To determine the individual effects of aerobic training and circuit training and comparison of these two on balance and disease severity in ataxic patients.
The setting of this study is Allied Hospital, Faisalabad. It is a single blinded study in which participants will be blinded. They will be allocated into the groups through online randomization generator.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
• Participants ranging from 30-65 years of age were included in this study (mid adulthood).
• Scale for Assessment and Rating of Ataxia (SARA) sitting sub-score was less than or equal to 1 (patients are able to sit and use a stationary exercise bike).
• Both genders were included in this study.
• Hemodynamically stable patients.
• Patient fall on stage “3 and 4” of Ataxia staging scale.
• Patients were able to walk independently with or without assistive device for at least 5 minutes (as a minimum criteria).
Exclusion Criteria
• Patient suffering from recent surgery of low back or lower limb.
• Patient encountered any recent musculoskeletal injury (fracture, dislocation, soft tissue injury).
• Patients suffering from heart problems/diseases.
• Patients who were unable to exercise.
• Medically unstable patients.
• Uncooperative patients
Intervention groups
Group 1is Aerobic training group (30 minutes on stationary cycling)
Group 2 is Circuit training group (Stretching of calf and hams (30 sec hold/5 rep), bridging (1 set/5 rep), sit to stand (1 set/5 rep 30 seconds standing in each rep), stationary cycling (5 minute) and walk on parallel bars (5 minute)
Main outcome variables
• Disease severity of ataxic patients is the primary outcome of this study.
• Balance is the secondary outcome of this study.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240323061354N1
Registration date:2024-05-02, 1403/02/13
Registration timing:prospective
Last update:2024-05-02, 1403/02/13
Update count:0
Registration date
2024-05-02, 1403/02/13
Registrant information
Name
Hifza Ahmed
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 2630517
Email address
2022-ms-pt-030@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-03, 1403/02/14
Expected recruitment end date
2024-09-02, 1403/06/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of aerobic training and circuit training on balance and disease severity in ataxic patients
Public title
Comparative effects of aerobic training and circuit training on balance and disease severity in ataxic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants ranging from 30-65 years of age were included in this study (mid adulthood).
Scale for Assessment and Rating of Ataxia (SARA) sitting sub-score was less than or equal to 1 (patients are able to sit and use a stationary exercise bike).
Hemodynamically stable patients.
Patient fall on stage “3 and 4” of Ataxia staging scale.
Patients were able to walk independently with or without assistive device for at least 5 minutes (as a minimum criteria).
Diagnosed ataxic patients
Exclusion criteria:
Patient suffering from recent surgery of low back or lower limb.
Patient encountered any recent musculoskeletal injury (fracture, dislocation, soft tissue injury)
Patients suffering from heart problems/diseases.
Patients who were unable to exercise.
Medically unstable patients.
Uncooperative patients
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling was used to allocate patients. The allocation of the participants was done using lottery method. According to that patients were assigned into group 1 and group 2.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants will be blinded in this study as they will be allocated into groups through the use of lottery method. After carefully selecting individuals for this study, a box will be prepared with the folded chits in it. Those chits will have the names of the participants. Afterwards, a third person (random person) will be asked to draw those chits. The odd number chits will be added in the first treatment group (aerobic training group) and the chits that will be drawn at the even number, added in the second treatment group (circuit training group).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Ethics/ Technical Committee for the University of Faisalabad
Street address
University Avenue, Faisal town, Canal road, Faisalabad.
City
Faisalabad
Postal code
38000
Approval date
2024-02-17, 1402/11/28
Ethics committee reference number
TUF/DR/SA/MSPP/2024/395
Health conditions studied
1
Description of health condition studied
Ataxia due to cerebellar atrophy or degeneration, stroke and multiple sclerosis.
ICD-10 code
G32.81, G3
ICD-10 code description
Cerebellar ataxia in diseases classified elsewhere, Multiple Sclerosis
Primary outcomes
1
Description
Disease severity in ataxia
Timepoint
Before intervention and at the end of 4 weeks of intervention.
Method of measurement
Scale for Assessment and Rating of Ataxia (SARA)
Secondary outcomes
1
Description
Balance
Timepoint
Before intervention and at the end of 4 weeks of intervention.
Method of measurement
Berg balance scale (BBS)
2
Description
Ataxia Staging
Timepoint
Before intervention and at the end of 4 weeks of intervention.
Method of measurement
Functional Staging for Ataxia
Intervention groups
1
Description
Intervention group 1: Aerobic training group (using stationary cycle for 30 minutes duration)
Category
Treatment - Devices
2
Description
Intervention group 2: Circuit training group. Combination of exercises (Stretching of calf and hams (30 sec hold/5 rep), bridging (1 set/5 rep), sit to stand (1 set/5 rep 30 seconds standing in each rep), stationary cycling (5 minute) and walk on parallel bars (5 minute)
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Allied Hospital, Faisalabad.
Full name of responsible person
Sobia Nawaz
Street address
Dr. Tusi Road, Faisalabad.
City
Faisalabad
Postal code
38000
Phone
+92 321 7665101
Email
sobiaaliawan@gmail.com
Web page address
https://ahfsd.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Nisar Fatima
Street address
Sargodha Rd, University Town, Faisalabad.
City
Faisalabad
Postal code
38000
Phone
+92 331 8711448
Email
nisar.fatima@tuf.edu.pk
Web page address
https://tuf.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Faisalabad
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Hifza Ahmed
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 67b Umer Block, Gulshan e Madina Phase 1, Sargodha Rd, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 2630517
Email
hifzaahmed77@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Hifza Ahmed
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 67b Umer Block, Gulshan e Madina Phase 1, Sargodha Rd, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 2630517
Email
2022-ms-pt-030@tuf.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Hifza Ahmed
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 67b Umer Block, Gulshan e Madina Phase 1, Sargodha Rd, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 2630517
Email
hifzaahmed77@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Comparative effects of aerobic training and circuit training on balance and disease severity in ataxic patients
When the data will become available and for how long
Sharing six months after publication and it will remain available for everyone
To whom data/document is available
This will be available for everyone
Under which criteria data/document could be used
nisar.fatima@tuf.edu.pk (0092 331 8711448)
From where data/document is obtainable
hifzaahmed77@gmail.com (0092 304 6887080)
What processes are involved for a request to access data/document
Any applicant just need to contact at email hifzaahmed77@gmail.com (0092 304 6887080) for data/documents.