The Effect of Group Exercise and Thetahealing on Pain and Quality of Life in Patients With Fibromyalgia

NCT04915742 | Completed DMC

• 1 other identifier: 2021/1366
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Summary Purpose: Determining the Effect of Therapeutic Exercise and Thetahealing on Pain and Quality of Life in Patients with Fibromyalgia Methods: Between February and April 2021, the study started with 58 people who wanted to participate in the study from online platforms and the study was completed with 34 people. Findings: According to the power analysis, at least 34 people will participate in the study. Participants will be divided into 2 groups as experimental and control, thetahealing and exercise will be applied to the experimental group and only exercise sessions will be applied to the control group. The study will be 2 sessions of online group exercises per week for 6 weeks and 1 session of tehetahealing will be applied to the experimental group for 6 weeks. The evaluation will be carried out in the first week before the sessions start and in the last week after the sessions are completed in the form of an online survey.Summary Purpose: Determining the Effect of Therapeutic Exercise and Thetahealing on Pain and Quality of Life in Patients with Fibromyalgia Methods: Between February and April 2021, the study started with 58 people who wanted to participate in the study from online platforms and the study was completed with 34 people. Findings: According to the power analysis, at least 34 people will participate in the study. Participants will be divided into 2 groups as experimental and control, thetahealing and exercise will be applied to the experimental group and only exercise sessions will be applied to the control group. The study will be 2 sessions of online group exercises per week for 6 weeks and 1 session of tehetahealing will be applied to the experimental group for 6 weeks. The evaluation will be carried out in the first week before the sessions start and in the last week after the sessions are completed in the form of an online survey.

Conditions

Fibromyalgia

Keywords

fibromiyalgia; thetahealing; exercises

Outcome Measures

Primary Outcomes (3)

• Short Form-36

  The Short Form-36 is a 36-item short-form questionnaire measuring eight health-related quality-of-life domains: physical functioning (PF), social functioning (SF), role limitation due to physical problems (RP), emotional problems (RE), mental health (MH), energy and vitality (VT), bodily pain (BP), and general health perception (GH). The SF-36 also includes an item for assessing changes in participant's health status over the past year. It is a scale between 0 (worst) and 100 (best) using the standard SF-36 scoring algorithms, with item scores coded, aggregated for each quality of life domain tested.

  6 weeks

• Fibromyalgia Impact Questionnaire

  The Fibromyalgia Impact Questionnaire (FEA) measures 10 different characteristics: physical function, well-being, absenteeism, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. With the exception of the well-being trait, low scores indicate recovery or less affliction. FEA is filled by the patient. The maximum possible score of each sub-title is 10. Thus, the total maximum score is 100. The average FM patient scores 50, while more severely affected FM patients usually score above 70.

  6 weeks

• Numerical Pain Scale

  Numerical Analog Scale (NAS) A scale with values from 0 to 10. Pain in the last 24 hours is evaluated with NAS. If 0 on the scale, I have no pain and 10 means unbearable pain and it is reported that the severity of the pain increases from 0 to 10.

  6 weeks

Study Arms (2)

exercises and thetahealing

EXPERIMENTAL

Behavioral: thetahealing and exercises

exercises

ACTIVE COMPARATOR

Behavioral: exercises

Interventions

exercises BEHAVIORAL

The exercise group ha in FTAs 2, each session will be 30 minutes of evil sown in stretching , which made combining relaxation and strengthening exercises therapeutic exercise program for 6 weeks from the online platform will be implemented in the form of group exercise form is planned.

exercises

thetahealing and exercises BEHAVIORAL

The exercise group ha in FTAs 2, each session will be 30 minutes of evil sown in stretching , which made combining relaxation and strengthening exercises therapeutic exercise program for 6 weeks from the online platform will be implemented in the form of group exercise form is planned. The exercise and Thetahealing treatment group, on the other hand, is planned for 6 weeks , 1 session per week, 30 minutes per session, in addition to the exercise sessions, the first and last sessions to be individual and personalized . Applications will be carried out on the online platform.

exercises and thetahealing

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Using psychotropic medication in the last month
• Known central or peripheral nervous system disease, progressive neurological damage,
• Any serious cardiovascular pathology.
• Any musculoskeletal disease other than fibromyalgia,
• Presence of uncontrolled hypertension,
• Volunteer's request to leave
• Failure to continue training sessions

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu Unıversity

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physioterapist

Model Details: randomize

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 7, 2021
• Study Start: February 1, 2021
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)