Effectiveness of Qigong vs. Physiotherapy to Improve Quality of Life of Women With Fibromyalgia

NCT04328142 | Completed

• 1 other identifier: 11//2012
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study analyze the effectiveness of a Physiotherapy treatment versus a Qigong exercise programme improving quality of life of subjects with Fibromyalgia.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Physiotherapy; Qigong; Quality of life

Outcome Measures

Primary Outcomes (6)

• Change from the Spanish Fibromyalgia Impact Questionnaire (SFIQ) at post intervention (week 6)

  SFIQ measures the level of quality of life of subjects with Fibromyalgia with a score of 0 to 100. A higher score indicates more impact of the condition on the life of the person and therefore less quality of life.

  Baseline (week 0), pre intervention (week 1) and post intervention (week 6).

• Change from Visual Analogue Scale (VAS) at post intervention (week 6)

  The Visual analogue scale measures the level of pain with a score of 0 to 10 where 0 indicates no pain and 10 indicates maximun pain.

  Baseline (week 0), pre intervention (week 1) and post intervention (week 6).

• Change from Borg Scale of perceived exertion at post intervention (week 6)

  Borg scale measures the perceived exertion of a subject with a score of 0 to 10 where 0 is the minimum exertion and 10 is the maximun exertion.

  Baseline (week 0), pre intervention (week 1) and post intervention (week 6).

• Changes from the values registered by the Spirobank-G (MIR)® spirometer

  Spirometry measures respiratory values being the reference values (Knudson model) for a 50 year old woman with 1,65 cm of height and 65 kilos weight: FVC (Forced vital capacity)= 3.611, FEV1 (Forced expiratory volume) = 2.7505, FEV1%= 76.17%, FEF (Forced expiratory flow) 25-75%= 2.625, PEF (peak expiratory flow)= 6.222

  Baseline (week 0), pre intervention (week 1) and post intervention (week 6).

• Change from the centre of gravity registered with Wii-fit Nintendo®

  Static balance and postural control is the ability to maintain the centre of gravity within the base of support. Centre of gravity is measured in percentage through posturography study. A higher percentage means better balance

  Baseline (week 0), pre intervention (week 1) and post intervention (week 6).

• Change from the monopodal stance test registered with Wii-fit Nintendo®

  Monopodal stance test measures static balance in percentage through posturography study. It is measure in percentage from 0 to 100 and a higher percentage means a better result.

  Baseline (week 0), pre intervention (week 1) and post intervention (week 6).

Secondary Outcomes (3)

• Change from range of movement measured with goniometer

  Baseline (week 0), pre intervention (week 1) and post intervention (week 6).

• Change from muscle strength measured with Lovett scale

  Baseline (week 0), pre intervention (week 1) and post intervention (week 6).

• Change from flexibility measured with the Wells y Dillon scale

  Baseline (week 0), pre intervention (week 1) and post intervention (week 6).

Study Arms (3)

Qigong

EXPERIMENTAL

The Qigong experimental group performed the 20 figures to improve health and longevity described by the master of Qigong 'Wang Ziping'. These are based on therapeutic exercises of Traditional Chinese Medicine. They work on breathing, flexibility and balance. Each figure was repeated 6 times. The sessions were administered twice a week during 45 minutes and were guided by a Doctor in Western Medicine who is also qualified as a Doctor of Traditional Chinese Medicine and Qigong teacher.

Other: Qigong group

Physiotherapy

EXPERIMENTAL

The physiotherapy experimental group completed an active exercises program guided by a qualified physiotherapist. The exercise programme was based on active shoulder, hips and spine kinesiotherapy. It included a warm up of 3-5 minutes walking, followed by 6 repetitions of shoulder and hip exercises in standing, cervical spine exercises in sitting or standing, according to the comfort of the patient, thoracic and lumbar spine exercises performed in supine on a mat and balance exercises in standing. Stretching exercises were also performed at the end of the session. The exercises were accompanied by gentle breathing coordinated with the movements. The sessions were administered twice a week during 45 minutes.

Other: Physiotherapy

Control

NO INTERVENTION

The control group did not receive any intervention. The participants continued with their routine medical treatment.

Interventions

Qigong group OTHER

Traditional Chinese Medicine exercise programme

Qigong

Physiotherapy OTHER

Physiotherapy exercise programme

Physiotherapy

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women between 30 and 65 years old,
• diagnosed with Fibromyalgia by a specialized physician,

Sponsors & Collaborators

• University of Extremadura: lead

MeSH Terms

Conditions

Fibromyalgia

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Neither the participants nor their therapists were blind to the treatment allocation. However, the assessor was independent to the study and was not aware of the treatments applied or the objective of the therapy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHYSIOTHERAPIST

Model Details: Participants were randomized to a Qigong exercise programme group, a Physiotherapy treatment group and control group for a 6 week study.

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: March 31, 2020
• Study Start: March 1, 2012
• Primary Completion: September 30, 2013
• Study Completion: September 30, 2013
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share