Older AdultsCDA-SRNCT03039556
Step-reduction in Older Men and Women
A study testing Normal Daily Steps, Step-Reduction and Return to Normal Daily Steps in people with Older Adults and Reduced Physical Activity, run by McMaster University at 1 site in Canada.
Trial summary
This study investigates the effects of two weeks of reduced daily ambulation and a subsequent return to normal physical activity on metabolic health of older adults. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults, Reduced Physical Activity
- What is being tested?
- Normal Daily Steps, Step-Reduction and Return to Normal Daily Steps
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to May 2016
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Non-smoker
Who cannot join
- Use of assistive walking devices
- Chronic use of analgesic or anti-inflammatory drugs
- History of neuromuscular problems or muscle and/or bone wasting disease
- Acute or chronic illness including cardiac, pulmonary, liver or kidney abnormalities, uncontrolled hypertension, insulin or non-insulin dependent diabetes or other metabolic disorders
- Daily use of statins, particularly simvastatin and atorvastatin
- Use of medications known to affect protein metabolism
- Normally complete fewer than 3000 steps per day
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Metabolism Research Laboratory, McMaster Univeristy
Hamilton, Ontario, L8S 4K1
About this study
Official title: The Influence of Acute Physical Inactivity on Metabolic Function in Older Men and Women
This study investigates the effects of two weeks of reduced daily ambulation and a subsequent return to normal physical activity on metabolic health of older adults.
Read the detailed description
Aging results in a progressive loss of muscle mass that is accelerated by periods of muscular disuse, common for older adults during hospitalization or convalescence from illness. Transient physical inactivity has been shown to cause muscular atrophy and impairments in insulin sensitivity in both younger and older adults. However, the recovery capacity of older adults after such physical inactivity remains unknown. This study aims to determine the impact of two weeks of daily step reduction to ≤1000 steps per day, an experimental model mimicking short-term physical inactivity, on glycemic control in older adults and further investigate whether older adults are able to recover from the consequences of this inactivity simply by returning to their habitual activity for 14 days.
- Conditions
- Older Adults, Reduced Physical Activity
- Being tested
- Normal Daily Steps, Step-Reduction, Return to Normal Daily Steps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Daily StepsBehavioural
Complete normal daily ambulation for one week
Step-ReductionBehavioural
Reduce daily ambulation to fewer than 1000 steps per day for two weeks
Return to Normal Daily StepsBehavioural
Increase daily ambulation to 100% of normal daily step-count for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Change in physical activity for older adults | Experimental | Older adult participants undergo alterations in daily ambulation by completing Normal Daily Steps for one week, followed by a two-week Step-Reduction and a subsequent Return to Normal Daily Steps for two weeks Receives: Behavioral: Normal Daily Steps; Behavioral: Step-Reduction; Behavioral: Return to Normal Daily Steps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insulin Sensitivity
Assessed via Matsuda ISI
Measured: Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)
Secondary outcomes (3)
Change in lean tissue mass
Assessed via Dual Energy X-Ray Absorptiometry
Measured: Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)
Change in Peak Isometric Maximal Voluntary Leg Extension Strength
Assessed via muscle dynamometry
Measured: Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)
Change in Muscle Protein Synthesis
Obtained via vastus lateralis muscle biopsy
Measured: Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study startSep 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- More trials run by McMaster 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Diabetes Association
- Responsible party
- Principal investigator, Stuart Phillips, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039556
- Sponsor's protocol ID
- 0574
- Acronym
- CDA-SR
- Status last verified
- Jan 2017
- First submitted
- 13 Jan 2017
- Last updated
- 1 Feb 2017
- Results posted
- No
Publications
Breen L, Stokes KA, Churchward-Venne TA, Moore DR, Baker SK, Smith K, Atherton PJ, Phillips SM. Two weeks of reduced activity decreases leg lean mass and induces "anabolic resistance" of myofibrillar protein synthesis in healthy elderly. J Clin Endocrinol Metab. 2013 Jun;98(6):2604-12. doi: 10.1210/jc.2013-1502. Epub 2013 Apr 15.
PubMed 23589526Devries MC, Breen L, Von Allmen M, MacDonald MJ, Moore DR, Offord EA, Horcajada MN, Breuille D, Phillips SM. Low-load resistance training during step-reduction attenuates declines in muscle mass and strength and enhances anabolic sensitivity in older men. Physiol Rep. 2015 Aug;3(8):e12493. doi: 10.14814/phy2.12493.
PubMed 26265753McGlory C, von Allmen MT, Stokes T, Morton RW, Hector AJ, Lago BA, Raphenya AR, Smith BK, McArthur AG, Steinberg GR, Baker SK, Phillips SM. Failed Recovery of Glycemic Control and Myofibrillar Protein Synthesis With 2 wk of Physical Inactivity in Overweight, Prediabetic Older Adults. J Gerontol A Biol Sci Med Sci. 2018 Jul 9;73(8):1070-1077. doi: 10.1093/gerona/glx203.
PubMed 29095970
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Acute Physical Inactivity on Metabolic Function in Older Men and Women
- ClinicalTrials.gov ID
- NCT03039556
- Acronym / sponsor ID
- CDA-SR / 0574
- Conditions
- Older Adults, Reduced Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Diabetes Association
- Study start
- Sep 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 1 Feb 2017 (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.
This study investigates the effects of two weeks of reduced daily ambulation and a subsequent return to normal physical activity on metabolic health of older adults.
Detailed description
Aging results in a progressive loss of muscle mass that is accelerated by periods of muscular disuse, common for older adults during hospitalization or convalescence from illness. Transient physical inactivity has been shown to cause muscular atrophy and impairments in insulin sensitivity in both younger and older adults. However, the recovery capacity of older adults after such physical inactivity remains unknown. This study aims to determine the impact of two weeks of daily step reduction to ≤1000 steps per day, an experimental model mimicking short-term physical inactivity, on glycemic control in older adults and further investigate whether older adults are able to recover from the consequences of this inactivity simply by returning to their habitual activity for 14 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Change in physical activity for older adults | Experimental | Behavioral: Normal Daily Steps, Behavioral: Step-Reduction, Behavioral: Return to Normal Daily StepsOlder adult participants undergo alterations in daily ambulation by completing Normal Daily Steps for one week, followed by a two-week Step-Reduction and a subsequent Return to Normal Daily Steps for two weeks |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Non-smoker
Key exclusion criteria (7 listed)
- Use of assistive walking devices
- Chronic use of analgesic or anti-inflammatory drugs
- History of neuromuscular problems or muscle and/or bone wasting disease
- Acute or chronic illness including cardiac, pulmonary, liver or kidney abnormalities, uncontrolled hypertension, insulin or non-insulin dependent diabetes or other metabolic disorders
- Daily use of statins, particularly simvastatin and atorvastatin
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 |
|---|---|---|
| Normal Daily StepsComplete normal daily ambulation for one week | Behavioural | Change in physical activity for older adults |
| Step-ReductionReduce daily ambulation to fewer than 1000 steps per day for two weeks | Behavioural | Change in physical activity for older adults |
| Return to Normal Daily StepsIncrease daily ambulation to 100% of normal daily step-count for two weeks | Behavioural | Change in physical activity for older adults |
Primary outcome
Change in Insulin Sensitivity
Time frame: Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)
Assessed via Matsuda ISI
3 secondary outcomes
Change in lean tissue mass
Time frame: Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)
Change in Peak Isometric Maximal Voluntary Leg Extension Strength
Time frame: Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)
Change in Muscle Protein Synthesis
Time frame: Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)
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 1 Feb 2017.
- Background: PubMed 23589526Breen L, Stokes KA, Churchward-Venne TA, Moore DR, Baker SK, Smith K, Atherton PJ, Phillips SM. Two weeks of reduced activity decreases leg lean mass and induces "anabolic resistance" of myofibrillar protein synthesis in healthy elderly. J Clin Endocrinol Metab. 2013 Jun;98(6):2604-12. doi: 10.1210/jc.2013-1502. Epub 2013 Apr 15.
- Background: PubMed 26265753Devries MC, Breen L, Von Allmen M, MacDonald MJ, Moore DR, Offord EA, Horcajada MN, Breuille D, Phillips SM. Low-load resistance training during step-reduction attenuates declines in muscle mass and strength and enhances anabolic sensitivity in older men. Physiol Rep. 2015 Aug;3(8):e12493. doi: 10.14814/phy2.12493.
- Derived from this study: PubMed 29095970McGlory C, von Allmen MT, Stokes T, Morton RW, Hector AJ, Lago BA, Raphenya AR, Smith BK, McArthur AG, Steinberg GR, Baker SK, Phillips SM. Failed Recovery of Glycemic Control and Myofibrillar Protein Synthesis With 2 wk of Physical Inactivity in Overweight, Prediabetic Older Adults. J Gerontol A Biol Sci Med Sci. 2018 Jul 9;73(8):1070-1077. doi: 10.1093/gerona/glx203.
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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 Normal Daily Steps, Step-Reduction and Return to Normal Daily Steps in people with Older Adults and Reduced Physical Activity, run by McMaster University at 1 site in Canada.
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 7 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 1 Feb 2017. 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 Canada. 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?
Change in Insulin Sensitivity (time frame: Measured at the end of each behavioural intervention (Week 1, Week 3, Week 5)). 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 NCT03039556, which also lists 3 linked publications.
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 1 Feb 2017.