Effect of Qigong on Sleep Quality in Fibromyalgia

NCT06347042 | Not Yet Recruiting DMC

• 1 other identifier: 012/004897
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine any significant efficacy of qigong exercise on sleep quality and heart rate variability in patients with fibromyalgia.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (2)

• Sleep quality

  The Pittsburgh Sleep Quality Index (PSQI): It is used to determine self-reported sleep quality and sleep disturbances for the preceding month. It is a consistent and easy for patients and health-care providers in interpreting the indicators of sleep quality. It is a 19-item test and consists of seven components: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) sleep efficiency, (5) sleep disturbance, (6) sleeping medication use and (7) daytime dysfunction. Each component is scored from 0 to 3, and , each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. PSQI (poor sleep: global score \> 5

  evaluated beginning and through study completion, an average of8 weeks

• Heart Rate variability

  Smart watch-derived HRV provides a practical alternative with excellent accuracy compared with ECG-based HRV for global markers and those characterizing lower frequency components. However, caution is warranted with HRV markers that predominantly assess short-term variability.

  evaluated beginning and through study completion, an average of8 weeks short time 5minutes

Secondary Outcomes (4)

• Quality of Life o measure the quality of life of patients with problems found fibromyalgia.

  evaluated beginning and through study completion, an average of8 weeks

• pain self-administered questionnaire

  evaluated beginning and through study completion, an average of8 weeks

• Fatigue :prevalence and severity of fatigue

  evaluated beginning and through study completion, an average of8 weeks

• Depression and Anxiety assess Depression and Anxiety

  evaluated beginning and through study completion, an average of8 weeks

Study Arms (2)

study group

EXPERIMENTAL

receive qigong exercise + routine medical treatment +Anti-inflammatory diet

Other: qigong exercise + routine medical treatment +Anti-inflammatory diet; Other: routine medical treatment +Anti-inflammatory diet only

control group

PLACEBO COMPARATOR

receive medical treatment + Anti-inflammatory diet

Other: routine medical treatment +Anti-inflammatory diet only

Interventions

qigong exercise + routine medical treatment +Anti-inflammatory diet OTHER

1\. Qigong exercise is from traditional Chinese medicine exercise . Qigong is system coordinating slow-flowing movement, deep rhythmic breathing, and a calm meditative state of min Frequency of exercise 3 days a week and 60 min a day, including a 15 min warm up, 40 min and 5min cool down.

study group

routine medical treatment +Anti-inflammatory diet only OTHER

1. Anti-inflammatory diet is characterized by the exclusion of potential inflammatory foods, such as gluten, dairy, free sugar, and ultra-processed food, rich in sugar, hydrogenated fat, and food additives. are some foods with recognized anti-inflammatory potential 2. routine medical treatment

control group; study group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All patients are female
• Age from 30 to 50 years
• Body mass index (BMI) from 18.5 to 34.9 kg/m2.
• Patients will include if they have been diagnosed with FM by rheumatologists as fulfilling all the ACR criteria (1990, 2011 and 2016)
• All patients are ambulant independently
• Stable medication pattern for at least 2 months.

You may not qualify if:

• Presence of any immune diseases or comorbidities that could explain the main symptomatology of FM
• The presence of brain damage, dementia, or neurological disease.
• The presence of psychiatric disorders or current major depressive episode
• Endocrine disorders
• Fractures in upper limb or lower limb
• Participation in regular exercise training of any type in the previous 3 months.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical therapy Cairo University

Cairo, Giza Governorate, Egypt

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

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

Study Officials

• NESSREEN ALNAHAS

  Department of Physical Therapy for Cardiovascular &Respiratory Disorder and Geriatrics- Faculty of Physical therapy Cairo University

  STUDY DIRECTOR

Central Study Contacts

alaa wageih agwa

CONTACT

0020-1121823315; alaawageih9@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: April 4, 2024
• Study Start: April 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

EG (1)