Trial Outcomes & Findings for Handgrip Exercise for Arteriovenous Fistula Maturation (NCT NCT01061008)

Results Overview

Measurements were made using duplex ultrasonagraphy. Measurements were made at predetermined distances 5 to 10 cm proximal to the anastomosis (dependent on wound dressings and turbulent flow around the anastomosis). The scanning position for each patient was traced using transparent sheets which allowed analogous measurement positions for all scans. Cross sectional vascular diameter measurements were made using conventional grey scale B Mode imaging. Diameters were measured from the inner edges of the vascular wall (Wiese \& Nonnast-Daniel, 2004).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

3 months

Results posted on

2014-07-15

Participant Flow

Patients with stage four and five CKD attending two renal units in North Wales, UK were invited to participate in the study.

Participant milestones

Participant milestones
Measure	Handgrip Exercise Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program	Treatment as Usual
Overall Study STARTED	16	15
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Handgrip Exercise Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program	Treatment as Usual
Overall Study Badiocephalic fistula failed	3	2
Overall Study Death	1	0
Overall Study Withdrawal by Subject	1	3
Overall Study Unable to exercise following surgery	1	0
Overall Study Adverse Event	0	1

Baseline Characteristics

Handgrip Exercise for Arteriovenous Fistula Maturation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Handgrip Exercise n=16 Participants Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program	Treatment as Usual n=15 Participants	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=93 Participants	15 Participants n=4 Participants	31 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	52 years STANDARD_DEVIATION 14 • n=93 Participants	60 years STANDARD_DEVIATION 11 • n=4 Participants	56 years STANDARD_DEVIATION 12 • n=27 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	4 Participants n=4 Participants	9 Participants n=27 Participants
Sex: Female, Male Male	11 Participants n=93 Participants	11 Participants n=4 Participants	22 Participants n=27 Participants
Region of Enrollment United Kingdom	16 participants n=93 Participants	15 participants n=4 Participants	31 participants n=27 Participants

PRIMARY outcome

Timeframe: 3 months

Measurements were made using duplex ultrasonagraphy. Measurements were made at predetermined distances 5 to 10 cm proximal to the anastomosis (dependent on wound dressings and turbulent flow around the anastomosis). The scanning position for each patient was traced using transparent sheets which allowed analogous measurement positions for all scans. Cross sectional vascular diameter measurements were made using conventional grey scale B Mode imaging. Diameters were measured from the inner edges of the vascular wall (Wiese \& Nonnast-Daniel, 2004).

Outcome measures

Outcome measures
Measure	Handgrip Exercise n=10 Participants Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program	Treatment as Usual n=9 Participants
Venous Diameter.	5.78 mm Standard Deviation 0.51	6.42 mm Standard Deviation 0.89

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

Adverse Events

Handgrip Exercise

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Treatment as Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Handgrip Exercise n=10 participants at risk Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program	Treatment as Usual n=9 participants at risk
Surgical and medical procedures Pain	20.0% 2/10 • Number of events 4 • 8 weeks Including joint, muscle or wound pain was recorded by the patient and also collected actively by the researcher during each weekly phone call to the patient. Other unexpected and serious (fatal, life threatening, or resulted in hospitalization) harms were collected passively as they occurred and during the trial period only.	0.00% 0/9 • 8 weeks Including joint, muscle or wound pain was recorded by the patient and also collected actively by the researcher during each weekly phone call to the patient. Other unexpected and serious (fatal, life threatening, or resulted in hospitalization) harms were collected passively as they occurred and during the trial period only.

Additional Information

Dr. Jamie Macdonald

UWalesBangor

Phone: +441248383272

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place