Clinical trial NCT06393790: Strength Training Protocol in Fibromyalgia Women
Official title: Health Effects of a Strength Training Protocol in Women With Fibromyalgia and Healthy Individuals.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Fatigue
Fatigue; Muscle, Heart
Strength Training
Stress
Keywords: Anxiety
exercise
Strength training
fibromyalgia
healthy individuals
women
neuroinmunoendocrine system
Lead sponsor: Catholic University of Murcia
Sponsor class: OTHER
Collaborators: name: Universidad de Extremadura
First posted: 2024-05-01
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Physical exercise is an effective tool for the prevention of various chronic diseases. Fibromyalgia (FM) is a common chronic pain condition, in which patients may also experience a variety of other symptoms, including sleep disturbances, fatigue, stiffness, frequent episodes of pain and mental health problems, as well as possible gastrointestinal disorders. Furthermore, according to the American College of Rheumatology, such a generalised non-joint pain state occurs for at least three months in duration, predominantly in women over 50 years of age. In turn, chronic fatigue syndrome (CFS) presents as a disease characterised by persistent and debilitating fatigue lasting at least six months.

The origin of FM and CFS is unknown, although alterations in the central nervous system (CNS), as well as abnormalities in muscle physiology and immune/inflammatory response are suggested as the main causes.

In addition, most patients with FM are sedentary and in poor physical condition, exacerbated by pain, fatigue or depression, which can limit their daily activities and affect their quality of life and work opportunities. In this regard, physical exercise is considered the most important non-pharmacological strategy for the treatment of FM; however, many clinically relevant questions remain unanswered regarding the most effective approach to exercise therapy in FM patients.

Therefore, the main objective of this project is to analyse the possible physical and mental benefits of a physical exercise programme in people diagnosed with fibromyalgia and/or chronic fatigue syndrome.


Eligibility criteria: Inclusion Criteria:

* Women previously diagnosed with fibromyalgia and healthy women aged 18-75 years.
* Not be undertaking any physical activity or exercise programme for at least three months prior to the start of the protocol.

Exclusion Criteria:

* Participants in the study may not present any other illness and/or injury at the time of the assessments that would prevent them from carrying out the activity. In the same way, those following pharmacological treatments or any type of cardiorespiratory disease will be excluded from the research.

Primary outcomes:
measure: PRE-TEST Time up and go test (TUG test)
timeFrame: 7 days before protocol starts
measure: PRE-TEST 5 Times Sit to stand test (5TSTS)
timeFrame: 7 days before protocol starts
measure: PRE TEST 10 meters walk test
timeFrame: 7 days before protocol starts
measure: PRE TEST 2 minutes walk
timeFrame: 7 days before protocol starts
measure: PRE TEST Upper body dinamometry
timeFrame: 7 days before protocol starts
measure: PRE TEST Lower body dinamometry
timeFrame: 7 days before protocol starts
measure: PRE TEST Sleep assessment: Karolinska Sleepiness Diary
timeFrame: 7 days before protocol starts
measure: PRE TEST Beck Depression Inventory
timeFrame: 7 days before protocol starts
measure: PRE TEST State-Trait Anxiety Inventory
timeFrame: 7 days before protocol starts
measure: PRE TEST Perceived stress scale
timeFrame: 7 days before protocol starts
measure: PRE TEST Pain and fatigue Inventory
timeFrame: 7 days before protocol starts
measure: PRE TEST Pittsburgh Sleep Quality Questionnaire (PSQI)
timeFrame: 7 days before protocol starts
measure: PRE TEST FIQ (Fibromyalgia Impact Questionnaire)
timeFrame: 7 days before protocol starts
measure: PRE TEST Ergospirometry
timeFrame: 7 days before protocol starts
measure: PRE TEST Heart Rate Variability (HRV)
timeFrame: 7 days before protocol starts
measure: PRE TEST BLOOD EXTRACTION
timeFrame: 7 days before protocol starts
measure: PRE TEST Balance test
timeFrame: 7 days before protocol starts
measure: POST-TEST Time up and go test (TUG test)
timeFrame: 7 days after protocol ends
measure: POST-TEST 5 Times Sit to stand test (5TSTS)
timeFrame: 7 days after protocol ends
measure: POST TEST 10 meters walk test
timeFrame: 7 days after protocol ends
measure: POST TEST 2 minutes walk
timeFrame: 7 days after protocol ends
measure: POST TEST Upper body dinamometry
timeFrame: 7 days after protocol ends
measure: POST TEST Lower body dinamometry
timeFrame: 7 days after protocol ends
measure: POST TEST Sleep assessment: Karolinska Sleepiness Diary
timeFrame: 7 days after protocol ends
measure: POST TEST Beck Depression Inventory
timeFrame: 7 days after protocol ends
measure: POST TEST State-Trait Anxiety Inventory
timeFrame: 7 days after protocol ends
measure: POST TEST Perceived stress scale
timeFrame: 7 days after protocol ends
measure: POST TEST Pain and fatigue Inventory
timeFrame: 7 days after protocol ends
measure: POST TEST Pittsburgh Sleep Quality Questionnaire (PSQI)
timeFrame: 7 days after protocol ends
measure: POST TEST FIQ (Fibromyalgia Impact Questionnaire)
timeFrame: 7 days after protocol ends
measure: POST TEST Ergospirometry
timeFrame: 7 days after protocol ends
measure: POST TEST Heart Rate Variability (HRV)
timeFrame: 7 days after protocol ends
measure: POST TEST BLOOD EXTRACTION
timeFrame: 7 days after protocol ends
measure: POST TEST Balance test
timeFrame: 7 days after protocol ends
Secondary outcomes:
measure: ACUTE PRE-TEST Time up and go test (TUG test)
timeFrame: 5 week since the start of the protocol
measure: ACUTE POST-TEST Time up and go test (TUG test)
timeFrame: 5 week since the start of the protocol
measure: ACUTE PRE-TEST 5 Times Sit to stand test (5TSTS)
timeFrame: 5 week since the start of the protocol
measure: ACUTE POST-TEST 5 Times Sit to stand test (5TSTS)
timeFrame: 5 week since the start of the protocol
measure: ACUTE PRE TEST 10 meters walk test
timeFrame: 5 week since the start of the protocol
measure: ACUTE POST TEST 10 meters walk test
timeFrame: 5 week since the start of the protocol
measure: ACUTE PRE TEST Upper body dinamometry
timeFrame: 5 week since the start of the protocol
measure: ACUTE POST TEST Upper body dinamometry
timeFrame: 5 week since the start of the protocol
measure: ACUTE PRE TEST Lower body dinamometry
timeFrame: 5 week since the start of the protocol
measure: ACUTE POST TEST Lower body dinamometry
timeFrame: 5 week since the start of the protocol
measure: ACUTE PRE TEST Sleep assessment: Karolinska Sleepiness Diary
timeFrame: 5 week since the start of the protocol
measure: ACUTE POST TEST Sleep assessment: Karolinska Sleepiness Diary
timeFrame: 5 week since the start of the protocol
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Facultad Deporte Universidad Católica San Antonio de Murcia
state: España
Study officials:
References: