|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2015 |
|
Main ID: |
NCT02434289 |
|
Date of registration:
|
22/04/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Feasibility of a Resistance Exercise and Dietary Protein Intervention in Elderly People in Practice (ProMuscle 65PK)
|
|
Scientific title:
|
Pilot Study to Study the Feasibility and Potential Impact of a Combined Resistance Exercise and Increased Protein Intake Intervention in (Frail) Elderly People, in a Real-life Setting |
|
Date of first enrolment:
|
April 2015 |
|
Target sample size:
|
23 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02434289 |
|
Study type:
|
Interventional |
|
Study design:
|
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
Lisette de Groot, Professor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Wageningen University |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- In home assisted (also informal care) elderly individuals, that experience loss of
muscle strength
- Able to understand and perform the study procedures
Exclusion Criteria:
- Type I or type II diabetes (fasted blood glucose level =7,0 mmol) or hypertension,
unless well regulated by medication
- Diagnosed cancer or Chronic Obstructive Pulmonary Disease (COPD)
- Severe heart failure
- Renal insufficiency (eGFR <60 mL/min/1.73 m2)
- Newly placed hip/knee prosthesis (unless fully recovered), or recent surgery (stress
on scar tissue)
- Allergic or sensitive for milk proteins
Age minimum:
65 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Sarcopenia
|
|
Intervention(s)
|
|
Other: Resistance exercise training
|
|
Dietary Supplement: Dietary protein products
|
|
Primary Outcome(s)
|
|
Feasibility of intervention implementation
[Time Frame: After 12 weeks]
|
|
Secondary Outcome(s)
|
|
Change in skeletal muscle mass, as measured by Dual-energy X-ray Absorptiometry (DEXA)
[Time Frame: Baseline and 12 weeks]
|
|
Change in Activities of Daily Living (ADL) functioning, as measured by ADL-questionnaire
[Time Frame: Baseline and 12 weeks]
|
|
Change in muscle strength, as measured by a maximum strength test
[Time Frame: Baseline and 12 weeks]
|
|
Change in Quality of life, as measured by Short-Form 36 (SF-36)
[Time Frame: Baseline and 12 weeks]
|
|
Change in physical performance, as measured by Short Physical performance Battery (SPPB), Timed Up-and-Go (TUG) and Six Minute Walking Test (6MWT)
[Time Frame: Baseline and 12 weeks]
|
|
Secondary ID(s)
|
|
NL51834.081.14
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|