- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06203535
Effect of Aerobic Training on Quality of Life in Elderly With Idiopathic Chronic Fatigue
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ola elgohary, lecturer
- Phone Number: +201227191398
- Email: ola.elgohary@pua.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
inclusion criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: control group (group B)
twenty participants have idiopathic chronic fatigue will received only traditional physical therapy exercise program (flexibility and balance activities)
|
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.
Other Names:
|
|
Experimental: Aerobic training (group a)
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 monthes will take pre and post total study peroid
|
|
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.
|
2 month will take pre and post total study peroid
|
|
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.
|
2 monthes will take pre and post total study peroid
|
|
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.
|
2 monthes will take pre and post total study peroid
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 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.
|
2 monthes will take pre and post total study peroid
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Bowling 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.
- 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.
- Hendriks 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- aerobic training and fatigue
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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