Trial record 6 of 1398 for:    "Mayo Clinic" [Exact]

Does Pulmonary Rehabilitation Improve Frailty?

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Cassie C. Kennedy, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02512874
First received: July 24, 2015
Last updated: July 29, 2015
Last verified: July 2015
  Purpose

Frailty is a state of health with predisposition to adverse events, morbidity and mortality. Frailty consists of weakness, slowness, low physical activity, exhaustion, and wasting. Frailty is associated with increased hospitalizations and death in lung disease. It is unknown if pulmonary rehabilitation will improve frailty markers.


Condition Intervention
Disease, Pulmonary
Other: Pulmonary Rehabilitation
Device: Dynamometer
Radiation: DEXA
Other: Gait Speed Test
Device: Activity Monitor
Other: Questionnaires

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Does Pulmonary Rehabilitation Improve Frailty in Chronic Lung Disease?

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in Frailty Phenotype [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Frailty phenotype is 3 or more of: slow gait speed, exhaustion, decreased hand grip strength, decreased activity level, or wasting. Grip strength parameters, gait speed, exhaustion per Fried et al. 2001. Wasting is defined as further decrease in fat free mass by body composition measurement using DEXA. Low physical activity would be activity monitor in lower quartile.


Secondary Outcome Measures:
  • Wasting [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Defined as a further decrease in fat free mass by body composition measured by DEXA. Loss of >10 pounds unintentionally.

  • Change in Strength [ Time Frame: Six Months ] [ Designated as safety issue: No ]
    Grip Strength - Dynamometer. Frailty characterized as lowest 20% by gender and body mass index.

  • Change in gait speed [ Time Frame: Six Months ] [ Designated as safety issue: No ]
    Fast gait speed test (15 feet). Frailty characterized as slowest 20% by walking time by gender and height.

  • Change in Exhaustion [ Time Frame: Six Months ] [ Designated as safety issue: No ]
    Self-reported exhaustion - measured by the CES-D scale.

  • Change in Activity [ Time Frame: Six Months ] [ Designated as safety issue: No ]
    Energy expenditure- Armband Activity Monitor. Low activity is defined as activity in the lowest 20% -0 <383Kcals/week for men or <270Kcals/week for women.


Estimated Enrollment: 100
Study Start Date: July 2015
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Pulmonary Rehabilitation
One arm study - all participants will go to pulmonary rehabilitation, received questionnaires, DEXA scans, Dynamometer and gait speed tests and activity measured through an activity monitor.
Other: Pulmonary Rehabilitation
Measures of frailty taken before and after pulmonary rehabilitation.
Device: Dynamometer
Grip Test
Radiation: DEXA
Body Composition Testing
Other: Gait Speed Test
15 foot walk test
Device: Activity Monitor
Measures energy expenditure and activity
Other: Questionnaires
Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms.

Detailed Description:

Individuals referred to pulmonary rehabilitation will be examined for frailty markers. After completing pulmonary rehabilitation, the same tests will be performed. The effects of pulmonary rehabilitation will be examined.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Referred for pulmonary rehabilitation
  • consenting to research
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02512874

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Cassie Kennedy, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Cassie C. Kennedy, M.D., Consultant for Critical Care Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02512874     History of Changes
Other Study ID Numbers: 15-001230
Study First Received: July 24, 2015
Last Updated: July 29, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 03, 2015