Effects of Complementary Therapies in People With Mild to Moderate Parkinson's Disease

NCT05377073 | Completed

• 1 other identifier: Esain I. Parkinson
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to compare the effects of Hatha Yoga versus Stretching on physical outcomes, quality of life, physical activity and motor examination in persons with Parkinson Disease. The hypothesis of this study is that Hatha Yoga will improve more than Stretching on physical outcomes, quality of life, physical activity and on motor examinations in persons with parkinson Diseases

Conditions

Parkinson Disease

Keywords

Yoga; Stretching; Parkinson disease

Outcome Measures

Primary Outcomes (11)

• Change from baseline in height

  Height is going to be assessed by portable stadiometer (Aisemed T226) to determine change from baseline.

  8 weeks

• Change from baseline in weight

  Weight is going to be assessed by digital scale (Seca Model 868) to determine change from baseline.

  8 weeks

• Change from baseline in Postural control

  Postural control, static balance is assessed with an stabilometric platform to determine change from baseline.

  8 weeks

• Change from baseline in Back Scratch Test

  Flexibility of the upper limb is going to be assessed by the test of the Senior Fitness Test Back Scratch Test, to determine change from baseline.

  8 weeks

• Change from baseline in Chair Sit and Reach Test

  Flexibility of the lower limb is going to be assessed by the test of the Senior Fitness Test Chair Sit and Reach Test, to determine change from baseline.

  8 weeks

• Change from baseline in Time Up and Go test (TUG)

  Dynamic balance and agility is going to be assessed by Time Up and Go test to determine change from baseline.

  8 week

• Change from baseline 5 Times Sit to Stand Test

  Lower limb strength is going to be assessed by 5 Times Sit to Stand Test to determine change from baseline.

  8 weeks

• Change from baseline in Walking speed

  Walking speed is going to be assessed by walking 12 m, and photocells will be placed at 1 m and 11 m, recording time of 10 m to determine change from baseline.

  8 weeks

• Change from baseline in motor examination

  Motor examination is going to be assessed by Unified Parkinson´s Diseases Rating Scale III to determine change form baseline. A higher score means a worse motor state. Total score subscale is 68.

  8 weeks

• Change from baseline in Physical Activity

  Physical activity is going to be assessed by International Physical Activity Questionnaires to determine change from baseline. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (Metabolic equivalent of task minutes a week). Metabolic equivalent of task minutes represent the amount of energy expended carrying out physical activity.

  8 weeks

• Change from baseline in quality of life score

  Quality of life score is going to be assess by Parkinson´s Disease Questionnaires- 39 to determine change from baseline. It has eight dimensions that are coded on a scale of 0 (perfect health as assessed by the measure) to 100 (worse health as assessed by the measure).

  8 weeks

Study Arms (2)

Hatha Yoga

EXPERIMENTAL

Participants performed 1 hour supervised Yoga sessions once a week for a total of eight weeks.

Other: Hatha Yoga

Stretching

EXPERIMENTAL

Participants performed 1 hour supervised Stretching sessions once a week for a total of eight weeks.

Other: Stretching

Interventions

Hatha Yoga OTHER

Patients in the yoga group performed warm-up exercises for 10 minutes, standing, sitting and supine positions of Hatha yoga (30 minutes), and relaxation and breathing exercises (20 minutes). The program consisted of one weekly session for a total of eight weeks.

Hatha Yoga

Stretching OTHER

Patients in the stretching group performed warm-up activities (10 minutes), and analytic stretching exercises targeting the following muscles: sternocleidomastoid, splenius, trapeze, triceps, posterior shoulder capsule, paravertebralis, hamstrings, quadriceps, gastrocnemius, soleus and tibialis anterior (40 minutes). Two repetitions of 15 seconds of each stretch were performed, with a 15 seconds interval between repetitions. The sessions ended with diaphragmatic breathing exercises (10 minutes). The program consisted of one weekly session for a total of eight weeks.

Stretching

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical diagnosis of Parkinson's disease
• Stages I to III on the Hoehn and Yahr scale
• Ability to stand upright unaided and walk with or without technical support

You may not qualify if:

• Participate in another directed physical exercise program during the Project.
• Moderate or severe cognitive decline.

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead

Study Sites (1)

University of the basque Country

Leioa, Bizkaia, 48903, Spain

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Participants were randomly assigned (in a 1:1 ratio) through sealed opaque envelopes to either to the yoga group or the stretching group by coin tossing sequence generation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, Lecturer

Model Details: Parallel randomized controlled trial

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 17, 2022
• Study Start: September 14, 2021
• Primary Completion: October 22, 2021
• Study Completion: January 14, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

ES (1)