OsteoporosisNCT02143674
Muscle Strengthening Exercises and Global Stretching in Elderly
A study testing Muscle stretching and Strength Training and Educated about physical exercises in people with Osteoporosis and Senile Osteopenia, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
Introduction: The life expectancy and the number of people hitting the old age have increased in recent years. The aging process is accompanied by morphological and functional changes that contribute to reduced functional capacity, increase the number of falls and the appearance of physical limitations. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Osteoporosis, Senile Osteopenia
- What is being tested?
- Muscle stretching and Strength Training and Educated about physical exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2012to Jan 2014
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women aged over 60 years,
- independent in locomotion,
- with ability to understand verbal commands to perform the tests and participation in the treatment program
Who cannot join
- execution of other physical activities or doing other types of physical therapy,
- had any prior neurological deficit (stroke, traumatic brain injury, Parkinson's disease) or
- musculoskeletal diseases which compromising performance and mobility,
- use of orthosis for locomotion,
- inability to perform the evaluation tests and/or participation in the intervention session
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratory of Kinesiotherapy and Manual Therapeutic Resources, Department of Physical Therapy, Federal University of Pernambuco (UFPE)
Recife, Pernambuco, 50670-901
About this study
Official title: MUSCLE STRENGTHENING EXERCISES AND GLOBAL STRETCHING: IMPACT ON BALANCE, FEAR OF FALLING AND FUNCTIONAL CAPACITY OF ELDERLY
Introduction: The life expectancy and the number of people hitting the old age have increased in recent years. The aging process is accompanied by morphological and functional changes that contribute to reduced functional capacity, increase the number of falls and the appearance of physical limitations. Exercise promotes maintenance of functional autonomy, improving the physical ability of the elderly making it more independent.
Objective: To evaluate the effect of a program of muscle strengthening exercises associated with global stretching on balance, fear of falling and functional capacity in elderly women.
Methods: This was a non-randomized controlled trial, in which 12 volunteers aged over 60 years were divided into two groups: intervention group (IG, n = 7) submitted to muscle strengthening exercises and stretching, 2 times per week for 12 weeks, and the control group (CG, n = 5), not submitted to the protocol but were educated about physical exercises. Before and after the protocol were evaluated scores of Berg Balance Scale, the Falls Efficacy Scale International (FES-I) and Evaluation of Functional Autonomy Development Group for Latin American Maturity (GDLAM). Data were statistically analyzed within and between groups with a significance level of p <0.05.
- Conditions
- Osteoporosis, Senile Osteopenia
- Being tested
- Muscle stretching and Strength Training, Educated about physical exercises
- Keywords
- Stretching exercise muscle, Elderly, Techniques and exercise, Physiotherapy
- Medical subject headings
- Osteoporosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle stretching and Strength TrainingOther
Each step of stretching on specific muscles was repeated three times by keeping the posture for 30 seconds, (Arnold and Kokkonen, 2007; Toraman A, Yildirim. 2010; Dai, Ware, Giuliani, 2012; Duque et al., 2013; Granacher et al., 2013). The Pectoral, Quadriceps, Paraspinal, Abdominal and Ischial tibial and sural triceps muscles were elongated.
Strength Training Muscle strengthening was performed using weights and dumbbells. The training load individually determined through the test of strength with 10 repetitions maximum. The load was reevaluated four weeks of training. The Abdominal, Paraspinal, Quadriceps and Posterior thigh muscles (hamstrings) were submitted to the intervention protocol.
Educated about physical exercisesOther
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTION | Experimental | Muscle stretching and Strength Training Receives: Other: Muscle stretching and Strength Training |
| Educated about physical exercises | Experimental | Not described Receives: Other: Educated about physical exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
balance score
Berg Balance Scale (BBS)
Measured: 12 weeks
Secondary outcomes (2)
Fear of falling score
Falls Efficacy Scale International (FES-I)
Measured: 12 weeks
Functional Capacity
Evaluation of the Latin American Functional Autonomy Development Group for Maturity (GDLAM)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startSep 2012
- Primary completionNov 2012
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Ciência e Tecnologia de Pernambuco
- Responsible party
- Principal investigator, Maria das Graças Rodrigues de Araújo, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143674
- Sponsor's protocol ID
- UFPernambuco
- Other IDs
- UFPE CAAE N.130.281
- Status last verified
- May 2014
- First submitted
- 27 Feb 2014
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MUSCLE STRENGTHENING EXERCISES AND GLOBAL STRETCHING: IMPACT ON BALANCE, FEAR OF FALLING AND FUNCTIONAL CAPACITY OF ELDERLY
- ClinicalTrials.gov ID
- NCT02143674
- Acronym / sponsor ID
- UFPernambuco
- Conditions
- Osteoporosis, Senile Osteopenia
- Keywords
- Stretching exercise muscle, Elderly, Techniques and exercise, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Ciência e Tecnologia de Pernambuco
- Study start
- Sep 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 21 May 2014 (estimated)
- 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.
Introduction: The life expectancy and the number of people hitting the old age have increased in recent years. The aging process is accompanied by morphological and functional changes that contribute to reduced functional capacity, increase the number of falls and the appearance of physical limitations. Exercise promotes maintenance of functional autonomy, improving the physical ability of the elderly making it more independent.
Objective: To evaluate the effect of a program of muscle strengthening exercises associated with global stretching on balance, fear of falling and functional capacity in elderly women.
Methods: This was a non-randomized controlled trial, in which 12 volunteers aged over 60 years were divided into two groups: intervention group (IG, n = 7) submitted to muscle strengthening exercises and stretching, 2 times per week for 12 weeks, and the control group (CG, n = 5), not submitted to the protocol but were educated about physical exercises. Before and after the protocol were evaluated scores of Berg Balance Scale, the Falls Efficacy Scale International (FES-I) and Evaluation of Functional Autonomy Development Group for Latin American Maturity (GDLAM). Data were statistically analyzed within and between groups with a significance level of p <0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION | Experimental | Other: Muscle stretching and Strength TrainingMuscle stretching and Strength Training |
| Educated about physical exercises | Experimental | Other: Educated about physical exercises |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women aged over 60 years,
- independent in locomotion,
- with ability to understand verbal commands to perform the tests and participation in the treatment program
Key exclusion criteria (5 listed)
- execution of other physical activities or doing other types of physical therapy,
- had any prior neurological deficit (stroke, traumatic brain injury, Parkinson's disease) or
- musculoskeletal diseases which compromising performance and mobility,
- use of orthosis for locomotion,
- inability to perform the evaluation tests and/or participation in the intervention session
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 |
|---|---|---|
| Muscle stretching and Strength TrainingEach step of stretching on specific muscles was repeated three times by keeping the posture for 30 seconds, (Arnold and Kokkonen, 2007; Toraman A, Yildirim. 2010; Dai, Ware, Giuliani, 2012; Duque et al., 2013; Granacher et al., 2013). The Pectoral, Quadriceps, Paraspinal, Abdominal and Ischial tibial and sural triceps muscles were elongated. Strength Training Muscle strengthening was performed using weights and dumbbells. The training load individually determined through the test of strength with 10 repetitions maximum. The load was reevaluated four weeks of training. The Abdominal, Paraspinal, Quadriceps and Posterior thigh muscles (hamstrings) were submitted to the intervention protocol. | Other | INTERVENTION |
| Educated about physical exercises | Other | Educated about physical exercises |
Primary outcome
balance score
Time frame: 12 weeks
Berg Balance Scale (BBS)
2 secondary outcomes
Fear of falling score
Time frame: 12 weeks
Functional Capacity
Time frame: 12 weeks
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 21 May 2014.
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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 Muscle stretching and Strength Training and Educated about physical exercises in people with Osteoporosis and Senile Osteopenia, run by Universidade Federal de Pernambuco at 1 site in Brazil.
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 3 inclusion and 5 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 21 May 2014. 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 Brazil. 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?
balance score (time frame: 12 weeks). 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 21 May 2014.