Physical and Rehabilitation MedicineNCT04699370
The Added Value of Cognition-targeted Exercise Versus Symptom-targeted Exercise for Multiple Sclerosis Fatigue
A study testing cognition-targeted exercise, Cognitive behavioral therapy and Standardized physical therapy in people with Physical and Rehabilitation Medicine, run by Cairo University at 1 site in Egypt.
Trial summary
Introduction: Multiple sclerosis (MS) has a wide range of physiological and neuropsychological symptoms. Over 75% of MS patients complain about fatigue, which for many is one of their most debilitating symptoms, having a substantial impact on their quality of life and ability to carry out day-to-day tasks. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Physical and Rehabilitation Medicine
- What is being tested?
- cognition-targeted exercise, Cognitive behavioral therapy and Standardized physical therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 4 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of multiple sclerosis by a neurologist which incorporate clinical features with magnetic resonance scanning.
- Being within normal or average dysfunction and excluding those scoring ≤6 in the Expanded Disability Status Scale (EDSS);
- Being identified as a case level of fatigue; fatigue score of 4 or greater on the Fatigue Scale (FS);
Who cannot join
- Patients with any serious psychological disorders (including psychotic disorders or active substance abuse), or those with any chronic illness that may be contributing to fatigue were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Added Value of Cognition-targeted Exercise Versus Symptom-targeted Exercise for Multiple Sclerosis Fatigue: Randomized Controlled Trial
Introduction: Multiple sclerosis (MS) has a wide range of physiological and neuropsychological symptoms. Over 75% of MS patients complain about fatigue, which for many is one of their most debilitating symptoms, having a substantial impact on their quality of life and ability to carry out day-to-day tasks. Previous investigations on the effectiveness of different types of psychotherapy on MS fatigue are extremely limited. The aim of this study was to investigate the added value of cognition-targeted exercise versus symptom-targeted exercise for Multiple Sclerosis fatigue
Read the detailed description
Patients with fatigue symptoms (score of ≥5 on Fatigue Scale) will be randomly assigned into experimental (n=30) and control (n=30) groups. The subjects in the experimental group will receive eight 50-minute sessions of weekly cognitive behavior therapy based on van Kessel's model in addition cognition-targeted exercise program , whereas the patients in the control group will receive eight 50-minute sessions of weekly CBT in addition to standardized physiotherapy program . A standardized program of physiotherapy exercises will consist of twice-weekly supervised general aerobic, strengthening and flexibility exercise sessions. This exercise program is reflective of the general exercises typically undertaken within routine clinical practice.
- Conditions
- Physical and Rehabilitation Medicine
- Being tested
- cognition-targeted exercise, Cognitive behavioral therapy, Standardized physical therapy
- Keywords
- Randomized controlled trial, Multiple Sclerosis, Fatigue, Cognitive Behavioral Therapy, exercise
- Medical subject headings
- Multiple Sclerosis, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognition-targeted exerciseOther
All Standardized physical therapy exercises will be performed in a time-contingent .
Goal setting is essentially done together with the patient, focussing on functionality instead of fatigue relief. Progression to a next level of (more difficult) exercises will be preceded by an intermediate phase of motor imagery.
The treating physical therapist will be advised to address patients' cognitions about their problems during the cognition-targeted exercise training, so that patients will have positive perceptions regarding their illness and treatment outcome.
The treating physical therapist will be advised to discuss the patient's perceptions about each exercise. This include discussion of the anticipated consequences of the exercises and challenging the patient's cognitions in relation to the exercises
Cognitive behavioral therapyBehavioural
In the first and second sessions, patients will learn about fatigue-related symptoms as well as Cognitive behavioral therapy and its effectiveness. The third and fourth sessions will be devoted on the introduction of behavioral strategies. The fifth session will introduce cognitive strategies to decrease fatigue. The last three sessions will be about how to adopt the proposed strategies consistently.
Standardized physical therapyOther
The standardized physical therapy will consist of eight half-hour individualized face to face physiotherapy sessions, over a 4-week period. this program will consist of twice-weekly supervised general aerobic, strengthening and flexibility exercise sessions .This exercise program is reflective of the general exercises typically undertaken within routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| cognition-targeted exercise | Experimental | The patients in this group will receive cognitive behavior therapy in addition to cognition-targeted exercise .
Cognitive behavior therapy will be designed on the basis of van Kessel's model . The main objective of this treatment will be challenging all external factors (e.g. behavioral, cognitive, and affective factors) envisioned to play a role in the development and persistence of fatigue in MS patients. The treatment sessions will be directed individually.
For Cognition- targeted exercise , all standardized physical therapy exercises will be performed in a time-contingent rather than in a symptom-contingent way . Receives: Other: cognition-targeted exercise; Behavioral: Cognitive behavioral therapy |
| symptom-targeted exercise | Active comparator | The patients in this group will receive cognitive behavior therapy in addition to symptom-targeted exercise .
Cognitive behavior therapy will be designed on the basis of van Kessel's model . The main objective of this treatment will be challenging all external factors (e.g. behavioral, cognitive, and affective factors) envisioned to play a role in the development and persistence of fatigue in MS patients. The treatment sessions will be directed individually.
For symptom- targeted exercise, All Standardized physical therapy exercises will be performed in a symptom-contingent way ("Stop or adjust the exercise when it hurts"). Receives: Behavioral: Cognitive behavioral therapy; Other: Standardized physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Fatigue Impact Scale
The Modified Fatigue Impact Scale is a modified form of the Fatigue Impact Scale based on items derived from interviews with MS patients concerning how fatigue impacts their lives. Items on the Modified Fatigue Impact Scale are aggregated into three subscales (physical, cognitive, and psychosocial), as well as into a total Modified Fatigue Impact Scale score. All items are scaled so that higher scores indicate a greater impact of fatigue on a person's activities.
Measured: pre-treatment , at 4-week,and after three months
Secondary outcomes (3)
Change in Work and Social Adjustment Scale
The Work and Social Adjustment Scale , which assessed fatigue-related impairment in relation to a number of areas of the person's life. The maximum score is 40 .lower score is better
Measured: pre-treatment , at 4-week,and after three months
Change in Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale , a commonly used self-report instrument for detecting states of depression and anxiety in patients with medical illnesses. scores of less than 7 indicate non-cases and high scores indicate more anxiety and depression
Measured: pre-treatment , at 4-week,and after three months
Change in Perceived Stress Scale
the Perceived Stress Scale will be included to assess whether the degree to which patients appraised situations in their lives as stressful changed after the intervention. Individual scores on the Perceived Stress Scale can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: pre-treatment , at 4-week,and after three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start1 Jan 2021
- Primary completion20 Feb 2021
- Study completion4 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical and Rehabilitation MedicineStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to the control group or intervention group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Moustafa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699370
- Sponsor's protocol ID
- Cairo 2021
- Status last verified
- Jun 2021
- First submitted
- 2 Jan 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to make individual participant data (IPD) available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Added Value of Cognition-targeted Exercise Versus Symptom-targeted Exercise for Multiple Sclerosis Fatigue: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04699370
- Acronym / sponsor ID
- Cairo 2021
- Conditions
- Physical and Rehabilitation Medicine
- Keywords
- Randomized controlled trial, Multiple Sclerosis, Fatigue, Cognitive Behavioral Therapy, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 20 Feb 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Multiple sclerosis (MS) has a wide range of physiological and neuropsychological symptoms. Over 75% of MS patients complain about fatigue, which for many is one of their most debilitating symptoms, having a substantial impact on their quality of life and ability to carry out day-to-day tasks. Previous investigations on the effectiveness of different types of psychotherapy on MS fatigue are extremely limited. The aim of this study was to investigate the added value of cognition-targeted exercise versus symptom-targeted exercise for Multiple Sclerosis fatigue
Detailed description
Patients with fatigue symptoms (score of ≥5 on Fatigue Scale) will be randomly assigned into experimental (n=30) and control (n=30) groups. The subjects in the experimental group will receive eight 50-minute sessions of weekly cognitive behavior therapy based on van Kessel's model in addition cognition-targeted exercise program , whereas the patients in the control group will receive eight 50-minute sessions of weekly CBT in addition to standardized physiotherapy program . A standardized program of physiotherapy exercises will consist of twice-weekly supervised general aerobic, strengthening and flexibility exercise sessions. This exercise program is reflective of the general exercises typically undertaken within routine clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to the control group or intervention group.
| Arm | Type | Receives |
|---|---|---|
| cognition-targeted exercise | Experimental | Other: cognition-targeted exercise, Behavioral: Cognitive behavioral therapyThe patients in this group will receive cognitive behavior therapy in addition to cognition-targeted exercise . Cognitive behavior therapy will be designed on the basis of van Kessel's model . The main objective of this treatment will be challenging all external factors (e.g. behavioral, cognitive, and affective factors) envisioned to play a role in the development and persistence of fatigue in MS patients. The treatment sessions will be directed individually. For Cognition- targeted exercise , all standardized physical therapy exercises will be performed in a time-contingent rather than in a symptom-contingent way . |
| symptom-targeted exercise | Active comparator | Behavioral: Cognitive behavioral therapy, Other: Standardized physical therapyThe patients in this group will receive cognitive behavior therapy in addition to symptom-targeted exercise . Cognitive behavior therapy will be designed on the basis of van Kessel's model . The main objective of this treatment will be challenging all external factors (e.g. behavioral, cognitive, and affective factors) envisioned to play a role in the development and persistence of fatigue in MS patients. The treatment sessions will be directed individually. For symptom- targeted exercise, All Standardized physical therapy exercises will be performed in a symptom-contingent way ("Stop or adjust the exercise when it hurts"). |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of multiple sclerosis by a neurologist which incorporate clinical features with magnetic resonance scanning.
- Being within normal or average dysfunction and excluding those scoring ≤6 in the Expanded Disability Status Scale (EDSS);
- Being identified as a case level of fatigue; fatigue score of 4 or greater on the Fatigue Scale (FS);
Key exclusion criteria (1 listed)
- Patients with any serious psychological disorders (including psychotic disorders or active substance abuse), or those with any chronic illness that may be contributing to fatigue were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognition-targeted exerciseAll Standardized physical therapy exercises will be performed in a time-contingent . Goal setting is essentially done together with the patient, focussing on functionality instead of fatigue relief. Progression to a next level of (more difficult) exercises will be preceded by an intermediate phase of motor imagery. The treating physical therapist will be advised to address patients' cognitions about their problems during the cognition-targeted exercise training, so that patients will have positive perceptions regarding their illness and treatment outcome. The treating physical therapist will be advised to discuss the patient's perceptions about each exercise. This include discussion of the anticipated consequences of the exercises and challenging the patient's cognitions in relation to the exercises | Other | cognition-targeted exercise |
| Cognitive behavioral therapyIn the first and second sessions, patients will learn about fatigue-related symptoms as well as Cognitive behavioral therapy and its effectiveness. The third and fourth sessions will be devoted on the introduction of behavioral strategies. The fifth session will introduce cognitive strategies to decrease fatigue. The last three sessions will be about how to adopt the proposed strategies consistently. | Behavioural | cognition-targeted exercise, symptom-targeted exercise |
| Standardized physical therapyThe standardized physical therapy will consist of eight half-hour individualized face to face physiotherapy sessions, over a 4-week period. this program will consist of twice-weekly supervised general aerobic, strengthening and flexibility exercise sessions .This exercise program is reflective of the general exercises typically undertaken within routine clinical practice. | Other | symptom-targeted exercise |
Primary outcome
Change in Modified Fatigue Impact Scale
Time frame: pre-treatment , at 4-week,and after three months
The Modified Fatigue Impact Scale is a modified form of the Fatigue Impact Scale based on items derived from interviews with MS patients concerning how fatigue impacts their lives. Items on the Modified Fatigue Impact Scale are aggregated into three subscales (physical, cognitive, and psychosocial), as well as into a total Modified Fatigue Impact Scale score. All items are scaled so that higher scores indicate a greater impact of fatigue on a person's activities.
3 secondary outcomes
Change in Work and Social Adjustment Scale
Time frame: pre-treatment , at 4-week,and after three months
Change in Hospital Anxiety and Depression Scale
Time frame: pre-treatment , at 4-week,and after three months
Change in Perceived Stress Scale
Time frame: pre-treatment , at 4-week,and after three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Individual participant dataSharing planned: No. no plan to make individual participant data (IPD) available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognition-targeted exercise, Cognitive behavioral therapy and Standardized physical therapy in people with Physical and Rehabilitation Medicine, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Modified Fatigue Impact Scale (time frame: pre-treatment , at 4-week,and after three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.