Effect of Osteoanabolic Exercises on Gait, Balance & Fear of Fall Among Osteoporotic Females

NCT04898218 | Completed DMC

• 1 other identifier: Amna Khan
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoporosis

Keywords

Osteoporosis; Bone Mineral Density; Postmenopausal

Outcome Measures

Primary Outcomes (10)

• Gait Velocity

  Temporal Spatial Gait Parameter

  Baseline

• Gait Velocity

  Temporal Spatial Gait Parameter

  12 weeks

• Cadence

  Temporal Spatial Gait Parameter

  Baseline

• Cadence

  Temporal Spatial Gait Parameter

  12 weeks

• Gait Stability Ratio

  Temporal Spatial Gait Parameter

  Baseline

• Gait Stability Ratio

  Temporal Spatial Gait Parameter

  12 weeks

• Balance

  Balance was measured through Timed-up and Go Test

  Baseline

• Balance

  Balance was measured through Timed-up and Go Test

  12 weeks

• 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.

  Baseline

• 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.

  12 weeks

Secondary Outcomes (2)

• Bone Mineral Density

  Baseline

• Bone Mineral Density

  12 weeks

Study Arms (3)

Group A (Aerobic Exercise Group)

ACTIVE COMPARATOR

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.

Other: Exercise

Group B (Resistance Exercise Group)

ACTIVE COMPARATOR

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.

Other: Exercise

Group C (Osteoanabolic Exercise Group)

EXPERIMENTAL

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.

Other: Exercise

Interventions

Exercise OTHER

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.

Group A (Aerobic Exercise Group); Group B (Resistance Exercise Group); Group C (Osteoanabolic Exercise Group)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Gender Eligibility Details: Postmenopausal osteoporotic females screened through PARQ and YOU
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Red flags that limit the recruitment of participants in an exercise program, for example, vertebral fracture, an unstable heart condition, malignancy

Sponsors & Collaborators

• Ziauddin University: lead

Study Sites (1)

Ziauddin University

Karachi, 74700, Pakistan

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Amna Khan

  Ziauddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: May 24, 2021
• Study Start: October 2, 2017
• Primary Completion: November 21, 2018
• Study Completion: December 24, 2018
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)