NCT06203535

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
29 days until next milestone

Study Start

First participant enrolled

February 10, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2024

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2024

Completed
Last Updated

February 13, 2024

Status Verified

December 1, 2023

Enrollment Period

2 months

First QC Date

December 11, 2023

Last Update Submit

February 9, 2024

Conditions

Keywords

aerobic training

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    2 monthes will take pre and post total study peroid

Study Arms (2)

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.

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)

Other: Aerobic training

Interventions

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.

Also known as: traditional physical therapy exersise program
Aerobic training (group a)control group (group B)

Eligibility Criteria

Age60 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 32447717BACKGROUND
  • 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.

    PMID: 29889115BACKGROUND
  • 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.

    PMID: 22999305BACKGROUND

Central Study Contacts

ola elgohary, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy pharos university

Study Record Dates

First Submitted

December 11, 2023

First Posted

January 12, 2024

Study Start

February 10, 2024

Primary Completion

April 13, 2024

Study Completion

May 7, 2024

Last Updated

February 13, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share