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Completed

NCT Number: NCT05377073

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

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

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Key information

Conditions

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

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of the basque Country

Leioa, Bizkaia, 48903, Spain

About this study

Individuals diagnosed with Parkinson 's disease, signed up at the Parkinson's association in Asparbi (Bilbao, Basque Country), and meeting the inclusion criteria were included in the study. These individuals were randomly assigned (in a 1:1 ratio) through sealed opaque envelopes to either to Hatha Yoga group and Stretching group by coin tossing sequence generation

Both programs consisted of one weekly session for a total of eight weeks.

Hatha 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).

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 15 seconds interval between repetitions. The sessions ended with diaphragmatic breathing exercises (10 minutes).

Demographic information form was filled out by patients including information about: age, height (cm), weight (kg). Additionally, the following measures are going to be measured:

  • Postural control is assessed with a stabilometric platform.
  • Flexibility ( Back Scratch Test and Chair Sit and Reach Test)
  • Time Up and Go test (TUG)
  • 5 Times Sit to Stand Test
  • Walking speed
  • Unified Parkinson´s Diseases Rating Scale III (UPDRS-III)
  • International Physical Activity Questionnaires (IPAQ)
  • Parkinson´s Disease Questionnaires- 39 (PDQ-39)

SPSS version 22 program was used in the analysis of the data. Mann Whitney U test, Wilcoxon test, Student T test and two-way mixed Anova were used to analyse the results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change from baseline in height

    Time frame: 8 weeks

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

  2. Change from baseline in weight

    Time frame: 8 weeks

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

  3. Change from baseline in Postural control

    Time frame: 8 weeks

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

  4. Change from baseline in Back Scratch Test

    Time frame: 8 weeks

    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.

  5. Change from baseline in Chair Sit and Reach Test

    Time frame: 8 weeks

    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.

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

    Time frame: 8 week

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

  7. Change from baseline 5 Times Sit to Stand Test

    Time frame: 8 weeks

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

  8. Change from baseline in Walking speed

    Time frame: 8 weeks

    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.

  9. Change from baseline in motor examination

    Time frame: 8 weeks

    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.

  10. Change from baseline in Physical Activity

    Time frame: 8 weeks

    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.

  11. Change from baseline in quality of life score

    Time frame: 8 weeks

    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).

Sponsors and collaborators

Lead sponsor

University of the Basque Country (UPV/EHU)

Other

Registry information

Official study title

Effects of Hatha Yoga vs Stretching in People With Mild to Moderate Parkinson's Disease

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 17, 2022
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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