodyweight resistance training OTHER

The participants of the experimental group (high-speed bodyweight resistance training) will receive a home-based intervention that will include 5 minutes of warm-up (free active movements of trunk and lower limbs), followed by 50 min of exercises more targeted to the lower limb muscles, and by 5 minutes of cool-down (lower limb muscle stretching and relaxation breathing exercise). The experimental intervention will be performed at maximum speed. During the initial home visit, the speed at which the participant can perform one set of each exercise at maximum speed will be timed. Speed-based progression will be determined every four weeks by increasing the number of repetitions in each set of exercises performed during subsequent home visits.

High-speed bodyweight resistance training

Control group (Bodyweight intervention, usual speed) OTHER

The participants of the control group (Bodyweight intervention, usual speed) will also receive a home-based intervention that will include 5 minutes of warm-up (free active movements of trunk and lower limbs), followed by 50 min of exercises more targeted to the lower limb muscles, and by 5 minutes of cool-down (lower limb muscle stretching and relaxation breathing exercise). The control intervention will be performed at the usual speed. The same procedures that will be carried out to determine the maximum speed in the experimental group will be used to determine the usual speed in the control group. There will be no progression in the speed of performing the exercises. However, participants in the control group will also receive a home visit from the main researcher every four weeks to avoid bias related to the amount of attention given to participants in the experimental group.

Control group (Bodyweight intervention, usual speed)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥50 years old;
• Parkinson's disease diagnosed by a neurologista;
• classified between stages 1-3 of the modified Hoehn \& Yahr Scale;
• present bradykinesia identified by items 3.8 (Leg Agility) and/or 3.14 (Global Spontaneity of Movement - Body Bradykinesia) of the motor examination of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) with a minimum score of 1 out of 4 points in at least one of the items;
• taking antiparkinsonian medication, and who have been medically stable
• are classified as inactive or insufficiently active; have ability to walk independently without assistive devices; and have written medical permission to allow them to participate in the study. The Centers for Disease Control and Prevention classification will be used to determine if an individual is inactive or insufficiently active. Participants will be asked about the exercises they performed most often over the last 4 weeks, including their frequency and duration. Individuals who report that they have performed physical exercise over the last month at least five times per week for more than 30 min at a moderate intensity or at least three times per week for at least 20 min at a vigorous intensity will be classified as having moderate or vigorous exercise levels, respectively. Individuals who report not having practiced any exercise over the last month will be classified as inactive. Those who report doing physical exercise over the last month that is not classified as vigorous or moderate intensity will be classified as insufficiently active.

You may not qualify if:

• cognitive impairments as determined by cutoff scores (in points) of the Mini-Mental Status Examination according to education level reference;
• any other neurological, musculoskeletal, cardiovascular, or respiratory disorders that could affect their ability to perform the tests;
• used deep brain stimulation (DBS);
• no access to the internet;
• who do not have a caregiver or family member who can assist during the intervention sessions

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator
• Pró-reitoria de Pesquisa da Universidade Federal de Minas Gerais: collaborator

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 31270-901, Brazil

RECRUITING

Related Publications (19)

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MeSH Terms

Conditions

Parkinson Disease; Motor Activity; Hypokinesia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Christina CM Faria, Ph.D.

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina CM Faria, Ph.D.

CONTACT

+55 (31) 34097448; cdcmf@ufmg.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 17, 2024
• Study Start: October 18, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)