Primary objective:(1) To evaluate the efficacy of the B-FIT aerobic training program on physical fitness of individuals with PPS in the US and the Netherlands.Secondary objective:(2) To evaluate the patient and healthcare professional satisfaction…
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(1) Physical fitness
The primary endpoint will be the difference in peak oxygen uptake before- and
directly post-intervention.
Secondary outcome
(2) Patient and healthcare professional satisfaction
An online survey will be developed to evaluate the patient and healthcare
professional satisfaction with working according to the B-FIT aerobic training
guidelines in the US and the Netherlands. The patient survey includes questions
pertaining to the satisfaction with (1) the training program (e.g. feasibility,
incorporation into daily life, intensity) and (2) the patient manual (e.g.
clearness of instructions). The health care professional survey includes
questions pertaining to the satisfaction with (1) the training program (e.g.
possibility to use own clinical judgment and preferences), and (2) the
therapist manual (e.g. clearness of instructions). Answers are rated on a
5-point Likert scale (1 = very poor, 5 = very good).
(3) Daily activity
Measured through heart rate monitoring during 7 consecutive days, to establish
the total time spent in low, moderate and vigorous intensity activities.
Activity monitors will be used to determine the total step count during the 7
day period and subjects will also be asked to keep an activity diary.
(4) Perceived physical functioning
Perceived physical functioning will be administered with the ACTIVLIM
questionnaire. ACTIVLIM is a questionnaire on self-reported activity
limitations that was validated using the Rasch model. The questionnaire
consists of 22 daily activities of which the perceived difficulty in performing
the activity is scored.
(5) Health-related quality of life
Assessed using the Short Form 36-item Health Survey (SF36). The physical health
component scores and mental health component scores will be calculated.
(6) Adherence
Heart rate monitors will be used during training sessions to gain data that
will be used to establish the total time that participants train within their
prescribed individual heart rate zones.
Background summary
In individuals with post-polio syndrome (PPS), symptoms of muscle weakness,
fatigue and pain may lead to reduced physical activity and a sedentary
lifestyle. Physical inactivity causes deconditioning (i.e. reduced physical
fitness), which in turn, worsens health and physical functioning and threatens
the independence of this ageing population. Successfully breaking this vicious
circle of inactivity requires personally tailored physical activity programs
including aerobic exercise to improve physical fitness, but clear guidelines
are lacking. Therefore, we recently developed the B-FIT training guidelinethat
gives healthcare professionals and patients support in the prescription and
evaluation of personalized aerobic training in PPS. B-FIT was successfully
applied in a pilot study in rehabilitation centers in the Netherlands,
demonstrating its potential for clinical practice. However, a more
comprehensive study is required to determine the efficacy of the B-FIT training
program to improve physical fitness in PPS and to evaluate the patient and
healthcare professional satisfaction with the use of the B-FIT aerobic training
guideline on a larger international scale.
Study objective
Primary objective:
(1) To evaluate the efficacy of the B-FIT aerobic training program on physical
fitness of individuals with PPS in the US and the Netherlands.
Secondary objective:
(2) To evaluate the patient and healthcare professional satisfaction with the
use of the B-FIT aerobic training guideline in individuals with PPS in the
US and the Netherlands
(3) To evaluate the efficacy of the B-FIT aerobic training program on daily
activity, quality of life and perceived physical functioning of individuals
with
PPS in the US and the Netherlands.
Study design
A multicenter, single group, pre-post intervention study
Intervention
Participants will receive a 4-month personalized physical training program
according to the B-FIT training guidelines, with two low intensity and one high
intensity trianing session a week.
Study burden and risks
The intervention consists of a 4-month home-based training program, with 2 low
intensity sessions and 1 high intensity session per week. Study assessments
take place at baseline (T-1, T0), directly after intervention (T1) and 3 months
after intervention (T2). During assessments, participants perform an exercise
tests and fill out questionnaires. The duration of these assessments will be
approximately 1.5 hours. Additionally, patients will be asked to wear a heart
rate- and step count monitor for 7 consecutive days directly after T0, T1 and
T2. To check for contra-indications for exercise, a physician will thoroughly
examine the participants according to the guidelines by the American College of
Sports Medicine (ACSM). The study patients are recruited in PPS centers of
excellence in the Netherlands and the United States. In the Netherlands, all
outcome research and training program- related visits are conducted at the
Amsterdam UMC, location AMC. The AMC is well experienced in providing exercise
therapy in patients with different neuromuscular diseases. Therefore, the
occurrence of medical events is considered minimal. Considering the positive
effects of exercise therapy known from preliminary research it can be concluded
that the benefits outweigh the burden and minimal risk associated with this
study.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
(1) - prior paralytic poliomyelitis (confirmed by signs of residual weakness
and atrophy of muscles on neuromuscular examination, or with EMG) with or
without diagnosis of PPS (according to the March of Dimes criteria)
(2) Presence of a question for help indicative of impaired physical fitness
(3) Indication of physical inactivity
(4) Ability to achieve a Borg score of 14 or higher during the incremental
exercise test
(5) Minimum age of 18 years
Exclusion criteria
(1) Contraindication for exercise (based on the guidelines by the American
College of Sports Medicine) (2) Unable to follow verbal or written instructions.
(3) Insufficient mastery of the Dutch language.
(4) Engaged in an exercise program for a period longer than 4 weeks during the
last 6 months.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL69962.018.19 |