To determine the comparative effects of high and low intensity resistance training on balance and fatigue perception in patients with Parkinson's disease.
Design
Parallel group, single-blind, randomized controlled trial on 44 individuals
Settings and conduct
A study was conducted in Physiotherapy Department at District Headquarter Hospital (DHQ) Sheikhupura. A single blinded study and participants were blinded through chit method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: both male and female; 50-65 years old people; Parkinson's disease. Exclusion criteria: cognitive impairments; diagnosed by any other neurological conditions.
Intervention groups
Patients allocated to Group A performed a low-intensity exercise program that included breathing, stretching, and relaxation in a sitting position twice a week for 12 consecutive weeks. In contrast, Participants located in Group B went through high-intensity exercises with Thera-bands twice a week for 12 consecutive weeks with individualized progression. Each session ended up in 60 min. The standard training program included a 5-10 min warm-up session, core activities, and a 5-min cool-down. Outcomes were measured by two scales, Mini-Bestest and Revised Piper Fatigue Scale.
Comparative effects of high and low intensity resistance training on balance and fatigue perception in patients with Parkinson’s Disease
Public title
Comparative effects of high and low intensity resistance training on balance and fatigue perception in patients with Parkinson’s Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
use stable medicine
able to walk 10 m without any kind of assistant either by a person or a walking frame.
Exclusion criteria:
cognitive impairment (Mini-Mental State Examination score lower than 24)
comprehension deficits that prevented them from following verbal commands
have visual or acoustic limitations
diagnosed by any neurological condition other than PD, or other clinical comorbidities that affect the gait
Age
From 50 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
44
More than 1 sample in each individual
Number of samples in each individual:
3
Samples were taken 3 times from both group. First time as a baseline. 2nd time after 6 weeks of treatment and third time again after 6 weeks of treatment
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method used. Both group A and B randomized. Participants with Parkinson's Disease in both A and B group randomly selected after matching inclusion criteria through chit method. Random sequence was built by appointing Even numbers to the group A and odd numbers to group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants of both groups were blinded in this study through chit method. We had 2 chits on one Group A were written and on other Group B and once they matched the inclusion criteria we gave them both sealed chit and said to choose one. We share general information about the intervention and study protocol with participants of both groups. Participants were informed that they would be randomly allocated into one of the groups and would receive different exercises and Physiotherapy interventions as treatment. Only information about high and low-intensity exercises. After group allocation, they were informed about the detailed intervention plan of their group. Timing of sessions of both groups participants were different to avoid the unintended meetup of the participants.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Lahore
Street address
University of Lahore, 1 km, Defence Road, Off Bhobatian Chowk, Lahore
City
Lahore
Postal code
55150
Approval date
2020-12-03, 1399/09/13
Ethics committee reference number
IRB-UOL-FAHS/798/2020
Health conditions studied
1
Description of health condition studied
Parkinson's Disease
ICD-10 code
G20
ICD-10 code description
Parkinson's Disease
Primary outcomes
1
Description
Balance and Fatigue
Timepoint
baseline, 6 weeks after intervention and 12 weeks after intervention
Method of measurement
Mini-BESTest and Piper Fatigue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Group A (Intervention group): 22 patients allocated to the Group A performed low-intensity exercise program which include breathing, stretching and relaxation activities in a sitting position twice a week for 12 consecutive weeks. Each session ended-up in 60 min. The standard training program included 5-10 min warm-up session, core activities and 5-min cool-down.
Category
Rehabilitation
2
Description
Group B (Intervention group): 22 participants allocated in Group B randomly. Participants allocated to the Group B gone through high intensity resistance training program with thera-bands twice a week for 12 consecutive weeks with individualized progression. Each session ended-up in 60 min. The standard training program included 5-10 min warm-up session, core activities and 5-min cool-down.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
District Headquarter Hospital
Full name of responsible person
Dr. Imran Manzoor Bhatti
Street address
PX6H+PGF, Sheikhupura, Punjab
City
Sheikhupura
Postal code
39350
Phone
+92 56 9200234
Email
info@dhqskp.punjab.gov.pk
Web page address
https://dhqsheikhupura.punjab.gov.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Dr. Ashfaq Ahmed
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Postal code
55150
Phone
+92 42 111 865 865
Email
ashfaq.ahmed@uipt.uol.edu.pk
Web page address
https://uol.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 Lahore
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
PK
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Rida Naqvi
Position
Postgraduate Resident
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 42 111 865 865
Email
naqviridz@gmail.com
Web page address
https://uol.edu.pk/
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Rida Naqvi
Position
Postgraduate Resident
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 42 111 865 865
Email
naqviridz@gmail.com
Web page address
https://uol.edu.pk/
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Rida Naqvi
Position
Postgraduate Resident
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
1-Km Defence Road،, near Bhuptian Chowk،, Lahore, Punjab
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 42 111 865 865
Email
naqviridz@gmail.com
Web page address
https://uol.edu.pk/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD