Exercise Effectiveness on Fall Risk Factors

NCT04358653 | Completed

• 1 other identifier: 118/02-10-2018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To assess the effectiveness of an intervention exercise program on enhancing fall risk deterrent factors, such as balance, postural control, overall strength, functionability in community-dwelling individuals. Design: Single-blinded randomized controlled trial, comparing two groups, with follow-ups at the begging and 15 days after the completion of the program Setting: Nursing homes in Ano Volos and Kanalia Participants: A total of 40 elderly people, both male and female, aged 65 years and older were randomly assigned to an intervention exercise group (n = 20) and a control group (n = 20). Interventions: Intervention exercise program consisted of two sessions each week for 8 consecutive weeks. The control group received no exercise intervention. Measurements: Main outcomes were measured by the Timed Up and Go Test, Berg Balance Scale, 10-second chair stand test, Saehan hand grip dynamometer, Upper and Lower Limp reach tests.

Conditions

Functionality, Falls, Elderly, Fall Prevention, Exercise Elderly, Assessment, Rehabilitation, Community-Dwelling

Outcome Measures

Primary Outcomes (6)

• Mobility

  Mobility was assessed using the Time Up \& Go Test (TUG) which was measured by recording the time taken to stand up from a standard chair (43cm), walk 3m at a natural pace, turn around, and sit back down in the chair. Expected time for the completion of this task is estimated at 7-10''. (Viccaro et al 2011)

  8 weeks

• Functional balance

  Functional balance was assessed with the Berg Balance Scale that has been developed to measure an elderly person's static and dynamic balancing abilities. It is composed of a total of 14 items and a full score of 56 points. The time required is around 15 minutes. Higher scores indicate better degrees of balance. Based on the total score participants are classified in: a) need for a wheelchair (0-20 points), b) need of aiding tools to walk (21-40 points), c) independent (41 points or higher). Persons with scores of 40 points or higher are not likely to fall (Berg et al., 1992 ; Bogle \& Newton 1996; Downs et al 2013)

  8 weeks

• Upper Limb Strength

  Upper Limb Strength was measured using the SAEHAN hand grip dynamometer. The subject was sitting on a standard chair with the elbow flexed at 900. When the subject was ready, he would begin to strain the device in a maximal isometric effort, maintaining, at the same time, high concentration, as this was a required condition for maximal results. No other body movement was allowed during testing.

  8 weeks

• Lower Limb strength

  Lower Limb's strength was assessed through the "sit to stand 10" trial. Subjects were asked to sit on a chair, stand up and return to the sitting position for 10 consecutive times at full speed, with no intervals between. Normal time expected for the successful completion of the trial was estimated at 24"-27"

  8 weeks

• Upper Body Flexibility

  Upper Body Flexibility assessment, subjects were instructed to bring their hand back as high as possible in order to reach the A7 vertebra. The distance between the thumb and the A7 vertebra was measured (Collins et al 2004)

  8 weeks

• Lower Body Flexibility

  Lower Body Flexibility was assessed using a modified Sit and Reach test. This test was performed in a standard chair with one leg fully extended and the other in a flexed position. Participants reached forward with one hand as far as possible and held this position for three seconds. Distance between fingers and toes was measured.

  8 weeks

Study Arms (2)

fall prevention exercise program

EXPERIMENTAL

The experimental group was designed to undergo supervised exercise 2 days a week for 8 consecutive weeks for 45-50 min/session. The intervention program was implemented at the nursing home facilities.

Other: fall prevention exercise program

Control Group

NO INTERVENTION

The control group did not receive any intervention during that period and were instructed to pursue their habitual daily life activities.

Interventions

fall prevention exercise program OTHER

The intervention protocol was starting with a 10 minute warm up (5 minutes circular walking combined with neck rotation in clockwise and counterclockwise fashion and 5 minutes upper and lower limp stretching exercises) and was followed by 30 minutes of exercises that were aiming to muscle strengthening, balance improvement and functionability enhancement. The muscle strengthening routine consisted of exercises both from standing and sitting position using an elastic band, heel and toe standing, upper limb strengthening using dumbbells. Balance training consisted of standing on one leg, shifting weight laterally from one foot to the other, staggered stance, side stepping. Functionalibility improvement was promoted through walking upstairs and downstairs, standing up from sitting to upright position. At the end a 5 minute cool down procedure was following consisting of circular walking, mild head movements and upper and lower body stretching.

Also known as: Exercise Rehabilitation, Group exercise program, Physical exercise therapy

fall prevention exercise program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Community-Dwelling Older Adults \>65 years old

You may not qualify if:

• absence of neurological diseases
• absence of dementia
• no recent surgeries.

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

University of Thessaly

Lamia, 35100, Greece

Location

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 24, 2020
• Study Start: October 3, 2018
• Primary Completion: June 5, 2019
• Study Completion: June 5, 2019
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)