SarcopeniaNCT02942992
Implementing Resistance Exercise to Reduce Frailty for Older Adult
A study testing Resistance exercise in people with Sarcopenia, run by Northwestern University at 1 site in United States.
Trial summary
To develop an intervention specifically targeted for these clients who have the frailty syndrome. The Investigators propose to develop an exercise intervention that can reduce frailty in older adults to facilitate their ability to age-in-place. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2017to 31 Jul 2018
- 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 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Employees of Help at Home, with one eligible client
- aged 65+ years
- receive HCA services two or more days per week
- English-speaking
- not currently participating in regular exercise as defined as 30 minutes three or more days per week, - - no health problems that contraindicate participation in exercise based on the EASY: Exercise Assessment and Screening for You
- Telephone Interview for Cognitive Status score > 26
Who cannot join
- no clients who enroll in the study
- legally blind, no voluntary extremity movement
- physician does not provide clearance for participation
- classified as non-frail based on the SHARE-FI frailty testing
- Telephone Cognitive Status score < 25.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Univiersity Department of Physical Therapy and Human Movement Sciences
Chicago, Illinois, 60611
About this study
Official title: Implementing Resistance Exercise to Reduce Frailty for Older Adult Medicaid Waiver Recipients
To develop an intervention specifically targeted for these clients who have the frailty syndrome. The Investigators propose to develop an exercise intervention that can reduce frailty in older adults to facilitate their ability to age-in-place. The long-term objective of this work is to develop a package of interventions that can be administered within the existing Medicaid Home and Community Based Services (HCBS) Waiver programs. The specific goal of this proposal is to develop a resistance exercise intervention to reduce frailty in older adults receiving long term care services in their home through the Illinois Community Care Program, a HCBS Waiver Program.
- Conditions
- Sarcopenia
- Being tested
- Resistance exercise
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exerciseBehavioural
resistance exercise
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual Care Group |
| Intervention | Other | Intervention Group Receives: Behavioral: Resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with frailty or pre-frailty as assessed by the SHARE-FI
Measured: 26 weeks
Secondary outcomes (2)
Scores of self-reported overall health as measured by the PROMIS-global health
Measured: 26 weeks
Quadriceps muscle strength as assessed by the 30 second chair rise test
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start30 Mar 2017
- Primary completion8 Aug 2017
- Study completion31 Jul 2018
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 SarcopeniaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Danilovich, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942992
- Sponsor's protocol ID
- STU00201777
- Status last verified
- Mar 2019
- First submitted
- 4 Oct 2016
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Danilovich MK, Diaz L, Ciolinio JD, Corcos DM. Functional resistance activities to impact frailty: A protocol for a randomized controlled trial involving home care aide and frail older adult dyads. Contemp Clin Trials Commun. 2017 May 12;7:28-32. doi: 10.1016/j.conctc.2017.05.006. eCollection 2017 Sep.
PubMed 29696165
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Resistance Exercise to Reduce Frailty for Older Adult Medicaid Waiver Recipients
- ClinicalTrials.gov ID
- NCT02942992
- Acronym / sponsor ID
- STU00201777
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 24 Oct 2016 (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.
To develop an intervention specifically targeted for these clients who have the frailty syndrome. The Investigators propose to develop an exercise intervention that can reduce frailty in older adults to facilitate their ability to age-in-place. The long-term objective of this work is to develop a package of interventions that can be administered within the existing Medicaid Home and Community Based Services (HCBS) Waiver programs. The specific goal of this proposal is to develop a resistance exercise intervention to reduce frailty in older adults receiving long term care services in their home through the Illinois Community Care Program, a HCBS Waiver Program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual Care Group |
| Intervention | Other | Behavioral: Resistance exerciseIntervention Group |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Employees of Help at Home, with one eligible client
- aged 65+ years
- receive HCA services two or more days per week
- English-speaking
- not currently participating in regular exercise as defined as 30 minutes three or more days per week, - - no health problems that contraindicate participation in exercise based on the EASY: Exercise Assessment and Screening for You
Key exclusion criteria (5 listed)
- no clients who enroll in the study
- legally blind, no voluntary extremity movement
- physician does not provide clearance for participation
- classified as non-frail based on the SHARE-FI frailty testing
- Telephone Cognitive Status score < 25.
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 |
|---|---|---|
| Resistance exerciseresistance exercise | Behavioural | Intervention |
Primary outcome
Number of participants with frailty or pre-frailty as assessed by the SHARE-FI
Time frame: 26 weeks
2 secondary outcomes
Scores of self-reported overall health as measured by the PROMIS-global health
Time frame: 26 weeks
Quadriceps muscle strength as assessed by the 30 second chair rise test
Time frame: 26 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 13 Mar 2019.
- Derived from this study: PubMed 29696165Danilovich MK, Diaz L, Ciolinio JD, Corcos DM. Functional resistance activities to impact frailty: A protocol for a randomized controlled trial involving home care aide and frail older adult dyads. Contemp Clin Trials Commun. 2017 May 12;7:28-32. doi: 10.1016/j.conctc.2017.05.006. eCollection 2017 Sep.
- Individual participant dataSharing planned: No
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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 Resistance exercise in people with Sarcopenia, run by Northwestern University 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 6 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 13 Mar 2019. 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?
Number of participants with frailty or pre-frailty as assessed by the SHARE-FI (time frame: 26 weeks). 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 NCT02942992, 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 13 Mar 2019.