Frail ElderlyNCT00105781
Nurse Physical Activity Counseling in Primary Care
A study testing Exercise counseling in people with Frail Elderly and Aged, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Aging veterans with functional impairments followed in primary care clinics were randomized to counseling for a walking plus strength exercise home-based exercise program or to health education by a nurse. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Frail Elderly, Aged, Physical Fitness
- What is being tested?
- Exercise counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Feb 2006
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referred by primary care providers in VA primary care clinics. Interested and willing to try to increase physical activity. Some self-reported or observed impairments in physical function. Excluded if there are health conditions that make home-based exercise not appropriate. Observed or self-reported physical function impairment Able to walk for health Living independently in community Able to return to VA MedicalCenter for research visits Enrolled in primary care Access to telephone
Who cannot join
- Any of these within 6 months: myocardial infarction, congestive heart failure, TIA or stroke, leg fracture, seizure, uncontrolled arrhythmia, unstable angina Uncontrolled diabetes, hypertension, dyslipidemia FEV1 less than 1.5 Any condition that provider believes would make unsupervised exercise unsafe
Trial locations and contacts
1 site in 1 country.
United States1 site
G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
Jacksonport, Arkansas, 39216
About this study
Aging veterans with functional impairments followed in primary care clinics were randomized to counseling for a walking plus strength exercise home-based exercise program or to health education by a nurse. Exercise participants attended 3 intervention sessions totaling about 100 minutes of contact with the nurse and a physical therapy assistant over 10 months. They were also asked to record walking and strength exercise on monthly calendars and received motivational automated phone messages. Education control patients discussed health topics of their choice with the nurse. Materials were based on National Institute of Aging materials currently available on the internet. After 10 months, the exercise participants reported more time spent in walking and strength exercise and accelerometer data indicated a greater increase in time spent in moderate or higher intensity activity per day. Participants who engaged in strength exercises improved more on functional fitness tests and quality of life after 10 months. Analyses from the cognitive sub-study remain incomplete.
Read the detailed description
Description Background: Many older individuals are at high risk for health complications and functional impairment due to low levels of physical activity. Walking is an acceptable and safe activity associated with many health benefits. Strength and flexibility exercises are also important components of the exercise prescription for optimal health and function in the elderly. Developing interventions to promote healthy physical activity is a current public health priority, and counseling by providers in health care settings is a promising approach. Objectives: The primary objective was to evaluate the effects of nurse counseling on total weekly minutes and frequency of home-based walking and strength/flexibility exercises. Secondary objectives included evaluating physical function and accelerometer physical activity. A sub-study initiated in April 2004 examined the association between exercise and cognitive functioning. Methods: The design is a randomized clinical trial. Outcomes were assessed at 5 months (end of initiation phase) and 10 months (maintenance). Clinic-based exercise counseling was delivered by a nurse and physical therapy assistant at baseline and a 1-month follow-up. Interventions were based on exercise for people over 50 information available on the National Institute on Aging internet website. VA primary care patients aged 60 to 85 referred by their primary care provider were assigned to one of 2 conditions: a) exercise counseling or b) health education contact control. All participants received preventive health counseling emphasizing safety and falls prevention. The exercise counseling group also received follow-up phone contacts, including automated motivational messages, from the nurse. All participants had continuing contact with research staff but were exposed to different specific intervention components. . Status: Data collection complete; additional analyses in progress.
- Conditions
- Frail Elderly, Aged, Physical Fitness
- Being tested
- Exercise counseling
- Keywords
- Nurses, Telephone, Counseling, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise counselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Exercise counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minutes and days per week of walking and strength training exercise at 5 and 10
Secondary outcomes (1)
Functional fitness tests, Accelerometer activity, Quality of Life, and Cognitive performance in sub-sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2005 (estimated)
- Study startNov 2002
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frail ElderlyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Patricia M. Dubbert, PhD, Principal investigator, G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105781
- Sponsor's protocol ID
- NRI 99-334
- Status last verified
- May 2007
- First submitted
- 16 Mar 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Dubbert PM, Morey MC, Kirchner KA, Meydrech EF, Grothe K. Counseling for home-based walking and strength exercise in older primary care patients. Arch Intern Med. 2008 May 12;168(9):979-86. doi: 10.1001/archinte.168.9.979.
PubMed 18474762
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse Physical Activity Counseling in Primary Care
- ClinicalTrials.gov ID
- NCT00105781
- Acronym / sponsor ID
- NRI 99-334
- Conditions
- Frail Elderly, Aged, Physical Fitness
- Keywords
- Nurses, Telephone, Counseling, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Nov 2002
- Study completion
- Feb 2006 (actual)
- First posted
- 17 Mar 2005 (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.
Aging veterans with functional impairments followed in primary care clinics were randomized to counseling for a walking plus strength exercise home-based exercise program or to health education by a nurse. Exercise participants attended 3 intervention sessions totaling about 100 minutes of contact with the nurse and a physical therapy assistant over 10 months. They were also asked to record walking and strength exercise on monthly calendars and received motivational automated phone messages. Education control patients discussed health topics of their choice with the nurse. Materials were based on National Institute of Aging materials currently available on the internet. After 10 months, the exercise participants reported more time spent in walking and strength exercise and accelerometer data indicated a greater increase in time spent in moderate or higher intensity activity per day. Participants who engaged in strength exercises improved more on functional fitness tests and quality of life after 10 months. Analyses from the cognitive sub-study remain incomplete.
Detailed description
Description Background: Many older individuals are at high risk for health complications and functional impairment due to low levels of physical activity. Walking is an acceptable and safe activity associated with many health benefits. Strength and flexibility exercises are also important components of the exercise prescription for optimal health and function in the elderly. Developing interventions to promote healthy physical activity is a current public health priority, and counseling by providers in health care settings is a promising approach. Objectives: The primary objective was to evaluate the effects of nurse counseling on total weekly minutes and frequency of home-based walking and strength/flexibility exercises. Secondary objectives included evaluating physical function and accelerometer physical activity. A sub-study initiated in April 2004 examined the association between exercise and cognitive functioning. Methods: The design is a randomized clinical trial. Outcomes were assessed at 5 months (end of initiation phase) and 10 months (maintenance). Clinic-based exercise counseling was delivered by a nurse and physical therapy assistant at baseline and a 1-month follow-up. Interventions were based on exercise for people over 50 information available on the National Institute on Aging internet website. VA primary care patients aged 60 to 85 referred by their primary care provider were assigned to one of 2 conditions: a) exercise counseling or b) health education contact control. All participants received preventive health counseling emphasizing safety and falls prevention. The exercise counseling group also received follow-up phone contacts, including automated motivational messages, from the nurse. All participants had continuing contact with research staff but were exposed to different specific intervention components. . Status: Data collection complete; additional analyses in progress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Exercise counseling |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Referred by primary care providers in VA primary care clinics. Interested and willing to try to increase physical activity. Some self-reported or observed impairments in physical function. Excluded if there are health conditions that make home-based exercise not appropriate. Observed or self-reported physical function impairment Able to walk for health Living independently in community Able to return to VA MedicalCenter for research visits Enrolled in primary care Access to telephone
Key exclusion criteria (1 listed)
- Any of these within 6 months: myocardial infarction, congestive heart failure, TIA or stroke, leg fracture, seizure, uncontrolled arrhythmia, unstable angina Uncontrolled diabetes, hypertension, dyslipidemia FEV1 less than 1.5 Any condition that provider believes would make unsupervised exercise unsafe
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 |
|---|---|---|
| Exercise counseling | Behavioural | Arm 1 |
Primary outcome
Minutes and days per week of walking and strength training exercise at 5 and 10
1 secondary outcome
Functional fitness tests, Accelerometer activity, Quality of Life, and Cognitive performance in sub-sample
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 7 Apr 2015.
- Results publication: PubMed 18474762Dubbert PM, Morey MC, Kirchner KA, Meydrech EF, Grothe K. Counseling for home-based walking and strength exercise in older primary care patients. Arch Intern Med. 2008 May 12;168(9):979-86. doi: 10.1001/archinte.168.9.979.
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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.
Patricia M. Dubbert, PhD principal investigator
G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise counseling in people with Frail Elderly and Aged, run by US Department of Veterans Affairs at 1 site in United States.
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 1 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 7 Apr 2015. 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 United States. 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?
Minutes and days per week of walking and strength training exercise at 5 and 10. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00105781, which also lists 1 linked publication.
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 7 Apr 2015.