Strength Training Protocol in Fibromyalgia Women

NCT06393790 | Completed

• 1 other identifier: TC/03-23
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Fatigue; Fatigue; Muscle, Heart; Strength Training; Stress

Keywords

Anxiety; exercise; Strength training; fibromyalgia; healthy individuals; women; neuroinmunoendocrine system

Outcome Measures

Primary Outcomes (34)

• PRE-TEST Time up and go test (TUG test)

  The test volunteers will be seated upright in a chair that could be adjusted to suit their leg length, with their legs bent at a 90-degree angle and their arms folded across their chests. Participants were to get up from their seats, move three meters forward, turn around, walk back to the starting point, and then sit down again. Using video capturing, the fastest time between the two trials was found and utilized for analysis

  7 days before protocol starts

• PRE-TEST 5 Times Sit to stand test (5TSTS)

  The 5-times sit-to-stand test assesses the lower limb strength, transitional movements, balance and physical performance of older people. Test subjects were positioned upright in a chair that could be adjusted according to the length of their lower limbs, with their arms crossed over their chests and their legs bent to a 90-degree angle. Participants had to perform a total of five full squats in which the total execution time will be recorded.

  7 days before protocol starts

• PRE TEST 10 meters walk test

  Participants will be instructed to walk 10 m (marked by taped lines) as quickly as possible without running. The test will be repeated after 2 minutes of rest. Verbal encouragement will be given throughout the test. Two photocells (Witty, Microgate, Italy) will be placed at 6 and 10 m to record the walking time. The shortest running time will be used for analysis

  7 days before protocol starts

• PRE TEST 2 minutes walk

  Participants will walk for 2 minutes at the maximum speed they can sustain during that time. The test takes place on a rectangular track (40 x 20 m) with the corners defined by cones. Subjects will be allowed to rest if they need to, but time will not be stopped during their rest period. The total distance (m) covered after 6 min of walking will be measured. All participants will be accompanied by the investigator during the test, but will not be allowed to engage in conversation.

  7 days before protocol starts

• PRE TEST Upper body dinamometry

  The dynamometer TKK 5105 (Takei Scientific Instruments Co., Ltd., Niigata, Japan) will be a typical analog handgrip dynamometer with an adjustable handle. This dynamometer will be used to assess the strength of the handgrip. The participant will be placed in a standing position, with the arms parallel but not touching the body, the shoulder adducted and neutrally rotated, and handgrip strength will be measured. The gadget handle will be modified to fit the size of the participants' hands so that each hand's index finger will be 90 degrees bent from the proximal to middle phalangeal joint. Every side will undergo two trials, alternately, with at least a minute of rest in between each session.

  7 days before protocol starts

• PRE TEST Lower body dinamometry

  Participants will be seated on the isokinetic dynamometer chair (Biodex Medical System, NY) with both legs flexed at 90° and the testing leg's ankle will be strapped directly to a customized apparatus with a load cell (Model SML500, Interface Scottsdale, AZ, USA). To warm up, each subject will perform 3 progressive MVICs with 3 min of rest between attempts. To assess RFD in each leg, verbal encouragement will be given to the participants to apply "as much force as possible, as fast as possible" throughout the 2 consecutive maximal contractions. RFD will be analyzed using the time interval 0-200 (RFDlate). Subsequently, participants will perform 2 MVICs, each lasting for 5 s with 3 min of rest between contractions, with verbal encouragement. Maximal torque (MVIC) and time to peak voluntary torque (time-to-MVIC) will be evaluated. The right leg will always be evaluated first, and the trial with the highest value will be used for both RFD and MVIC.

  7 days before protocol starts

• PRE TEST Sleep assessment: Karolinska Sleepiness Diary

  The Karolinska Sleepiness Diary (KSD) will measure subjective sleep quality (Akerstedt et al., 1994). The KSD will be administered upon awakening in the morning following each of the training sessions (low and high intensity) assessing the following factors using a Likert scale: feeling of rest (1= no rest at all; 3= completely rested); sleep quality (1= very poor; 5= very good); sleep comfort (1= very restless; 5= very calm/relax); ease of falling asleep (1= very difficult; 5= very easy); waking up (1= woken up too early; 3= woken up late); ease of waking up (1= very difficult; 5= very easy); and did you get enough sleep (1= no, definitely very poor; 5= Yes, definitely enough). The higher the score, the higher the quality of sleep will be recorded.

  7 days before protocol starts

• PRE TEST Beck Depression Inventory

  Spanish version (Sanz et al., 2003) of the Beck Depression Inventory (BDI) aimed at determining possible signs of depression in the past week. Higher scores indicate higher levels of depression.

  7 days before protocol starts

• PRE TEST State-Trait Anxiety Inventory

  State-Trait Anxiety and Trait Anxiety Inventory (STAI), to analyse the levels of anxiety presented at a specific time and in general. Spanish version of Buela-Casal \& Guillén-Riquelme (2017). Higher scores indicate higher levels of anxiety.

  7 days before protocol starts

• PRE TEST Perceived stress scale

  The Perceived Stress Scale (PSS), to assess the frequency with which participants experience stressful situations and thoughts in the last month. Higher scores indicate higher levels of stress. Remor (2006) was used in its Spanish version.

  7 days before protocol starts

• PRE TEST Pain and fatigue Inventory

  -Brief Pain Inventory (BPI). Used to determine the intensity and interference of pain in daily activities. The higher the pain perception, the higher the score obtained. The Spanish version of Badía et al. (2003) was used. -Brief Fatigue Inventory (BFI). This questionnaire measures the intensity of fatigue in the last 24 hours and its interference with daily activities and work. The higher the perception of fatigue, the higher the score obtained (Valenzuela et al., 2002).

  7 days before protocol starts

• PRE TEST Pittsburgh Sleep Quality Questionnaire (PSQI)

  Pittsburgh Sleep Quality Questionnaire (PSQI). This questionnaire analyses various parameters related to subjective sleep quality: latency, duration, efficiency and disturbances, as well as consumption of sleeping pills. The Spanish version of the PSQI was used, Hita-Contreras et al.

  7 days before protocol starts

• PRE TEST FIQ (Fibromyalgia Impact Questionnaire)

  FIQ (Fibromyalgia Impact Questionnaire). The Spanish version of Rivera \& González (2004) was used to assess the impact of fibromyalgia on physical and mental functions (pain, tiredness, fatigue, stiffness, anxiety and depression). Higher scores indicate a worse health condition.

  7 days before protocol starts

• PRE TEST Ergospirometry

  The incremental protocol will include a 3-minute warm-up (4.5 km-h -1) followed by an increase to 6 km-h -1, with 1 km-h -1 increments every 45 seconds until exhaustion. Heart rate and the different spirometric variables, including respiratory exchange ratio (RER) and V̇O2 will be constantly monitored. The breath-by-breath method will be used to collect ventilation data during the incremental exercise test for individual assessment of maximal oxygen consumption capacity. The volume transducer and the Vyntus TM CPX gas analyser (Vyaire medical, INC, Hoechberg, Germany) shall be calibrated according to the manufacturer's instructions prior to each test.

  7 days before protocol starts

• PRE TEST Heart Rate Variability (HRV)

  HRV analysis. HRV analysis will be performed using a Polar H7 heart rate sensor (Kempele, Finland) to measure R-R intervals during the night at pre- and post-confinement. Analysis of HRV variables will be performed with Kubios HRV 3.0 software (Kuopio, Finland). Additionally, and if necessary, artefact correction will be performed with the same software by applying very low, low or medium threshold filters.

  7 days before protocol starts

• PRE TEST BLOOD EXTRACTION

  To carry out the blood extraction, a qualified person will perform a sterile puncture in the cubitus median vein. After 15 minutes of extraction (in the case of serum, essential to facilitate clot formation), both tubes are centrifuged for 10 minutes at 1,600 rpm and at 22ºC. By this process, serum or plasma is isolated in the corresponding tubes and then aliquoted into eppendorf tubes with a total volume of 400 μl in each tube. The serum and plasma samples must be gradually frozen as they are obtained, until they are finally stored at -80ºC.

  7 days before protocol starts

• PRE TEST Balance test

  Determination of monopodal and bipodal equilibrium levels.

  7 days before protocol starts

• POST-TEST Time up and go test (TUG test)

  The test volunteers will be seated upright in a chair that could be adjusted to suit their leg length, with their legs bent at a 90-degree angle and their arms folded across their chests. Participants were to get up from their seats, move three meters forward, turn around, walk back to the starting point, and then sit down again. Using video capturing, the fastest time between the two trials was found and utilized for analysis

  7 days after protocol ends

• POST-TEST 5 Times Sit to stand test (5TSTS)

  The 5-times sit-to-stand test assesses the lower limb strength, transitional movements, balance and physical performance of older people. Test subjects were positioned upright in a chair that could be adjusted according to the length of their lower limbs, with their arms crossed over their chests and their legs bent to a 90-degree angle. Participants had to perform a total of five full squats in which the total execution time will be recorded.

  7 days after protocol ends

• POST TEST 10 meters walk test

  Participants will be instructed to walk 10 m (marked by taped lines) as quickly as possible without running. The test will be repeated after 2 minutes of rest. Verbal encouragement will be given throughout the test. Two photocells (Witty, Microgate, Italy) will be placed at 6 and 10 m to record the walking time. The shortest running time will be used for analysis

  7 days after protocol ends

• POST TEST 2 minutes walk

  Participants will walk for 2 minutes at the maximum speed they can sustain during that time. The test takes place on a rectangular track (40 x 20 m) with the corners defined by cones. Subjects will be allowed to rest if they need to, but time will not be stopped during their rest period. The total distance (m) covered after 6 min of walking will be measured. All participants will be accompanied by the investigator during the test, but will not be allowed to engage in conversation.

  7 days after protocol ends

• POST TEST Upper body dinamometry

  The dynamometer TKK 5105 (Takei Scientific Instruments Co., Ltd., Niigata, Japan) will be a typical analog handgrip dynamometer with an adjustable handle. This dynamometer will be used to assess the strength of the handgrip. The participant will be placed in a standing position, with the arms parallel but not touching the body, the shoulder adducted and neutrally rotated, and handgrip strength will be measured. The gadget handle will be modified to fit the size of the participants' hands so that each hand's index finger will be 90 degrees bent from the proximal to middle phalangeal joint. Every side will undergo two trials, alternately, with at least a minute of rest in between each session.

  7 days after protocol ends

• POST TEST Lower body dinamometry

  Participants will be seated on the isokinetic dynamometer chair (Biodex Medical System, NY) with both legs flexed at 90° and the testing leg's ankle will be strapped directly to a customized apparatus with a load cell (Model SML500, Interface Scottsdale, AZ, USA). To warm up, each subject will perform 3 progressive MVICs with 3 min of rest between attempts. To assess RFD in each leg, verbal encouragement will be given to the participants to apply "as much force as possible, as fast as possible" throughout the 2 consecutive maximal contractions. RFD will be analyzed using the time interval 0-200 (RFDlate). Subsequently, participants will perform 2 MVICs, each lasting for 5 s with 3 min of rest between contractions, with verbal encouragement. Maximal torque (MVIC) and time to peak voluntary torque (time-to-MVIC) will be evaluated. The right leg will always be evaluated first, and the trial with the highest value will be used for both RFD and MVIC.

  7 days after protocol ends

• POST TEST Sleep assessment: Karolinska Sleepiness Diary

  The Karolinska Sleepiness Diary (KSD) will measure subjective sleep quality (Akerstedt et al., 1994). The KSD will be administered upon awakening in the morning following each of the training sessions (low and high intensity) assessing the following factors using a Likert scale: feeling of rest (1= no rest at all; 3= completely rested); sleep quality (1= very poor; 5= very good); sleep comfort (1= very restless; 5= very calm/relax); ease of falling asleep (1= very difficult; 5= very easy); waking up (1= woken up too early; 3= woken up late); ease of waking up (1= very difficult; 5= very easy); and did you get enough sleep (1= no, definitely very poor; 5= Yes, definitely enough). The higher the score, the higher the quality of sleep will be recorded.

  7 days after protocol ends

• POST TEST Beck Depression Inventory

  Spanish version (Sanz et al., 2003) of the Beck Depression Inventory (BDI) aimed at determining possible signs of depression in the past week. Higher scores indicate higher levels of depression.

  7 days after protocol ends

• POST TEST State-Trait Anxiety Inventory

  State-Trait Anxiety and Trait Anxiety Inventory (STAI), to analyse the levels of anxiety presented at a specific time and in general. Spanish version of Buela-Casal \& Guillén-Riquelme (2017). Higher scores indicate higher levels of anxiety.

  7 days after protocol ends

• POST TEST Perceived stress scale

  The Perceived Stress Scale (PSS), to assess the frequency with which participants experience stressful situations and thoughts in the last month. Higher scores indicate higher levels of stress. Remor (2006) was used in its Spanish version.

  7 days after protocol ends

• POST TEST Pain and fatigue Inventory

  -Brief Pain Inventory (BPI). Used to determine the intensity and interference of pain in daily activities. The higher the pain perception, the higher the score obtained. The Spanish version of Badía et al. (2003) was used. -Brief Fatigue Inventory (BFI). This questionnaire measures the intensity of fatigue in the last 24 hours and its interference with daily activities and work. The higher the perception of fatigue, the higher the score obtained (Valenzuela et al., 2002).

  7 days after protocol ends

• POST TEST Pittsburgh Sleep Quality Questionnaire (PSQI)

  Pittsburgh Sleep Quality Questionnaire (PSQI). This questionnaire analyses various parameters related to subjective sleep quality: latency, duration, efficiency and disturbances, as well as consumption of sleeping pills. The Spanish version of the PSQI was used, Hita-Contreras et al.

  7 days after protocol ends

• POST TEST FIQ (Fibromyalgia Impact Questionnaire)

  FIQ (Fibromyalgia Impact Questionnaire). The Spanish version of Rivera \& González (2004) was used to assess the impact of fibromyalgia on physical and mental functions (pain, tiredness, fatigue, stiffness, anxiety and depression). Higher scores indicate a worse health condition.

  7 days after protocol ends

• POST TEST Ergospirometry

  The incremental protocol will include a 3-minute warm-up (4.5 km-h -1) followed by an increase to 6 km-h -1, with 1 km-h -1 increments every 45 seconds until exhaustion. Heart rate and the different spirometric variables, including respiratory exchange ratio (RER) and V̇O2 will be constantly monitored. The breath-by-breath method will be used to collect ventilation data during the incremental exercise test for individual assessment of maximal oxygen consumption capacity. The volume transducer and the Vyntus TM CPX gas analyser (Vyaire medical, INC, Hoechberg, Germany) shall be calibrated according to the manufacturer's instructions prior to each test.

  7 days after protocol ends

• POST TEST Heart Rate Variability (HRV)

  HRV analysis. HRV analysis will be performed using a Polar H7 heart rate sensor (Kempele, Finland) to measure R-R intervals during the night at pre- and post-confinement. Analysis of HRV variables will be performed with Kubios HRV 3.0 software (Kuopio, Finland). Additionally, and if necessary, artefact correction will be performed with the same software by applying very low, low or medium threshold filters.

  7 days after protocol ends

• POST TEST BLOOD EXTRACTION

  To carry out the blood extraction, a qualified person will perform a sterile puncture in the cubitus median vein. After 15 minutes of extraction (in the case of serum, essential to facilitate clot formation), both tubes are centrifuged for 10 minutes at 1,600 rpm and at 22ºC. By this process, serum or plasma is isolated in the corresponding tubes and then aliquoted into eppendorf tubes with a total volume of 400 μl in each tube. The serum and plasma samples must be gradually frozen as they are obtained, until they are finally stored at -80ºC.

  7 days after protocol ends

• POST TEST Balance test

  Determination of monopodal and bipodal equilibrium levels.

  7 days after protocol ends

Secondary Outcomes (12)

• ACUTE PRE-TEST Time up and go test (TUG test)

  5 week since the start of the protocol

• ACUTE POST-TEST Time up and go test (TUG test)

  5 week since the start of the protocol

• ACUTE PRE-TEST 5 Times Sit to stand test (5TSTS)

  5 week since the start of the protocol

• ACUTE POST-TEST 5 Times Sit to stand test (5TSTS)

  5 week since the start of the protocol

• ACUTE PRE TEST 10 meters walk test

  5 week since the start of the protocol

Study Arms (2)

Strength training group with fibromyalgia diagnosis

EXPERIMENTAL

The sample will be composed of 15 subjects (women), aged between 18 and 70 years. Participants must have been diagnosed with fibromyalgia (FM) and/or chronic fatigue syndrome (CFS) at least three months before the start of the study. Study participants must not have any other illness and/or injury at the time of the assessments that would prevent them from performing the activity. Likewise, those following pharmacological treatments or any type of cardiorespiratory disease will be excluded from the research.

Behavioral: FMG (Fibromyalgia group)

Strength training group in no fibromyalgia women

ACTIVE COMPARATOR

The sample will be composed of 15 subjects (women), aged between 45 and 70 years. Participants must have not been diagnosed with fibromyalgia. These participants must be healthy individuals. Study participants must not have any other illness and/or injury at the time of the assessments that would prevent them from performing the activity. Likewise, those following pharmacological treatments or any type of cardiorespiratory disease will be excluded from the research.

Behavioral: HG (Healthy group)

Interventions

FMG (Fibromyalgia group) BEHAVIORAL

This intervention will report results of a strength training programme in people with fibromyalgia

Strength training group with fibromyalgia diagnosis

HG (Healthy group) BEHAVIORAL

This intervention will report results of a strength training programme in people with no fibromyalgia diagnosis

Strength training group in no fibromyalgia women

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catholic University of Murcia: lead
• Universidad de Extremadura: collaborator

Study Sites (1)

Facultad Deporte Universidad Católica San Antonio de Murcia

Murcia, España, 30107, Spain

Location

MeSH Terms

Conditions

Fibromyalgia; Fatigue; Anxiety Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: May 1, 2024
• Study Start: April 1, 2024
• Primary Completion: July 30, 2024
• Study Completion: January 1, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

ES (1)