Primary Objective: (1) To study the efficacy of exercise therapy and CBT for reducing fatigue and improving activities and HRQoL in patients with PPS. Secondary Objectives: (2) To identify generic and disease-specific determinants of effects.(3) To…
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
At baseline, completion of the intervention and at 3- and 6-months follow-up,
fatigue (Checklist Individual Strength, domain fatigue), limitations in
activities (Sickness Impact Profile, domains: mobility range, mobility control,
social behaviour), HRQoL (SF-36), and secondary outcome measures will be
assessed.
Secondary outcome
Secundary outcome measures are pain, psychological well being,
cardiorespiratory fitness, neuromuscular capacity, physical activity level in
daily life, participation, functional capacity, self efficacy, illness
cognitions, coping and resource use.
Background summary
Postpoliomyelitis Syndrome (PPS) is a complex of neuromuscular symptoms that
appears in many survivors of paralytic polio, usually 15 years or more after
the acute illness. Subjects with PPS often complain of severe fatigue and
deterioration in functional abilities. The pathogenesis of PPS is probably
multifactorial. Since PPS is not considered curable, rehabilitation management
is the mainstay of treatment. To preserve functioning at the highest achievable
level, two distinctly different therapeutic interventions can be executed:
exercise therapy or cognitive behavioural therapy (CBT). However, evidence to
support either approach is still insufficient and understanding of the
underlying mechanisms of the approaches is unclear. We hypothesize that
exercise therapy and CBT are both effective in reducing fatigue, improving
activities and quality of life of patients with PPS compared to usual care.
There is need for rigorous, appropriately controlled assessment of the efficacy
of these interventions for PPS patients.
Study objective
Primary Objective:
(1) To study the efficacy of exercise therapy and CBT for reducing fatigue and
improving activities and HRQoL in patients with PPS.
Secondary Objectives:
(2) To identify generic and disease-specific determinants of effects.
(3) To evaluate the cost-effectiveness of each intervention compared to usual
care.
(4) To obtain insight into patients* expectations of and experiences with both
interventions.
Study design
A multi-centre, single-blinded, randomized controlled trial
Intervention
The 81 patients will be randomized to one of three groups i.e. (1) exercise
therapy + usual care, (2) CBT + usual care, (3) usual care.
Study burden and risks
All patients will be asked to visit the AMC at 4 times and the VU at 3 times
over the study period of 10 months to participate in a physical examination.
The duration of these examinations will be approximately 2 hours. Additionally,
patients will be asked to wear a small ankle-worn accelerometer for 7
consecutive days at the 4 different time measurements, and all patients receive
questionnaires to fill out at home. The duration for completing the
questionnaires is approximately 1,5 to 2 hours. At baseline patients will
receive cost diaries which they will send back every month during the 10
months. There are no costs related to the interventions for the patients.
Possible medical risks related to the physical examonations are considered
minimal and a physician will be present during the examinations. All
participating centres are well experienced in providing exercise therapy in
patients with different neuromuscular diseases. Therefore, the occurrence of
medical events is considered minimal. No risks are associated with CBT.
Considering the positive effects of both CBT as well as the exercise therapy
known from preliminary research it can be concluded that the benefits outweigh
the burden en minimal risk associated with this study.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
(1) diagnosis of PPS according to the criteria of March and Dimes i.e.
a. A confirmed history of paralytic poliomyelitis characterized by an acute illness with fever and a usually asymmetrically distributed, flaccid paresis of a varying number of muscle groups. Evidence of motor neuron loss on neurological examination with signs of residual weakness, atrophy, loss of tendon reflexes and intact sensation.
b. A period of partial or complete functional recovery after acute paralytic poliomyelitis, followed by an interval (usually 15 years or more) of stable neurologic function.
c. Gradual or sudden onset of progressive and persistent new muscle weakness or abnormal muscle fatigability (decreased endurance), with or without generalized fatigue, muscle atrophy, or muscle and joint pain. Symptoms persist for at least a year.
d. No other medical diagnosis to explain the symptoms (anemia and thyroid dysfunction
as a cause of fatigue will be ruled out by blood test).
(2) suffering from severe perceived fatigue (CIS-fatigue ><= 35)
(3) age between 18 and 70 years
(4) a life-expectancy longer than one year
(5) consultation (not necessarily the first consultation) of a neurologist or physical medicine and rehabilitation specialist in the previous 5 years
(6) walking-ability at least indoors with or without a walking aid
(7) ability to cycle on a bicycle ergometer against a load of at least 25 Watt.
Exclusion criteria
(1) cognitive impairment
(2) insufficient mastery of the Dutch language
(3) pregnancy
(4) use of psychotropic drugs (except simple sleeping medication) or other psychiatric treatment.
(5) use of medication causing fatigue
(6) disabling co-morbidity interfering with the intervention programs or influencing outcome
parameters (including cardiopulmonary disease like chest pain, arrhythmia, pacemaker, cardiac surgery, severe dyspnoea d*effort or emphysema, epileptic seizures, poorly regulated diabetes mellitus).
(7) respiratory insufficiency
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 |
|---|---|
| Other | 1371 |
| CCMO | NL23702.018.08 |