Back to resultsEffect of Osteoanabolic Exercises on Gait, Balance & Fear of Fall Among Osteoporotic Females
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, Bone Mineral Density, Postmenopausal
Eligibility Criteria
Inclusion Criteria:
- Postmenopausal osteoporotic females aged in between 50-75 years
- Not participating in any exercise program for the past 3 months
- Independently ambulatory were included in the study
Exclusion Criteria:
• Red flags that limit the recruitment of participants in an exercise program, for example, vertebral fracture, an unstable heart condition, malignancy
Sites / Locations
- Ziauddin University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Group A (Aerobic Exercise Group)
Group B (Resistance Exercise Group)
Group C (Osteoanabolic Exercise Group)
Arm Description
Warm-up exercises were performed by the participants on a cycle ergometer for a duration of 5-10 minutes. Group A was advised to start walking at a comfortable speed on a treadmill for the duration of 30-60 minutes; the intensity of the exercises was 55-75% of MHR, calculated by using a Karvonen method. Initially with the minimum intensity that was gradually raised up to the intensity of Targeted Heart Rate (THR). Once the THR is achieved the intensity was gradually decelerated and patient proceeded for the cool-down phase for 5-10 min.
Group B was instructed for strengthening exercises of ten major muscle groups that include Biceps, Triceps, Pectoralis Major, Deltoid, Latissimus Dorsi, Abdominals, Back Extensors, Hamstrings, Quadriceps and Calf. The intensity of the weight-bearing exercises was calculated using 1 Repetition Maximum (RM) method.
Group C was performed Osteoanabolic exercise divided into two different phases: Aerobic Conditioning Phase Participants were instructed to walk on treadmill for 30-60 min. The intensity of the exercises was 55-75% MHR, calculated by Karvonen method. Intensity gradually raised up to the Targeted Heart Rate (THR). Once the THR is achieved the intensity was gradually decelerated and patient proceeded for the cool-down phase. The participants performed 3 days per week for 12 weeks on alternative days. Anaerobic (Resistance) Conditioning Phase Resistance training was started on every alternative day of the aerobic conditioning (3 days per week) for 45 min. The intensity of the weight-bearing exercises was calculated using 1 RM method. Resistance training muscle and protocol was the same as for Group B. The participants performed warm-up and cool down similar to that of group A and group B.
Outcomes
Primary Outcome Measures
Gait Velocity
Temporal Spatial Gait Parameter
Gait Velocity
Temporal Spatial Gait Parameter
Cadence
Temporal Spatial Gait Parameter
Cadence
Temporal Spatial Gait Parameter
Gait Stability Ratio
Temporal Spatial Gait Parameter
Gait Stability Ratio
Temporal Spatial Gait Parameter
Balance
Balance was measured through Timed-up and Go Test
Balance
Balance was measured through Timed-up and Go Test
Fear of Fall
Measured through Fall Efficacy Scale- International consisting of 16 items that are summed to calculate a total score from minimum 16 to maximum 64. Higher the score, greater the fear of falling.
Fear of Fall
Measured through Fall Efficacy Scale- International consisting of 16 items that are summed to calculate a total score from minimum 16 to maximum 64. Higher the score, greater the fear of falling.
Secondary Outcome Measures
Bone Mineral Density
Measured through Peripheral DXA Scan on right side calcaneal bone
Bone Mineral Density
Measured through Peripheral DXA Scan on right side calcaneal bone
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04898218
Brief Title
Effect of Osteoanabolic Exercises on Gait, Balance & Fear of Fall Among Osteoporotic Females
Official Title
Effect of Osteoanabolic Exercises on Gait, Balance & Fear of Fall Among Osteoporotic Females
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
November 21, 2018 (Actual)
Study Completion Date
December 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziauddin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
With the increase in life expectancy women spend more than one-third of their life time in post-menopausal state leading to osteoporosis in later stages. Therefore a decrease in temporal-spatial parameters of gait, high risk of fracture, imbalance in functional parameters, fear of fall and compromised health-related quality of life is observed among osteoporotic females. Several physical activities and balance training programs have been implemented globally but nationally no program has yet been designed catering gait balance and fear of fall altogether as a combined program. Therefore, the aim of this study was to determine the effectiveness of Osteoanabolic exercises on Temporal-Spatial gait parameters, Gait Stability Ratio (GSR) and Bone Mineral Density (BMD) among the osteoporotic females. Moreover, the effectiveness of these exercises was evaluated on dynamic balance using Timed Up and Go Test (TUG).
Furthermore, the impact on fear of fall was identified using Fall Efficacy ScaleInternational (FES-I).
Detailed Description
A 3-arm Randomized Controlled Trial was conducted at the Department of Rehabilitation Sciences, Ziauddin Hospital using the envelope method. The participants were screened on the Physical Activity Readiness and You Questionnaire (PARQ &YOU). Ninety-three osteoporotic females were randomly allocated into three groups; where; participant in group A' received aerobic training protocol, a participant in group B' resistance training and participant in group C' Osteoanabolic training. A Frequency Intensity Time Type (FITT) protocol according to the American College of Sports Medicine for aerobic and resistance training was incorporated whereas for Osteoanabolic group combination training protocol was used. Twelve weeks of training was conducted where pre and post readings were calculated using activPAL, TUG, FES-I and Peripheral DXA Scan.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Osteoporosis, Bone Mineral Density, Postmenopausal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A (Aerobic Exercise Group)
Arm Type
Active Comparator
Arm Description
Warm-up exercises were performed by the participants on a cycle ergometer for a duration of 5-10 minutes. Group A was advised to start walking at a comfortable speed on a treadmill for the duration of 30-60 minutes; the intensity of the exercises was 55-75% of MHR, calculated by using a Karvonen method. Initially with the minimum intensity that was gradually raised up to the intensity of Targeted Heart Rate (THR). Once the THR is achieved the intensity was gradually decelerated and patient proceeded for the cool-down phase for 5-10 min.
Arm Title
Group B (Resistance Exercise Group)
Arm Type
Active Comparator
Arm Description
Group B was instructed for strengthening exercises of ten major muscle groups that include Biceps, Triceps, Pectoralis Major, Deltoid, Latissimus Dorsi, Abdominals, Back Extensors, Hamstrings, Quadriceps and Calf. The intensity of the weight-bearing exercises was calculated using 1 Repetition Maximum (RM) method.
Arm Title
Group C (Osteoanabolic Exercise Group)
Arm Type
Experimental
Arm Description
Group C was performed Osteoanabolic exercise divided into two different phases:
Aerobic Conditioning Phase Participants were instructed to walk on treadmill for 30-60 min. The intensity of the exercises was 55-75% MHR, calculated by Karvonen method. Intensity gradually raised up to the Targeted Heart Rate (THR). Once the THR is achieved the intensity was gradually decelerated and patient proceeded for the cool-down phase. The participants performed 3 days per week for 12 weeks on alternative days.
Anaerobic (Resistance) Conditioning Phase Resistance training was started on every alternative day of the aerobic conditioning (3 days per week) for 45 min. The intensity of the weight-bearing exercises was calculated using 1 RM method. Resistance training muscle and protocol was the same as for Group B. The participants performed warm-up and cool down similar to that of group A and group B.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
The exercises were performed for 12 weeks, for the maximum of 6 days/week for Osteoanabolic group, 5 days/week for aerobic group and 3 days/ week for a resistance group as per ACSM, FITT protocol.
Primary Outcome Measure Information:
Title
Gait Velocity
Description
Temporal Spatial Gait Parameter
Time Frame
Baseline
Title
Gait Velocity
Description
Temporal Spatial Gait Parameter
Time Frame
12 weeks
Title
Cadence
Description
Temporal Spatial Gait Parameter
Time Frame
Baseline
Title
Cadence
Description
Temporal Spatial Gait Parameter
Time Frame
12 weeks
Title
Gait Stability Ratio
Description
Temporal Spatial Gait Parameter
Time Frame
Baseline
Title
Gait Stability Ratio
Description
Temporal Spatial Gait Parameter
Time Frame
12 weeks
Title
Balance
Description
Balance was measured through Timed-up and Go Test
Time Frame
Baseline
Title
Balance
Description
Balance was measured through Timed-up and Go Test
Time Frame
12 weeks
Title
Fear of Fall
Description
Measured through Fall Efficacy Scale- International consisting of 16 items that are summed to calculate a total score from minimum 16 to maximum 64. Higher the score, greater the fear of falling.
Time Frame
Baseline
Title
Fear of Fall
Description
Measured through Fall Efficacy Scale- International consisting of 16 items that are summed to calculate a total score from minimum 16 to maximum 64. Higher the score, greater the fear of falling.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Bone Mineral Density
Description
Measured through Peripheral DXA Scan on right side calcaneal bone
Time Frame
Baseline
Title
Bone Mineral Density
Description
Measured through Peripheral DXA Scan on right side calcaneal bone
Time Frame
12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postmenopausal osteoporotic females screened through PARQ and YOU
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Postmenopausal osteoporotic females aged in between 50-75 years
Not participating in any exercise program for the past 3 months
Independently ambulatory were included in the study
Exclusion Criteria:
• Red flags that limit the recruitment of participants in an exercise program, for example, vertebral fracture, an unstable heart condition, malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amna Khan
Organizational Affiliation
Ziauddin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziauddin University
City
Karachi
ZIP/Postal Code
74700
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Osteoanabolic Exercises on Gait, Balance & Fear of Fall Among Osteoporotic Females
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