Functionality, Falls, Elderly, Fall Prevention, Exercise Elderly, Assessment, Rehabilitation, Community-DwellingNCT04358653
Exercise Effectiveness on Fall Risk Factors
A study testing fall prevention exercise program in people with Functionality, Falls, Elderly, Fall Prevention, Exercise Elderly, Assessment, Rehabilitation, Community-Dwelling, run by University of Thessaly at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Functionality, Falls, Elderly, Fall Prevention, Exercise Elderly, Assessment, Rehabilitation, Community-Dwelling
- What is being tested?
- fall prevention exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 3 Oct 2018to 5 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Community-Dwelling Older Adults >65 years old
Who cannot join
- absence of neurological diseases
- absence of dementia
- no recent surgeries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Group Intervention Exercise on Fall Risk Factors Reduction in Community-Dwelling Older Adults
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
Read more
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.
Read the detailed description
Methods Research design
A single - blind, randomized controlled trial design was used to examine the effects of a fall prevention exercise program in reducing fall incidence and fall risks for community-dwelling older adults at a risk for falls. The study was approved by the ethics committee of University of Thessaly.
Sample Forty (40) community dwelling elderly individuals, both males and females, were recruited from nursing homes. Convenience sampling was used. Subject eligibility criteria were: a) 65 years of age and older, b) absence of serious health problems or neurological diseases, c) absence of dementia, d) no recent surgeries. Out of the 40 subjects meeting the above criteria, 20 were randomly assigned to the control group (mean age 79.3±5.49) and 20 to the rehabilitation group (mean age 79.6±7.38). In both groups, 10 subjects reported at least one incidence of falling during the past year whilst the remaining 10 the absence of any.
Base line assessment A structured questionnaire was used to record a) anthropometric and demographic data (age, weight, height, profession etc.), b) comorbid medical conditions (e.g., hypertension, diabetes mellitus, cardiovascular disease, psychiatric illness), c) prescribed medications including psychotropic medications (antidepressants, and sedative hypnotics), d) use of walking aids, e) prior history of falls and fall-related injuries during the past year, f) prior surgeries
Procedure
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. The control group did not receive any intervention during that period and were instructed to pursue their habitual daily life activities.
Instruments and assessments (outcome measures) Participants were assessed prior to the beginning of their program and 15 days after the completion of the intervention. Parameters being assessed were: weight, height, BMI, systolic pressure, diastolic pressure, heart rate, grip strength, upper and lower limb force, plus upper and lower extremity elasticity, equilibrium and functionality.
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)
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)
Grip 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.
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"
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.
For 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) Intervention 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 (hip flexion, extension, abduction, adduction, knee flexion and extension, ankle dorsi and plantar flexion), 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.
Throughout the whole duration of the intervention the elderly subjects were provided with constant feedback for the maintenance of the proper sitting and standing posture.
Breathing rate, blood pressure and heart rate were monitored at every interventional session. All participants were asked to immediately declare any symptom or feeling of dizziness or general discomfort and on that case the current intervention would stop.
- Being tested
- fall prevention exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fall prevention exercise programOther
Also called Exercise Rehabilitation, Group exercise program, Physical exercise therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.
Measured: 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"
Measured: 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)
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start3 Oct 2018
- Primary completion5 Jun 2019
- Study completion5 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functionality, Falls, Elderly, Fall Prevention, Exercise Elderly, Assessment, Rehabilitation, Community-DwellingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Garyfallia Pepera, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358653
- Sponsor's protocol ID
- 118/02-10-2018
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Group Intervention Exercise on Fall Risk Factors Reduction in Community-Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT04358653
- Acronym / sponsor ID
- 118/02-10-2018
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Methods Research design
A single - blind, randomized controlled trial design was used to examine the effects of a fall prevention exercise program in reducing fall incidence and fall risks for community-dwelling older adults at a risk for falls. The study was approved by the ethics committee of University of Thessaly.
Sample Forty (40) community dwelling elderly individuals, both males and females, were recruited from nursing homes. Convenience sampling was used. Subject eligibility criteria were: a) 65 years of age and older, b) absence of serious health problems or neurological diseases, c) absence of dementia, d) no recent surgeries. Out of the 40 subjects meeting the above criteria, 20 were randomly assigned to the control group (mean age 79.3±5.49) and 20 to the rehabilitation group (mean age 79.6±7.38). In both groups, 10 subjects reported at least one incidence of falling during the past year whilst the remaining 10 the absence of any.
Base line assessment A structured questionnaire was used to record a) anthropometric and demographic data (age, weight, height, profession etc.), b) comorbid medical conditions (e.g., hypertension, diabetes mellitus, cardiovascular disease, psychiatric illness), c) prescribed medications including psychotropic medications (antidepressants, and sedative hypnotics), d) use of walking aids, e) prior history of falls and fall-related injuries during the past year, f) prior surgeries
Procedure
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. The control group did not receive any intervention during that period and were instructed to pursue their habitual daily life activities.
Instruments and assessments (outcome measures) Participants were assessed prior to the beginning of their program and 15 days after the completion of the intervention. Parameters being assessed were: weight, height, BMI, systolic pressure, diastolic pressure, heart rate, grip strength, upper and lower limb force, plus upper and lower extremity elasticity, equilibrium and functionality.
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)
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)
Grip 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.
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"
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.
For 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) Intervention 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 (hip flexion, extension, abduction, adduction, knee flexion and extension, ankle dorsi and plantar flexion), 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.
Throughout the whole duration of the intervention the elderly subjects were provided with constant feedback for the maintenance of the proper sitting and standing posture.
Breathing rate, blood pressure and heart rate were monitored at every interventional session. All participants were asked to immediately declare any symptom or feeling of dizziness or general discomfort and on that case the current intervention would stop.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fall prevention exercise program | Experimental | Other: fall prevention exercise programThe 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Community-Dwelling Older Adults >65 years old
Key exclusion criteria (3 listed)
- absence of neurological diseases
- absence of dementia
- no recent surgeries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fall prevention exercise programAlso: Exercise Rehabilitation, Group exercise program, Physical exercise therapyThe 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. | Other | fall prevention exercise program |
Primary outcome
Mobility
Time frame: 8 weeks
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)
Functional balance
Time frame: 8 weeks
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)
Upper Limb Strength
Time frame: 8 weeks
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.
Lower Limb strength
Time frame: 8 weeks
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"
Upper Body Flexibility
Time frame: 8 weeks
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)
Lower Body Flexibility
Time frame: 8 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fall prevention exercise program in people with Functionality, Falls, Elderly, Fall Prevention, Exercise Elderly, Assessment, Rehabilitation, Community-Dwelling, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.