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

Sponsor
University of the Basque Country (UPV/EHU) (Other)
Overall Status
Completed
CT.gov ID
NCT05377073
Collaborator
(none)
24
1
2
4
6

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Hatha Yoga
  • Other: Stretching
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel randomized controlled trialParallel randomized controlled trial
Masking:
Single (Investigator)
Masking Description:
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.
Primary Purpose:
Prevention
Official Title:
Effects of Hatha Yoga vs Stretching in People With Mild to Moderate Parkinson's Disease
Actual Study Start Date :
Sep 14, 2021
Actual Primary Completion Date :
Oct 22, 2021
Actual Study Completion Date :
Jan 14, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hatha Yoga

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

Other: Hatha Yoga
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.

Experimental: Stretching

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

Other: Stretching
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.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in height [8 weeks]

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

  2. Change from baseline in weight [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 [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 [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 [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) [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 [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 [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 [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 [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of the basque Country Leioa Bizkaia Spain 48903

Sponsors and Collaborators

  • University of the Basque Country (UPV/EHU)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Izaro Esain, Dr, Lecturer, University of the Basque Country (UPV/EHU)
ClinicalTrials.gov Identifier:
NCT05377073
Other Study ID Numbers:
  • Esain I. Parkinson
First Posted:
May 17, 2022
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Izaro Esain, Dr, Lecturer, University of the Basque Country (UPV/EHU)
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2022