Chronic Idiopathic FatigueNCT06203535
Effect of Aerobic Training on Quality of Life in Elderly With Idiopathic Chronic Fatigue
A study testing Aerobic training in people with Chronic Idiopathic Fatigue, run by Pharos University in Alexandria.
Trial summary
the study was conducted to evaluate the effectiveness of aerobic training for decreasing fatigue severity and increasing quality of life in elderly with idiopathic chronic Read more about this study
- Who is it for?
- Ages 60 to 70 years
- Conditions the study is for
- Chronic Idiopathic Fatigue
- What is being tested?
- Aerobic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2024to 7 May 2024
- 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 60 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ages ranged from 60 to 70 years and they will have BMI in between25.0-29.9 kg/m2,
- complaining fatigue least six months ago without identifying any specific cause for their fatigue.
- could walk safely without the aid of another person.
Who cannot join
- Renal, vascular, hepatic, autoimmune, heart, chest and thyroid disorders.
- Lower limb arthritis or any orthopedic problem will hinder the training.
- Cognitive impairment or psychological problems,
- fatigue caused as a known side effect of medication.
- any febrile condition and/or infectious diseases
Trial locations and contacts
No sites are listed yet.
About this study
the study was conducted to evaluate the effectiveness of aerobic training for decreasing fatigue severity and increasing quality of life in elderly with idiopathic chronic
Read the detailed description
idiopathic chronic fatigue (ICF) or chronic idiopathic fatigue (CIF), this type of tiredness is ongoing and unrelated to any underlying medical or mental health issues. Different diagnostic criteria apply to people with idiopathic chronic fatigue and those with chronic fatigue syndrome (CFS).
Regular aerobic exercise has been demonstrated to improve cardiopulmonary fitness, increase physical activity levels, and decrease the degree of fatigue in elderly patients with severe idiopathic fatigue.
- Conditions
- Chronic Idiopathic Fatigue
- Being tested
- Aerobic training
- Keywords
- aerobic training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic trainingOther
Also called traditional physical therapy exersise program
In addition to the standard physical therapy exercise programme (which includes flexibility and balance exercises), twenty individuals with idiopathic chronic fatigue will participate in an aerobic training group and walk for 45 minutes on a treadmill three times a week for two months. The workouts began with a five- to ten-minute warm-up on the treadmill and concluded with an equally extended cool-down. Using the Karvonen method, for exercise intensities range from 60 to 75 percent of heart rate reserve during a 35-minute group cumulative exercise session.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic training (group a) | Experimental | In addition to the standard physical therapy exercise programme (which includes flexibility and balance exercises), twenty individuals with idiopathic chronic fatigue will participate in an aerobic training group and walk for 45 minutes on a treadmill three times a week for two months. The workouts began with a five- to ten-minute warm-up on the treadmill and concluded with an equally extended cool-down. Using the Karvonen method, for exercise intensities ranging from 60 to 75 per cent of heart rate reserve during a 35-minute group cumulative exercise session. Receives: Other: Aerobic training |
| control group (group B) | Experimental | twenty participants have idiopathic chronic fatigue will received only traditional physical therapy exercise program (flexibility and balance activities) Receives: Other: Aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Older People's Quality of Life Questionnaire (OPQOL-brief):
Thirteen items make up the questionnaire; one item includes codes of Strongly agree (1), Agree (2), Neither (3), Disagree (4), and Strongly disagree (5). Positive items are reverse coded to indicate higher quality of life (QoL) with higher scores once all of the questions have been added up to give an overall OPQOL-Brief score.
Measured: 2 monthes will take pre and post total study peroid
fatigue severity assessment scale
Before and during the study period, the physical and mental weariness of both groups (A and B) was measured using a straightforward ten-item fatigue scale. The participants rated an etch statement from five categories, from never to always, using a scale. 1 denotes never, 2 occasionally, 3 regularly, 4 often and 5 always worn out. The greater figure denotes an extremely high degree of exhaustion and fatigue.
Measured: 2 month will take pre and post total study peroid
six mints walk test
Before and during the study period, the aerobic capacity and endurance of both groups (A and B) were assessed using this sub-maximal test. The outcomes were compared to see how the performance capacity changed with walks lasting longer than six minutes.
Measured: 2 monthes will take pre and post total study peroid
Glutathione blood test:
Glutathione is an antioxidant, a type of chemical which helps to boost the immune system as well as prevent and reverse cellular damage. Glutathione levels tend to decrease naturally with age as well as due to health conditions such as liver disease, insomnia, and chronic disease.Before and after the study period, venous blood was taken from both groups (A and B) at baseline when they were not fasting. Tandem mass spectroscopy was used to analyse the samples and determine the degree of serum changes in both study groups based on their respective treatment.
Measured: 2 monthes will take pre and post total study peroid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start10 Feb 2024 (estimated)
- Primary completion13 Apr 2024 (estimated)
- Study completion7 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Idiopathic FatigueStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharos University in Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Mohamed Elsayed Elgohary, Pharos University in Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203535
- Sponsor's protocol ID
- aerobic training and fatigue
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen FT, Etnier JL, Chan KH, Chiu PK, Hung TM, Chang YK. Effects of Exercise Training Interventions on Executive Function in Older Adults: A Systematic Review and Meta-Analysis. Sports Med. 2020 Aug;50(8):1451-1467. doi: 10.1007/s40279-020-01292-x.
PubMed 32447717Hendriks C, Drent M, Elfferich M, De Vries J. The Fatigue Assessment Scale: quality and availability in sarcoidosis and other diseases. Curr Opin Pulm Med. 2018 Sep;24(5):495-503. doi: 10.1097/MCP.0000000000000496.
PubMed 29889115Bowling A, Hankins M, Windle G, Bilotta C, Grant R. A short measure of quality of life in older age: the performance of the brief Older People's Quality of Life questionnaire (OPQOL-brief). Arch Gerontol Geriatr. 2013 Jan-Feb;56(1):181-7. doi: 10.1016/j.archger.2012.08.012. Epub 2012 Sep 19.
PubMed 22999305
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Training on Quality of Life in Elderly With Idiopathic Chronic Fatigue
- ClinicalTrials.gov ID
- NCT06203535
- Acronym / sponsor ID
- aerobic training and fatigue
- Conditions
- Chronic Idiopathic Fatigue
- Keywords
- aerobic training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pharos University in AlexandriaUniversity, hospital or other
- Study start
- 10 Feb 2024 (estimated)
- Primary completion
- 13 Apr 2024 (estimated)
- Study completion
- 7 May 2024 (estimated)
- First posted
- 12 Jan 2024 (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.
the study was conducted to evaluate the effectiveness of aerobic training for decreasing fatigue severity and increasing quality of life in elderly with idiopathic chronic
Detailed description
idiopathic chronic fatigue (ICF) or chronic idiopathic fatigue (CIF), this type of tiredness is ongoing and unrelated to any underlying medical or mental health issues. Different diagnostic criteria apply to people with idiopathic chronic fatigue and those with chronic fatigue syndrome (CFS).
Regular aerobic exercise has been demonstrated to improve cardiopulmonary fitness, increase physical activity levels, and decrease the degree of fatigue in elderly patients with severe idiopathic fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic training (group a) | Experimental | Other: Aerobic trainingIn addition to the standard physical therapy exercise programme (which includes flexibility and balance exercises), twenty individuals with idiopathic chronic fatigue will participate in an aerobic training group and walk for 45 minutes on a treadmill three times a week for two months. The workouts began with a five- to ten-minute warm-up on the treadmill and concluded with an equally extended cool-down. Using the Karvonen method, for exercise intensities ranging from 60 to 75 per cent of heart rate reserve during a 35-minute group cumulative exercise session. |
| control group (group B) | Experimental | Other: Aerobic trainingtwenty participants have idiopathic chronic fatigue will received only traditional physical therapy exercise program (flexibility and balance activities) |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ages ranged from 60 to 70 years and they will have BMI in between25.0-29.9 kg/m2,
- complaining fatigue least six months ago without identifying any specific cause for their fatigue.
- could walk safely without the aid of another person.
Key exclusion criteria (5 listed)
- Renal, vascular, hepatic, autoimmune, heart, chest and thyroid disorders.
- Lower limb arthritis or any orthopedic problem will hinder the training.
- Cognitive impairment or psychological problems,
- fatigue caused as a known side effect of medication.
- any febrile condition and/or infectious diseases
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 |
|---|---|---|
| Aerobic trainingAlso: traditional physical therapy exersise programIn addition to the standard physical therapy exercise programme (which includes flexibility and balance exercises), twenty individuals with idiopathic chronic fatigue will participate in an aerobic training group and walk for 45 minutes on a treadmill three times a week for two months. The workouts began with a five- to ten-minute warm-up on the treadmill and concluded with an equally extended cool-down. Using the Karvonen method, for exercise intensities range from 60 to 75 percent of heart rate reserve during a 35-minute group cumulative exercise session. | Other | Aerobic training (group a), control group (group B) |
Primary outcome
Older People's Quality of Life Questionnaire (OPQOL-brief):
Time frame: 2 monthes will take pre and post total study peroid
Thirteen items make up the questionnaire; one item includes codes of Strongly agree (1), Agree (2), Neither (3), Disagree (4), and Strongly disagree (5). Positive items are reverse coded to indicate higher quality of life (QoL) with higher scores once all of the questions have been added up to give an overall OPQOL-Brief score.
fatigue severity assessment scale
Time frame: 2 month will take pre and post total study peroid
Before and during the study period, the physical and mental weariness of both groups (A and B) was measured using a straightforward ten-item fatigue scale. The participants rated an etch statement from five categories, from never to always, using a scale. 1 denotes never, 2 occasionally, 3 regularly, 4 often and 5 always worn out. The greater figure denotes an extremely high degree of exhaustion and fatigue.
six mints walk test
Time frame: 2 monthes will take pre and post total study peroid
Before and during the study period, the aerobic capacity and endurance of both groups (A and B) were assessed using this sub-maximal test. The outcomes were compared to see how the performance capacity changed with walks lasting longer than six minutes.
Glutathione blood test:
Time frame: 2 monthes will take pre and post total study peroid
Glutathione is an antioxidant, a type of chemical which helps to boost the immune system as well as prevent and reverse cellular damage. Glutathione levels tend to decrease naturally with age as well as due to health conditions such as liver disease, insomnia, and chronic disease.Before and after the study period, venous blood was taken from both groups (A and B) at baseline when they were not fasting. Tandem mass spectroscopy was used to analyse the samples and determine the degree of serum changes in both study groups based on their respective treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Background: PubMed 32447717Chen FT, Etnier JL, Chan KH, Chiu PK, Hung TM, Chang YK. Effects of Exercise Training Interventions on Executive Function in Older Adults: A Systematic Review and Meta-Analysis. Sports Med. 2020 Aug;50(8):1451-1467. doi: 10.1007/s40279-020-01292-x.
- Background: PubMed 29889115Hendriks C, Drent M, Elfferich M, De Vries J. The Fatigue Assessment Scale: quality and availability in sarcoidosis and other diseases. Curr Opin Pulm Med. 2018 Sep;24(5):495-503. doi: 10.1097/MCP.0000000000000496.
- Background: PubMed 22999305Bowling A, Hankins M, Windle G, Bilotta C, Grant R. A short measure of quality of life in older age: the performance of the brief Older People's Quality of Life questionnaire (OPQOL-brief). Arch Gerontol Geriatr. 2013 Jan-Feb;56(1):181-7. doi: 10.1016/j.archger.2012.08.012. Epub 2012 Sep 19.
- Individual participant dataSharing planned: No
Related trials for Chronic Idiopathic Fatigue
Recruiting
Efficacy of Baduanjin Exercise in COVID-19 Contraction Patients With Idiopathic Chronic Fatigue
Chronic COVID-19 Syndrome
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.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training in people with Chronic Idiopathic Fatigue, run by Pharos University in Alexandria.
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 5 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: status not confirmed, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ola elgohary, lecturer (+201227191398, ola.elgohary@pua.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Older People's Quality of Life Questionnaire (OPQOL-brief): (time frame: 2 monthes will take pre and post total study peroid). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06203535, which also lists 3 linked publications.
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 13 Feb 2024.